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ISO/HL7 27953 Individual Case Safety Report Validation Procedures

Version 0.1 Revision 201611151235 [word]
   

This document describes computer instructions for automating the validation of Individual Case Safety Report (ICSR). The scope of this document is based upon the schema conformance requirements for ISO/HL7 27953 and report content requirements for ICH E2B(R3) ICSR Implementation Guide (Version 5.01, 12 April 2013) and reporting to the Vaccine Adverse Event Reporting System (VAERS).

Readers should note that the validation procedures described in this document can also be used to validate ICH E2B(R3) compliant files. A link to the FDA Guidance for Industry, sample message instances, and other technical documents may be found on the FDA CBER Vaccine ICSR Implementation website at  http://www.fda.gov/forindustry/electronicsubmissionsgateway/ucm387293.htm

Appendix A Unit of Measure Value Set

Appendix B ISO Language Codes

1 ICSR Documents in General

1.1 Headers and Wrappers

1.1.1 General

Validation Procedures

1.1.1.1 XML is well formed and valid against the schema.

1.1.1.2 There are no data elements and attributes in addition to those described in this document.

1.1.1.3 There are no spaces in codes.

1.1.1.4 Codes do not have a code System Name attribute.

1.1.1.5 There are no future dates.

1.1.1.6 Display names are case insensitive.

1.1.1.7 Spaces are only included in id extensions where specifically noted.

1.1.1.8 WARNING: Letters in Globally/Universally Unique Identifiers (GUID/UUID) are lower case.

1.1.1.9 WARNING: There are no empty or incomplete elements except, in certain circumstances, code, state, title, text, and time (an id has a root, a code has a code system).

1.1.1.10 All MedDRA code values within an ICSR are drawn from the same MedDDRA version.

1.1.1.11 A MedDRA code contains eight (8) numeric digits.

1.1.1.12 A MedDRA version contains numbers and the "." Special character.

1.1.1.13 If there is no specific notification to the contrary, then postal code, if present, contains 1-15 alphanumeric characters.In case of no address information, a null flavor is provided.Acceptable characters also include characters typically used in formatting, including "-" and " ".

1.1.1.14 Telecom value begins with either tel: or mailto: or fax.However, in some cases, a null flavor is allowed along with the value.

1.1.1.15 A null value for a telecommunications address includes, as value, either "tel", "fax", or "mailto" in order to indicate which type of telecommunications address is not available.

1.1.1.16 Telephone number contains 1-33 alphanumeric characters. Acceptable characters also include characters typically used in formatting, including "(", ")", "-", " ". "+", " ".

1.1.1.17 If a report meets the local criteria for an expedited report (Observation code = 23), value = "true", then the report is considered a "serious report".

1.1.1.18 The UCUM (Unified Code for Units of Measure) system is used for units in physical quantities. The UCUM case sensitive representation is used for all such units when present within the physical quantity.

1.1.1.19 When a physical quantity appears as denominator designating the quantity of an ingredient, and represents a countable form, the unit of measure may be omitted.

1.1.1.20 In some cases, validation rules for a report depend on the country that a report is from - its source country. The source country is the country cited as the location code for the primary source reporter (location, as located entity for the author of the source report whose priority number = "1"), if a non-null country code is provided.

1.1.2 XML references

This is the reference to the character set, stylesheet, name space and schema

<?xml version="1.0" encoding="UTF-8"?>
<?xml-stylesheet 
    href="http://www.accessdata.fda.gov/icsr/stylesheet/icsr.xsl"?>

Validation Procedures

1.1.2.1 XML reference is for version 1.0 and encoding "UTF-8".

1.1.2.2 There is no schema Location reference.

1.1.2.3 There are no processing instructions other than the xml and xml-stylesheet declarations.

1.1.2.4 Response mode indicates that a deferred response is acceptable.

1.1.2.5 The batch "name" is used to record the type of message included in the batch.

2 Batch Wrapper

HL 7 provides a structure to allow transmission of messages in batches. The HL7 Documentation notes:

"There are instances when it is convenient to transfer a batch of HL7 interactions …. Such a batch could be sent online using a common file transfer protocol, or offline via tape or diskette. Although a batch will usually consist of a single type of interaction, there is nothing in the definition that restricts a batch to only one interaction type. It should be noted that the "unit of work" of HL7 is the interaction, not the batch. Thus some interactions contained within the batch may be successfully processed, while others are not."

The batch structure captures transactional information, and the identity of transaction sender and receiver is recorded. It is important to note that the message class, contained within the batch model "is a so-called stub which links the Batch class to the Message class." For ICSR messaging, the schema being used will only include the defined set of interactions.

2.1 Transactional Information

2.1.1 Batch Information

<MCCI_IN200100UV01 ITSVersion="XML_1.0" 
      xsi:schemaLocation="urn:hl7-org:v3 
                       http://www.accessdata.fda.gov/icsr/schema/icsr.xsd"
      xmlns="urn:hl7-org:v3" 
      xmlns:xsi="http://www.w3.org/2001/XMLSchema-instance">
  <id extension="1230ABC700" root="2.16.840.1.113883.3.989.2.1.3.22"/>
  <creationTime value="20101214151617"/>
  <responseModeCode code="D"/>
  <interactionId extension="MCCI_IN200100UV01" 
                 root="2.16.840.1.113883.1.6"/>
  <name code="ichicsr" codeSystem="2.16.840.1.113883.3.989.2.1.1.1"/>
  <PORR_IN049016UV>
    ...
  </PORR_IN049016UV>
  <receiver typeCode="RCV">
    <device classCode="DEV" determinerCode="INSTANCE">
      <id extension="ZZFDA" root="2.16.840.1.113883.3.989.2.1.3.14"/>      
    </device>
  </receiver>
  <sender typeCode="SND">
    <device classCode="DEV" determinerCode="INSTANCE">
      <id extension="123456789" root="1.3.6.1.4.1.519.1"/>    
    </device>
  </sender>
</MCCI_IN200100UV01>

Validation Procedures

2.1.1.1 There is an identifier for the batch.

2.1.1.2 Id extension is free text.

This static OID indicates the identifier is a batch identifier.

2.1.1.3 id (document id) is unique across all documents, sections and any other ids.

2.1.1.4 WARNING: Id root is 2.16.840.1.113883.3.989.2.1.3.22.

2.1.1.5 There is a creation time with at least the precision of second in the format CCYYMMDDhhmmss [+/-ZZzz]'. Time zone offset, consisting of "+" or "-" followed by 4 numeric characters, is included.

The value represents the date/time batch was assembled.

2.1.1.6 There is a response mode code whose value is Deferred (D), Immediate (I), or Queue (Q).

2.1.1.7 There is an interaction id.

2.1.1.8 WARNING: Id root is 2.16.840.1.113883.1.6.

An Object Identifier (OID) is a sequence of numbers to uniquely identify an object. The numbers represent a hierarchically-assigned namespace, formally defined using the International Telecommunications Union ASN.1 standard.  These numbers are written either as a string of digits separated by dots or as a list of named 'branches.' For example, the MedDRA dictionary of terms is identified by the OID 2.16.840.1.113883.6.163 which also represents the branch 'joint-iso-itu-t.country.us.organisation.hl7.external-code-system.MedDRA'.

Organizations can obtain an OID by requesting an identifier from a registrar, and, if it desires, an organisation can in turn become a registrar and subsequently generate child OIDs to its internal objects. The ICH is implementing OIDs to identify code systems used in ICSR message exchange.

This document uses the OIDs assigned by ICH with the exception of code systems and identifiers that are needed as US Regional Extensions. A list of OIDs registered by ICH is available on the ICH ESTRI webpage for E2B(R3) at: http://www.ich.org/products/electronic-standards.html.. In addition, some OIDs registered by HL7 are used in ICSR messages to differentiate the intended use of some elements (e.g. in data elements F.r.4 and F.r.5 for normal values of test results, different OIDs are used to differentiate between 'low' and 'high', respectively).Although those HL7 registered OIDs are not described in the tables below, the reference instance which has been provided provides all OIDs in the context they are used. ICH reference instances are provided in the ICH E2B(R3) Step 4 Implementation Package, FDA reference instances are available at:

2.1.1.9 Id extension is MCCI_IN200100UV01.

2.1.1.10 There is a name.

2.1.1.11 Name code is 1.

2.1.1.12 Code system is 2.16.840.1.113883.3.989.2.1.1.1.

2.1.1.13 There are one or more interactions contained within a batch.

The element content is discussed in Section 2Transmission/Control Act.

2.1.1.14 There is a batch receiver.

2.1.1.15 Id extension is the text entry "CBER_VAERS".

2.1.1.16 WARNING: Receiver id root is 2.16.840.1.113883.3.989.2.1.3.14.

This static OID has been assigned by ICH. It indicates the identifier refers to the batch receiving organization. Citing two ICH assigned OIDs, that for the batch receiver, and that for the transmission receiver, in the validation rule makes it possible to reuse the receiver participation.

2.1.1.17 There is a batch sender.

2.1.1.18 Id extension has the value chosen by the sender and optionally spaces.

2.1.1.19 WARNING: Sender id root is 2.16.840.1.113883.3.989.2.1.3.13.

Citing two ICH assigned OIDs, that for the batch sender, and that for the transmission sender, in the validation rule makes it possible to reuse the sender participation.

3 Transmission/Control Act

The HL7 documentation notes: "The "HL7 Transmission wrapper" includes information needed by a sending application or message handling service to package and route the V3 Composite Message to the designated receiving application(s) and/or message handling service(s). The structure is used to identify the sender and receiver of the message as well as carrying basic transactional information.

The HL7 documentation notes:

"The "Trigger Event Control Act" contains administrative information related to the "controlled act" which is being communicated as a messaging interaction. A Trigger Event Control Act describes the 'action' that is happening to the subject of the message (the payload). The Trigger Event Control Act contains details about the trigger event for the message such as who, when, where and why."

Since ICSR messaging simply addresses notifications related to actions that have already taken place, and the relevant information is carried in the body of the report (message payload), the contents of this model is not used.

Implementers should note that the schema for the control act is not included as part of the Implementation Guide material, although an element from the control act structure is contained within the schema for the ICSR interactions.

This data structure links to the investigation event - containing adverse event information and the other message content. This data structure is discussed in Section 4Investigation.

3.1 Administrative Information

3.1.1 Transmission Information

<MCCI_IN200100UV01>
...
  <PORR_IN049016UV>
    <id extension="231-XBH-89" root="2.16.840.1.113883.3.989.2.1.3.1"/>
    <creationTime value="20101214151617"/>
    <interactionId extension="PORR_IN049016UV" root="2.16.840.1.113883.1.6"/>
    <processingCode code="P"/>
    <processingModeCode code="T"/>
    <acceptAckCode code="AL"/>
      <receiver typeCode="RCV">
        <device classCode="DEV" determinerCode="INSTANCE">
          <id extension="83225549" root="2.16.840.1.113883.3.989.2.1.3.12"/>
         </device>
     </receiver>
     <sender typeCode="SND">
        <device classCode="DEV" determinerCode="INSTANCE">
          <id extension="555-82AB" root="2.16.840.1.113883.3.989.2.1.3.11"/>
        </device>
     </sender>

Validation Procedures

3.1.1.1 There is an identifier for the transmission.

This static OID has been assigned by ICH. It indicates the identifier refers to an interaction containing an ICSR message.

3.1.1.2 Id extension is a value provided by the message sender. The value should match the value provided as the Safety Report Unique Identifier - The investigation event id whose root OID = 2.16.840.1.113883.3.989.2.1.3.1.

This static OID indicates the identifier is a batch identifier.

3.1.1.3 WARNING: Id root is 2.16.840.1.113883.3.989.2.1.3.1.

3.1.1.4 There is a creation time with at least the precision of second in the format YYYYMMDDhhmmss [+/-ZZzz]. Time zone offset, consisting of "+" or "-"followed by 4 numeric characters, is included.

It records the date/time of message transmission.

3.1.1.5 There is a processing code whose value is either Debugging (D), Production (P), or Training (T).

3.1.1.6 There is a processing mode code whose value is either Archive (A), Initial load (I), Restore from archive (R), or T (Current processing).

3.1.1.7 There is an accept acknowledgement code whose value is Always (AL).

3.1.1.8 There is a receiver.

3.1.1.9 WARNING: Receiver id root is 2.16.840.1.113883.3.989.2.1.3.12.

3.1.1.10 Id extension is the text entry "CBER_VAERS".

3.1.1.11 There is a sender.

3.1.1.12 WARNING: Sender id root is 2.16.840.1.113883.3.989.2.1.3.11.

3.1.2 Control Act Process

<MCCI_IN200100UV01>
...
  <PORR_IN049016UV>
    <controlActProcess classCode="CACT" moodCode="EVN">
      <code code="PORR_TE049016UV" codeSystem="2.16.840.1.113883.1.18"/>
         <effectiveTime value="20101214151300"/>
      <subject typeCode="SUBJ">

Validation Procedures

3.1.2.1 There is a control act process code.

3.1.2.2 The code is PORR_TE049016UV.

3.1.2.3 Code system is 2.16.840.1.113883.1.18.

The static OID has been assigned by HL7.

3.1.2.4 There is an effective time with at least the precision of second in the format YYYYMMDDhhmmss [+/-ZZzz]. Time zone offset is included.

This data element has the function of a timestamp and represents the equivalent of a version number for the ICSR. Every ICSR and every iteration (e.g. version) of an ICSR in a safety message must have a different value for Date of Creation. The most recent version of an ICSR will have the most recent date; previous versions of an ICSR will have older dates.

4 Investigation

The investigation event structure captures the case narrative information and includes the unique report ID and relevant date information which are used to help reconcile initial and follow up ICSRs. The investigation is the central element within the ICSR structure, and provides an entry point to the following:

There may be one or more reference element. The reference element provides information about documents related to the investigation. Its content is discussed in Section 5Reference Documents.

There is a component element. The component provides information about the adverse event assessment(s), and information about the adverse event subject (e.g., patient). Its content is discussed in Section6Event Assessment & Person Subject.

There may be one or more component elements. The component element provides additional information about the adverse event assessment. Its content is discussed in Section6Event Assessment & Person Subject.

There may be one or more outbound relationship elements. The outbound relationship element provides information about other reports (e.g., retransmissions or other source reports) associated with the current ICSR investigation. Content for this element is discussed in Section 16Adverse Event Source Reports, Section 17Adverse Event First Sender, and Section 18Related Reports.

There is a subjectOf1 element containing a control act element. The control act provides information about the sender and receiver of ICSR reports. Its content is discussed in Section19Report Responsible Party.

There may be one or more subjectOf1 elements containing a control act element. This control act provides information about other case report identifiers assigned by other senders of the same ICSR case. Its content is discussed in Section18Related Reports.

There may be one or more subjectOf2 relationship elements. The elements provide additional information for the investigation and report. Its content is discussed in Section22Investigation Characteristics.

4.1 Investigation Event Information

<MCCI_IN200100UV01>
  <PORR_IN049016UV>
    <subject>
      <investigationEvent classCode="INVSTG" moodCode="EVN"/>
        <id root="2.16.840.1.113883.3.989.2.1.3.1" 
            extension="FR-companyname-12345"/>
        <id root="2.16.840.1.113883.3.989.2.1.3.2" 
            extension="FR-companyname-12345"/>
        <code code="PAT_ADV_EVNT" codeSystem="2.16.840.1.113883.5.4"
              displayName="human drug adverse event investigation"/>
        <text mediaTyp="text/plain">CThis is where the case Nnarrative... should go ...</text>
        <statusCode code="active"/>
        <effectiveTime>
          <low value="2009080628"/>
        </effectiveTime>
        <availabilityTime value="20090807060504.000"/>

Validation Procedures

4.1.1.1 There is an id containing Safety Report Unique Identifier.

This static OID has been assigned by ICH. It indicates the identifier refers to the company assigned id.

4.1.1.2 Id extension is a value provided by the message sender. The value should match the value provided as the message identifier - The transmission id whose root OID = 2.16.840.1.113883.3.989.2.1.3.1.

4.1.1.3 Id root is 2.16.840.1.113883.3.989.2.1.3.1.

4.1.1.4 There is a World Wide Unique Case Identification Number.

Id extension is a value provided by the message sender.

ICH Notes: 'This data element contains an identifier for the ICSR that is unique. The value should be a concatenation of3 segments separated by a dash/hyphen: 'country code-company or regulator name-report number'. Country code is the 2-letter ISO 3166 part 1 code (ISO 3166-1 alpha-2) corresponding to the country of the primary source of the report (C.2.r.3); in exceptional circumstances where the country of primary source is unknown, the country where the reaction occurred (E.i.9) should be used to indicate the country code. The company or regulator name is an internationally unique abbreviation or code for the sender's organisation; the use of a '-' (dash/hyphen) should be avoided in this segment. The report number is the organisation's international case number. For example, a report transmitted from a company to a regulatory authority concerning a case from France would populate C.1.1 with 'FR-companyname-12345' where 12345 is that company's unique case report number.

When the same sender retransmits the same case (e.g. to transmit follow-up information), the sender's case id usually remains constant. Exceptions are: a) In the case of an organisational change, (e.g. a merger between companies or a name change), follow-up reports can be identified in by the identifier of the newly named organisation. B) In the case of changes of country code for primary source for regulatory purposes or the country where the reaction occurred (E.i.9), the identifier can be changed.

4.1.1.5 There is an id extension with value provided by the first message sender. The world wide case id will differ from the unique id if the current sender is not the first sender for the ICSR.

4.1.1.6 If the investigation event id has been previously submitted then there is a nullification amendment code isnullification (1) or amendment (2).

4.1.1.7 If there is a nullification amendment code v nullification (1) or amendment (2) then there is an investigation event previously submitted under this id.

4.1.1.8 Id root is 2.16.840.1.113883.3.989.2.1.3.2.

This static OID has been assigned by ICH. It indicates the identifier refers to the world wide case id.

ICH Notes: 'This data element contains an identifier for the ICSR that is unique. The value should be a concatenation of3 segments separated by a dash/hyphen: 'country code-company or regulator name-report number'. Country code is the 2-letter ISO 3166 part 1 code (ISO 3166-1 alpha-2) corresponding to the country of the primary source of the report (C.2.r.3); in exceptional circumstances where the country of primary source is unknown, the country where the reaction occurred (E.i.9) should be used to indicate the country code. The company or regulator name is an internationally unique abbreviation or code for the sender's organisation; the use of a '-' (dash/hyphen) should be avoided in this segment. The report number is the organisation's international case number. For example, a report transmitted from a company to a regulatory authority concerning a case from France would populate C.1.1 with 'FR-companyname-12345' where 12345 is that company's unique case report number.

4.1.1.9 There is a code whose value is PAT_ADV_EVNT. The code value indicates the type of investigation information.

The value is static and fixed.

4.1.1.10 Code System is 2.16.840.1.113883.5.4.

This static OID has been assigned by ICH. It indicates the code system which contains values for investigation code.

4.1.1.11 There is text with the maximum length of 10,000 characters.

The case narrative should be a focused, factual and clear description of the case, including the clinical course, therapeutic measures, outcome and additional relevant information.

4.1.1.12 There is a Status code whose default value is active.

4.1.1.13 Effective time low boundary has at least the precision of day in the formatYYYYMMDD. Also, if hour information included, then time zone offset, consisting of "+" or "-"followed by 4 numeric characters, is included.

The effective time indicates the date on which information regarding the adverse event was first received from the primary source reporter.

4.1.1.14 There is an availability time with at least the precision of day in the format YYYYMMDD. Also, if the time of day information provided, then the date includes time zone offset.

Availability time records the most recent date on which information related to the investigation was received. This data element must be populated for all follow up ICSRs.

5 Reference Documents

Information captured in this section describes documents related to the investigation that are being held or sent as ICSR attachments by the sender.

5.1 Document

<MCCI_IN200100UV01>
     <PORR_IN049016UV>
        <subject>
            <investigationEvent>
                <reference typeCode="REFR">
                    <document classCode="DOC" moodCode="EVN">
                        <code code="1" displayName="documentHeldBySender" codeSystem="2.16.840.1.113883.3.989.2.1.1.27"/>
                        <title>DoucumentTitle</title>
                        <text mediaType="application/pdf" representation="B64">
                         <reference value="companyFolder/filename.pdf"/>
                        Text on this patient case.
                        </text>

Validation Procedures

5.1.1.1 If there is an observation recording the availability of new documents (Observation code = 1) and it has the value "true", then document information is provided.

5.1.1.2 If the observation recording the availability of new documents (Observation code = 1) and it has the value "true", then at least one instance where code = "1" is be present.

5.1.1.3 If the observation recording the availability of new documents (Observation code = 1) does not have the value "true", then no instance where code = "1" is present.

5.1.1.4 There is a reference document code having value which is either Document held by sender (1) or Literature article (2).

5.1.1.5 WARNING: Display name for reference document code matches the code.

The element provides information for documents related to the investigation.

5.1.1.6 Code system is 2.16.840.1.113883.3.989.2.1.1.27

5.1.1.7 If reference document code = "1", then there is a title. Otherwise title is not included.

The title provides a name for the document.

5.1.1.8 There may be document text.

5.1.1.9 Text element includes a media type whose value comes from media type list.

Table 1. Allowable Attachment Types

File Extension Media Type Description
bmp Image/bmp Bitmap image format
doc application/msword Word processing document format
docx application/msword Word processing document format
gif Image/gif Graphics interchange format
jpeg Image/jpeg Image file formats
jpg Image/jpeg Image file formats
pdf application/pdf Portable document format
png image/png Portable network graphics
rtf application/rtf Rich text format
tif image/tiff Tagged image file format
tiff image/tiff Tagged image file format
txt text/plain Text format
wpd application/wordperfect Word processing document format
xls application/excel Spreadsheet file format
xlsx application/excel Spreadsheet file format

Text contains the content of the referred to document, i.e., that embeds the document text.

5.1.1.10 Representation information is base 64 (B64).

5.1.1.11 There may be document reference to provide a file location for the document content.

Within the XML instance, the reference element should be included before text content of the text element.

5.1.1.12 The File type declared for the document reference matches the stated media type.

6 Event Assessment & Person Subject

When an adverse event is recorded for a person, a number of relevant items are collected.HL7 null flavor values are acceptable for no more than two (2) data elements in this section. The event assessment includes the following elements within it.

There may be one or more role elements to capture information about other subjects that are related to the investigative subject. The content of this element is discussed in Section 7Related Subject.

There may be one or more subjectOf1 elements to capture information about clinical trials in which the investigative subject is enrolled. The content of this element is discussed in Section14Research Study Relationship.

There may be one or more subjectOf2 elements to capture relevant information for the adverse event assessment(s) for the investigative subject. The content of this element is discussed in Section11Product Information.

ICSRs capture information about the investigation into an event associated with the use of a product. The product may be consumed through a substance administration or used in the context of a procedure, e.g., a medical device. In either case, information is collected for the specific product instance, and for the type of product involved. Note, however, that the key product instance information is recorded within the context of the product's dosage details.

6.1 Event Assessment and Person Subject Information

6.1.1 Investigative Subject in General

<MCCI_IN200100UV01>
  <PORR_IN049016UV>
    <subject>
      <investigationEvent>
      <component typeCode="COMP">
        <adverseEventAssessment classCode="INVSTG" moodCode="EVN">
          <subject1 typeCode="SBJ">
            <primaryRole classCode="INVSBJ">
              <player1 classCode="PSN" determinerCode="INSTANCE">

Validation Procedures

6.1.1.1 There is an adverse event assessment.

6.1.1.2 Adverse event Class code and mood code are as above.

6.1.1.3 There is at least one investigation subject.

6.1.1.4 Primary role class code is as above.

6.1.1.5 There is a subject name and in case primary source reporter, name can be omitted. And in case unavailability of name information, the null flavors ASKU or NASK may be provided.

6.1.2 Patient Name

<investigationEvent>
  <component typeCode="COMP">
    <adverseEventAssessment classCode="INVSTG" moodCode="EVN">
      <subject1 typeCode="SBJ">
        <primaryRole classCode="INVSBJ">
          <player1 classCode="PSN" determinerCode="INSTANCE">
            <name>
              <prefix>Mr.</prefix>
                <given>John</given>
                <given>James</given>
                <family>Doe</family>
            </name>

Validation Procedures

A patient identifier must be provided and will vary by reporting program. For FAERS: Use the patient initials or a generic Id. For VAERS reporting, full patient name information is required.

6.1.2.1 There is name information. However, if the primary source reporter role played by the patient(qualified entity code = C16960 "patient"), then name information can be omitted.

6.1.2.2 There is a family name. However, if the primary source reporter role played by the patient(qualified entity code = C16960 "patient"), then name information can be omitted.

6.1.2.3 If family name is unavailable, then the null flavors MSK, ASKU and NASK are used to indicate lack of information, MSK should not be used for source country US.

6.1.2.4 There is a First name. However, if the primary source reporter role played by the patient(qualified entity code = C16960 "patient"), then name information can be omitted.

6.1.2.5 If first name is unavailable, then the null flavors MSK, ASKU and NASK are used to indicate lack of information, MSK should not be used for source country US.

The subject's first name is provided as text within the given name element. First name is distinguished from middle name by the ordering of elements within the name element.

6.1.2.6 If there is a middle name then it is provided after first name, but no additional given names are supported.

6.1.2.7 If there is a middle name and information is unavailable then it is indicated using the null flavors MSK, ASKU or NASK.

The subject's middle name is provided as text within the given name element. Middle name is distinguished from first name by the ordering of elements within the name element.

6.1.3 Patient Details

<investigationEvent>
  <component typeCode="COMP">
    <adverseEventAssessment classCode="INVSTG" moodCode="EVN">
      <subject1 typeCode="SBJ">
        <primaryRole classCode="INVSBJ">
          <player1 classCode="PSN" determinerCode="INSTANCE">
            <name />
            <telecom value="tel:9874562222"" />
            <telecom value="mailto:email@org.edu" />
            <administrativeGenderCode code="M" codeSystem="1.0.5218" />
            <birthTime value="19450607" />
            <deceasedTime value="20000102" />
            <addr>
              <streetAddressLine>44 Elm lane</streetAddressLine>
              <streetAddressLine>Apt. 2003</streetAddressLine>
              <city>Metropolis</city>
              <state>Northside</state>
              <postalCode>54321</postalCode>
            </addr>

Validation Procedures

6.1.3.1 There is a patient address. However, if the primary source reporter having a patient (qualified entity code = C16960 "patient"), then address information can be omitted.

6.1.3.2 If patient is not the primary source reporter, then address for the patient includes county.

6.1.3.3 If patient is not the primary source reporter, then there is address line. The null flavors MSK, ASKU, NASK are used to indicate lack of information, MSK is not used for source country US.

6.1.3.4 There may be an additional address line. The null flavor MSK may be used.

6.1.3.5 If patient is not the primary source reporter, then there is a city. The null flavors MSK, ASKU, NASK are used to indicate lack of information, MSK is not used for source country US.

6.1.3.6 If patient is not the primary source reporter, then there is a state.The null flavors ASKU, NASK, MSK and NI are used to indicate lack of information, MSK and NI are not used for source country US.

6.1.3.7 If the US is the source country and state is not null, then state must be one of the two letter abbreviations, either upper case or lower case, used by the US Postal Service.

6.1.3.8 If patient is not the primary source reporter, then there is a county. The null flavors MSK, ASKU, NASK and NI are used to indicate lack of information, MSK and NI are not used for source country US.

6.1.3.9 If patient is not the primary source reporter, then there is a postal code.The null flavors MSK, ASKU, and NASK are used to indicate lack of information, MSK is not used for source country US.

6.1.3.10 If patient is not the primary source reporter, then there is a country.The null flavors MSK can be used to indicate lack of information, MSK and NI are not used for source country US.Valid country codes are drawn from the ISO 3166-1 alpha-2 code system. The value "EU" is also to be accepted.

6.1.3.11 If patient is not the primary source reporter, then there is a telephone number. The null flavors ASKU, NASK are used to indicate lack of information, MSK is not used for source country US.

6.1.3.12 If patient is not the primary source reporter, then there is an email address. The null flavors ASKU, NASK are used to indicate lack of information, MSK is not used for source country US.

6.1.3.13 There can be an administrativeGenderCode whose value is either Male (1) or Female (2) and if, no gender information available, then nullflavor UNK, MSK, ASKU,NASK are allowed.

If the sex is known to the sender but cannot be transmitted due to data privacy requirements, then leave the data element and use the nullFlavor element with 'MSK' (masked).

6.1.3.14 If gender information is provided and not null, then code system is 1.0.5218.

6.1.3.15 There can be a birth date with at least the precision of year in the format YYYYMMDD and, if unavailable, then null flavor MSK is allowed.

6.1.3.16 Age calculated on the basis of birth date is not greater than 120 years.

Allowable null flavor can be used to indicate if the value is masked (MSK) due to privacy restrictions

6.1.3.17 There may be a date of death with at least the precision of year in the format YYYYMMDD.

Note, the death indicator should not be valued.

6.1.3.18 If the seriousness criteria "resultsInDeath" (observation value = "34") is recorded as "true", then Date of death is provided.Also, if the date is unavailable then the null flavors MSK, ASKU, NASK are allowed.

6.1.3.19 If the case qualifies for expedited reporting (if Adverse Event Assessment observation (Observation code = "23") has the value "true") then there is an address.

6.1.3.20 The null flavors MSK, ASKU, and NASK may be used for non-US cases.

6.1.3.21 The null flavors ASKU and NASK may be used for US cases.

6.1.4 Investigation Subject Identifier

<investigationEvent>
  <component typeCode="COMP">
    <adverseEventAssessment classCode="INVSTG" moodCode="EVN">
      <subject1 typeCode="SBJ">
        <primaryRole classCode="INVSBJ">
          <player1 classCode="PSN" determinerCode="INSTANCE">
            <addr/>
            <asIdentifiedEntity classCode="IDENT">
              <id root=""2.16.840.1.113883.3.989.2.1.3.7"" extension=""344AB"" />
              <code code=""1"" displayName=""GP"" CodeSystem=""2.16.840.1.113883.3.989.2.1.1.4"" />
            </asIdentifiedEntity>
            <asIdentifiedEntity classCode="IDENT">
              <id root=""2.16.840.1.113883.3.989.2.1.3.8"" extension=""344AB"" />
              <code code=""2"" displayName=""specialistmrn"" CodeSystem=""2.16.840.1.113883.3.989.2.1.1.4"" />
            </asIdentifiedEntity>
            <asIdentifiedEntity classCode="IDENT">
              <id root=""2.16.840.1.113883.3.989.2.1.3.9"" extension=""344AB"" />
              <code code=""3"" displayName=""hospitalMrn"" CodeSystem=""2.16.840.1.113883.3.989.2.1.1.4"" />
            </asIdentifiedEntity>
            <asIdentifiedEntity classCode="IDENT">
              <id root=""2.16.840.1.113883.3.989.2.1.3.10"" extension=""344AB"" />
              <code code=""4"" displayName=""investigation"" CodeSystem=""2.16.840.1.113883.3.989.2.1.1.4"" />
            </asIdentifiedEntity>
          </player1>
        </primaryRole>
</investigationEvent> 

This information is only collected for US based adverse event reporting.

There may different medical record numbers assigned to a patient. The ICSR implementation guide distinguishes between medical record numbers issued by a general practitioner, by a medical specialist, by a hospital, and by an investigator. Each medical record number type will use a different ID root and code OID. For ICH E2B(R3), the displayName element may be used. If a general practitioner assigned a medical record number, the identifier is recorded using the "asIdentifiedEntity" structure.

Validation Procedures

6.1.4.1 There may be several identifiers for the investigation subject.

6.1.4.2 Id root contains an Object Identifier (OID) that identifies the name space for the identifier value.

6.1.4.3 The id extension contains the identifier value. if unavailable, then nullflavor MSK is allowed.

There is no specific format for MRN, so extension may be treated as free text.

6.1.4.4 There is an Identified Entity code whose value is either GP (1), or Specialist (2), or Hospital Record (3), or Investigation (4).

6.1.4.5 WARNING: Display name for identified entity code matches the code.

6.1.4.6 Code System is 2.16.840.1.113883.3.989.2.1.1.4.

7 Related Subject

There are cases in which information is collected for other persons related to the investigative subject. The most usual case occurs when a mother uses a product and the adverse event is suffered by a nursing infant or an unborn fetus. Clinical information pertaining to related subjects is described in the Section 13Related Subject Clinical History.

There may be one or more subjectOf1 elements to capture information about clinical trials in which the related person is enrolled. The content of this element is discussed in Section 14Research Study Relationship.

There may be one or more subjectOf2 elements to capture relevant information for the adverse event assessment that is related to the person associated with the investigation subject. The content of this element is discussed in Section 13Related Subject Clinical History.

7.1 Related Subject Information

7.1.1 Code and CodeSystem

<adverseEventAssessment>
  ...
  <player1>
    ...
    <asIdentifiedEntity/>
    <role classCode="PRS">
       <code code="PRN" codeSystem="2.16.840.1.113883.5.111"/>
    </role>
  </player1>

Validation Procedures

7.1.1.1 There may be one or more persons who have a personal relationship to the investigation subject.

For drug and vaccine reporting, personal information is collected to support the use case in which a substance provided to the parent is suspected of causing a reaction in a fetus or infant. Sibling information consistent with the VAERS 1 form will not be stored or processed

7.1.1.2 Role class code is as above.

7.1.1.3 WARNING: The role code "PRN" (parent) is expected for the related person.

7.1.1.4 Code system is 2.16.840.1.113883.5.111.

7.1.2 Personal Information

<player1>
  ... 
  <asIdentifiedEntity />
  <role classCode="PRS">
    <code />
    <associatedPerson classCode=""PSN"" determinerCode=""INSTANCE"">
      <name>
        <family>Doe</family>
        <given>John</given>
        <given>Quentin</given>
      </name>
      <administrativeGenderCode code="M" codeSystem="1.0.5218" />
      <birthTime value="19450607" />
    </associatedPerson>
  </role>
</player1>

Validation Procedures

7.1.2.1 If parent information is provided, then there is a related subject name and, if unavailable, then null flavors MSK, ASKU, NASK, UNK can be used to indicate missing or unavailable information.

The name is recorded if available, and if legally sanctioned. (Sibling names are not recorded for vaccine reports.) A null flavor should be used to indicate if the name value is either unknown or masked. Note that, for parent-child/fetus reports, parent information is required.

7.1.2.2 If parent information is provided, then there is an administrativeGenderCode whose value is either Male (1) or Female (2) and if, no gender information available then nullflavor UNK, MSK, ASKU,NASK are allowed.

7.1.2.3 If there is a birth date with at least the precision of year in the format CCYYMMDD, and it is unavailable; then null flavors MSK, ASKU, NASK are used to indicate missing or unavailable information.

Allowable null flavors can be used to indicate if the gender value is: unknown (UNK) masked (MSK), asked but unknown (ASKU) or not asked(NASK)..

8 Adverse Reaction/Event

Information about the adverse reaction/event experienced by the investigative subject is the core information that must be populated in the report and must be linked appropriately to any related causality assessments. Each reported event/reaction is reported as an observation.

8.1 Adverse Reaction/Event Information

8.1.1 Code and Identifier

<MCCI_IN200100UV01>
... 
  <PORR_IN049016UV>
  ... 
    <component>
      <adverseEventAssessment>
      <subject1>
        <primaryRole>
        <subjectOf2 typeCode="SBJ">
          <observation classCode="OBS" moodCode="EVN">
          <id root="154eb889-958b-45f2-a02f-42d4d6f4657f" />
          <code code="29" displayName="reaction"
          codeSystem="2.16.840.1.113883.3.989.2.1.1.19" />
          <effectiveTime xsi:type="IVL_TS">
            <low value="20130104" />
            <high value="2030214" />
          </effectiveTime>
          <value xsi:type="CE" code="E.i.2.1b"
          codeSystem="2.16.840.1.113883.6.163"
          codeSystemVersion="12.0">
            <originalText language="E.i.1.1b">
            E.i.1.1a</originalText>
          </value>
          <location typeCode="LOC">
            <locatedEntity classCode="LOCE">
            <locatedPlace classCode="COUNTRY"
            determinerCode="INSTANCE">
              <code codeSystem="1.0.3166.1.2.2" />
            </locatedPlace>
            </locatedEntity>
          </location>
          </observation>
        </subjectOf2>
        </primaryRole>
      </subject1>
      </adverseEventAssessment>
    </component>
  </PORR_IN049016UV>
...
</MCCI_IN200100UV01>

Validation Procedures

8.1.1.1 Class code and mood code are as above.

8.1.1.2 There is an observation ID.

The observation id is used to provide a point of reference to link the causality assessment results and when recording the temporal relationship between reactions and substance administrations for the suspect product.

8.1.1.3 WARNING: Identifier root is a GUID/UUID.

8.1.1.4 The assigned observation id uniquely identifies the adverse reaction/event within the ICSR.

8.1.1.5 There is an observation code.

8.1.1.6 Code system is 2.16.840.1.113883.3.989.2.1.1.19.

8.1.1.7 The code is 29.

8.1.1.8 WARNING: Display name "reaction" matches the code.

8.1.1.9 There is effective time information that indicates at least the start or stopping point of the reaction, or its duration. If unavailable, the null flavors MSK, ASKU, NASK is used to indicate missing or unavailable information.

8.1.1.10 The decimal expression of the reaction duration value will have no more than 3 digits before the decimal place and no more than 2 digits after it.

8.1.1.11 The unit of measure for the reaction duration is a UCUM expression for time duration. Second, minute, hour, week, day, month and year are allowed.

8.1.1.12 WARNING: If reaction duration (width) is present, then there is not start date as well as end date present.

8.1.1.13 Code system is 2.16.840.1.113883.6.163 (MedDRA).

8.1.1.14 There is a Code system version.

8.1.1.15 If original text is included, then it records the reaction as reported in the native language of the reporter.

The language property of original text records the native language of the reporter - the person providing the description. Allowed values for language are drawn from ISO 639-2/RA, alpha-3 (OID: 2.16.840.1.113883.6.100).

8.1.1.16 If original text is included, then the language of the reaction information is recorded.

8.1.1.17 If original text is included, then the valid values for the language attribute are drawn from the list of language codes documented in Appendix B - ISO Language Codes. Code values are drawn from the ISO 639-2/RA, alpha-3 code system. Language code values

8.1.1.18 There may be a country code.

For vaccine reporting, the VAERS vaccination facility address should be used to populate ICH G.k.2.4 Identification of the Country Where the Drug Was Obtained when known. Other data elements for the VAERS vaccination facility information are related to the substance administration author, (VAERS Responsible Physician's Facility Address).

8.1.1.19 If country code for the primary reporter is not provided, then country code for the reaction location must be provided

8.1.1.20 Code system for country code is 1.0.3166.1.2.2.

8.1.1.21 Valid country codes are drawn from the ISO 3166-1 alpha-2 code system. The value "EU" is also to be accepted.

8.1.1.22 If country code is not present or is null for the primary source reporter, then the source country is the country cited as the location for the reaction (adverse event) suffered by the patient.

8.1.2 Adverse Reaction/Event Report

<primaryRole>
  <subjectOf2 typeCode="SBJ">
    <observation classCode="OBS" moodCode="EVN">      
      <outboundRelationship2 typeCode="PERT">
        <observation classCode="OBS" moodCode="EVN">
          <code code="30" displayName="reactionForTranslation" codeSystem="2.16.840.1.113883.3.989.2.1.1.19"/>
          <value xsi:type="ED">Altered Consciousness</value>
        </observation>
      </outboundRelationship2>
      <outboundRelationship2 typeCode="PERT">
        <observation classCode="OBS" moodCode="EVN">
          <code code="37" displayName="termHighlightedByReporter" codeSystem="2.16.840.1.113883.3.989.2.1.1.19"/>
          <value xsi:type="CE" code="1234-5" codeSystem="2.16.840.1.113883.3.989.2.1.1.10" displayName="No, not highlighted by the reporter, NOT serious"/>
        </observation>
      </outboundRelationship2>
      <outboundRelationship2 typeCode="PERT">
        <observation classCode="OBS" moodCode="EVN">
          <code code="34" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" displayName="resultsInDeath"/>
          <value xsi:type="BL" nullFlavor="NI"/>
        </observation>
      </outboundRelationship2>
      <outboundRelationship2 typeCode="PERT">
        <observation classCode="OBS" moodCode="EVN">
          <code code="21" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" displayName="isLifeThreatening"/>
          <value xsi:type="BL" nullFlavor="NI"/>
        </observation>
      </outboundRelationship2>
      <outboundRelationship2 typeCode="PERT">
        <observation classCode="OBS" moodCode="EVN">
          <code code="33" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" displayName="requiresInpatientHospitalization"/>
          <value xsi:type="BL" value="true"/>          
        </observation>
      </outboundRelationship2>
      <outboundRelationship2 typeCode="PERT">
        <observation classCode="OBS" moodCode="EVN">
          <code code="35" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" displayName="resultsInPersistentOrSignificantDisability"/>
          <value xsi:type="BL" nullFlavor="NI"/>
        </observation>
      </outboundRelationship2>
      <outboundRelationship2 typeCode="PERT">
        <observation classCode="OBS" moodCode="EVN">
          <code code="12" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" displayName="congenitalAnomalyBirthDefect"/>
          <value xsi:type="BL" nullFlavor="NI"/>
        </observation>
      </outboundRelationship2>
      <outboundRelationship2 typeCode="PERT">
        <observation classCode="OBS" moodCode="EVN">
          <code code="26" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" displayName="otherMedicallyImportantCondition"/>
          <value xsi:type="BL" nullFlavor="NI"/>
        </observation>
      </outboundRelationship2>
      <outboundRelationship2 typeCode="PERT">
        <observation classCode="OBS" moodCode="EVN">
          <code code="C53513" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="Emergency Room"/>
          <value xsi:type="BL" nullFlavor="NI"/>
        </observation>
      </outboundRelationship2>
      <outboundRelationship2 typeCode="PERT">
        <observation classCode="OBS" moodCode="EVN">
          <code code="C16988" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="Physician Offfice"/>
          <value xsi:type="BL" nullFlavor="NI"/>
        </observation>
      </outboundRelationship2>
      <outboundRelationship2 typeCode="PERT">
        <observation classCode="OBS" moodCode="EVN">
          <code code="C102450" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="Resulted in Prolongation of Hospitalization"/>
          <value xsi:type="BL" nullFlavor="NI"/>
        </observation>
      </outboundRelationship2>
      <outboundRelationship2 typeCode="PERT">
        <observation classCode="OBS" moodCode="EVN">
          <code code="C50414" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="Hospitalization required"/>
          <value xsi:type="BL" value="true"/>
          <outboundRelationship2 typeCode="PERT">
             <observation classCode="OBS" moodCode="EVN">
              <code code="C102443" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="Number of Hospitalization Days"/>
              <value xsi:type="INT" value="5"/> 
                <performer typeCode="PRF">
                  <assignedEntity classCode="ASSIGNED">
                    <representedOrganization classCode="ORG" determinerCode="INSTANCE">
                      <name>Memorial Hospital</name>
                      <addr>
                        <city>Metropolis</city>
                        <state>Pennsylvania</state>
                      </addr>
                    </representedOrganization>
                   </assignedEntity>
                </performer>
            </observation>
          </outboundRelationship2>
        </observation>
      </outboundRelationship2>
      <outboundRelationship2 typeCode="PERT">
         <observation classCode="OBS" moodCode="EVN">
          <code code="27" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" displayName="outcome"/>
          <value xsi:type="CE" code="3" displayName="not recovered/not resolved/ongoing" codeSystem="2.16.840.1.113883.3.989.2.1.1.11"/>
         </observation>
      </outboundRelationship2>
      <outboundRelationship2 typeCode="PERT">
        <observation classCode="OBS" moodCode="EVN">
          <code code="24" displayName="medicalConfirmationByHealthProfessional" codeSystem="2.16.840.1.113883.3.989.2.1.1.19"/>
          <value xsi:type="BL" value="true"/>
        </Observation>
      </outboundRelationship2>
      <outboundRelationship2 typeCode="PERT">
        <observation classCode="OBS" moodCode="EVN">
           <code code="C17649" displayName="Other" codeSystem="2.16.840.1.113883.3.26.1.1"/>
           <value xsi:type="BL" value="true"/>
        </Observation>
      </outboundRelationship2>
    </observation>
  </subjectOf2>
 </primaryRole> 

Validation Procedures

8.1.2.1 There may be several observations that record information that is directly associated with the reaction.

Those observations which are valid for E2B (drug reporting) will be drawn from the ICH designated namespace:2.16.840.1.113883.3.989.2.1.1.19. Additional regional VAERS codes drawn from the EVS namespace: 2.16.840.1.113883.3.26.1.1are used to further differentiate AE outcome treatment information to support other CDC reporting requirements.  In addition to the ICH value set, the additional codes used for VAERS reporting are included in Table 2: Reaction Associated Observations.

Table 2: Reaction Associated Observations

Code Description Code System OID Value Type Card.
30 reactionForTranslation 2.16.840.1.113883.3.989.2.1.1.19 ED 0..1
37 termHighlightedByReporter 2.16.840.1.113883.3.989.2.1.1.19 CE 0..1
34 resultsInDeath 2.16.840.1.113883.3.989.2.1.1.19 BL 1..1
21 isLifeThreatening 2.16.840.1.113883.3.989.2.1.1.19 BL 1..1
33 requiresInpatientHospitalization 2.16.840.1.113883.3.989.2.1.1.19 BL 1..1
35 resultsInPersistentOrSignificantDisability 2.16.840.1.113883.3.989.2.1.1.19 BL 1..1
12 congenitalAnomalyBirthDefect 2.16.840.1.113883.3.989.2.1.1.19 BL 1..1
26 otherMedicallyImportantCondition 2.16.840.1.113883.3.989.2.1.1.19 BL 1..1
24 medicalConfirmationByHealthProfessional 2.16.840.1.113883.3.989.2.1.1.19 BL 0..1
C53513 Emergency Room 2.16.840.1.113883.3.26.1.1 BL 0..1
C16988 Physician Office 2.16.840.1.113883.3.26.1.1 BL 0..1
C50414 Hospitalization Required 2.16.840.1.113883.3.26.1.1 BL 0..1
C102450 Resulted in Prolongation of Hospitalization 2.16.840.1.113883.3.26.1.1 BL 0..1
27 outcome 2.16.840.1.113883.3.989.2.1.1.19 CE 1..1
C17649 Other 2.16.840.1.113883.3.26.1.1 BL 0..1

8.1.2.2 There is an observation to record Results in Death seriousness criteria. (Observation codes = 34).

8.1.2.3 There is an observation to record Life Threatening seriousness criteria. (Observation codes = 21).

8.1.2.4 There is an observation to record Caused / Prolonged Hospitalisation seriousness criteria. (Observation codes = 33).

8.1.2.5 There is an observation to record Disabling / Incapacitating seriousness criteria. (Observation codes = 35).

8.1.2.6 There is an observation to record Congenital Anomaly / Birth Defect seriousness criteria. (Observation codes = 12).

8.1.2.7 There is an observation to record Other Medically Important Condition seriousness criteria. (Observation codes = 26).

8.1.2.8 There is an observation to record the outcome of the reaction. (Observation code = 27).

8.1.2.9 TIME SENSITIVE WARNING: If requiresInpatientHospitalization (observation code = "33") is true and the US is the source country, then either Hospitalization Required (observation code = "C50414") or Resulted in Prolongation of Hospitalization (observation code = "C102450") is present.

8.1.2.10 TIME SENSITIVE WARNING: If requiresInpatientHospitalization (observation code = "33") is true and the US is the source country, then only one of the two observations: Hospitalization Required (observation code = "C50414") and Resulted in Prolongation of Hospitalization (observation code = "C102450") is true.

8.1.2.11 TIME SENSITIVE WARNING: If requiresInpatientHospitalization (observation code = "33") is not true (nullFlavor = "NI"), then Hospitalization Required (observation code = "C50414") and Resulted in Prolongation of Hospitalization (observation code = "C102450") are not present.

8.1.2.12 TIME SENSITIVE WARNING: If requiresInpatientHospitalization (observation code = "33") is true and Hospitalization Required (observation code = "C50414") is omitted or has the nullFlavor "NI", then Resulted in Prolongation of Hospitalization (observation code = "C102450") must be valued with "true".

8.1.2.13 TIME SENSITIVE WARNING: If requiresInpatientHospitalization (observation code = "33") is true and Prolongation of Hospitalization (observation code = "C102450") is omitted or has the nullFlavor "NI", then Hospitalization Required (observation code = "C50414") must be valued with "true".

8.1.2.14 TIME SENSITIVE WARNING: If Hospitalization Required (observation code = "C50414") is true and the US is the source country, then information for the hospital treating the patient is recorded. The null flavor NI is used in case of missing hospital related data.

8.1.2.15 TIME SENSITIVE WARNING: If Hospitalization Required (observation code = "C50414") is not true (nullFlavor = "NI"), then information for the hospital treating the patient is not present.

8.1.2.16 TIME SENSITIVE WARNING: If Hospitalization Required (observation code = "C50414") is true and the US is the source country, then there is an observation performer.

8.1.2.17 TIME SENSITIVE WARNING: If Hospitalization Required (observation code = "C50414") is true and the US is the source country, then there is a represented Organization.

8.1.2.18 TIME SENSITIVE WARNING: If Hospitalization Required (observation code = "C50414") is true and the US is the source country, then there is a hospital name and if unavailable, then the null flavor "NI" can be provided.

8.1.2.19 TIME SENSITIVE WARNING: If Hospitalization Required (observation code = "C50414") is true and the US is the source country, then there is a hospital address containing city and state address parts. And in case unavailability of an address or address component information, the null flavor NI can be provided.

8.1.2.20 TIME SENSITIVE WARNING: If Hospitalization Required (observation code = "C50414") is true and the US is the source country, then there is an observation (observation code = "C102443", description = "Number of Hospitalization Days) to record the number of days of hospitalization. The null flavor NI is used in case of missing hospital related data.

8.1.2.21 TIME SENSITIVE WARNING: If Hospitalization Required (observation code = "C50414") is not true (nullFlavor = "NI"), then information to record the number of days of hospitalization is not present.

8.1.2.22 TIME SENSITIVE WARNING: If Hospitalization Required (observation code = "C50414") is true, then the US is the source country, and observation value is not null, then value type is integer.

8.1.2.23 Code system may be 2.16.840.1.113883.3.989.2.1.1.19.

8.1.2.24 Code system may be 2.16.840.1.113883.3.26.1.1.

8.1.2.25 WARNING: Display name for a reaction associated observation matches the code.

8.1.2.26 Value type for observation is drawn from Table 2: Reaction Associated Observations.

8.1.2.27 If the seriousness criteria (Observation codes = 34, 21, 33, 35, 12, 26, C53513, C16988, C102450) is present then observation value is true, otherwise the nullFlavor NI is valued.

8.1.2.28 TIME SENSITIVE WARNING: If Hospitalization required (observation code = "C50414") is true, then the number of hospitalization days is recorded.

This information is only collected for US based vaccine event reporting, and only if hospitalization is listed as a consequence of the event.

8.1.2.29 If observation is Reaction For Translation, then value records the primary source description in English translation.

8.1.2.30 There is an observation value that records the highlighted term.

8.1.2.31 Code system is 2.16.840.1.113883.3.989.2.1.1.10.

8.1.2.32 If observation records term Highlighted by Reporter then value is either Yes, highlighted by the reporter, NOT serious (1), or No, not highlighted by the reporter, NOT serious (2), or Yes, highlighted by the reporter, SERIOUS (3), or No, not highlighted by the reporter, SERIOUS (4).

8.1.2.33 WARNING: Display name for the value of Term Highlighted by Reporter matches the code.

8.1.2.34 There is an observation value that records outcome of the reaction.

8.1.2.35 Code system is 2.16.840.1.113883.3.989.2.1.1.11.

8.1.2.36 If observation records outcome of reaction then code value is either recovered/resolved (1), or recovering/resolving (2), or not recovered/not resolved/ongoing (3), recovered/resolved with sequelae (4), fatal (5), or unknown (0).

8.1.2.37 WARNING: Display name matches the code.

8.1.2.38 There may be an observation to record some other outcome to be considered serious (code = C17649). If the outcome value of the adverse event is not applicable to the observation values for 34, 21, 33, 35, 12, 26, C53513, C16988, C50414 and C102450, then observation value is true, otherwise the nullFlavor NI is valued.

9 Suspect Product Use

FDA adverse event reporting requires the identification of the substance administrations (e.g., use of a drug or biologic product that are related to the event). As part of the causality assessment (see Section 15Causality Assessment ) each recorded substance administration should be listed as suspect, interacting, or concomitant based on the reporter's estimation of its role. All adverse event reports must contain at least one substance administration. It is expected that detail such as author (responsible or prescribing physician) and performer (healthcare provider such as a nurse, physician assistant, vaccine administrator, etc.) may be provided for the suspect administration. Vaccine adverse events require information about the responsible physician and vaccine administrator is required.

Substance administrations may be recorded for either the investigative subject or other related persons (e.g., family members.)

Some of the more elaborate elements within this structure are included as separate sections.

There is a consumable relationship to record information about the consumable medicinal product. The content of this element is discussed in Section11Product Information.

There may be one or more outbound relationships to record dosage and other substance administration details. The content of this element is discussed in Section10Product Dosage and Administration Details.

9.1 Substance Administration Information

9.1.1 Identification of Substance Administration

<MCCI_IN200100UV01>
... 
  <PORR_IN049016UV>
  ... 
    <component>
      <adverseEventAssessment>
      <subject1>
        <primaryRole>
        <subjectOf2 typeCode="SBJ">
          <organizer classCode="CATEGORY" moodCode="EVN">
          <code code="4"
          codeSystem="2.16.840.1.113883.3.989.2.1.1.20"
          displayName="drugInformation" />
          <component typeCode="COMP">
            <substanceAdministration classCode="SBADM"
            moodCode="EVN">
            <id root="3c91b4d5-e039-4a7a-9c30-67671b0ef9e4" />
            <consumable>
            <outboundRelationship1 typeCode="SAS">
              <pauseQuantity value="10" unit="d" />
              <actReference classCodce="OBS" moodCode="EVN">
              <id root="154eb889-958b-45f2-a02f-42d4d6f4657f" />
              </actReference>
            </outboundRelationship1>... ...</consumable>
            </substanceAdministration>
          </component>
          </organizer>
        </subjectOf2>
        </primaryRole>
      </subject1>
      </adverseEventAssessment>
    </component>
  </PORR_IN049016UV>
</MCCI_IN200100UV01>

Validation Procedures

9.1.1.1 There is an organizer class.

The organizer provides a grouper for information regarding suspect substance administrations.

9.1.1.2 Class code and mood code are as above.

9.1.1.3 Organizer code system is 2.16.840.1.113883.3.989.2.1.1.20

9.1.1.4 There is an organizer code.

9.1.1.5 Organizer code value is as above.

9.1.1.6 There may be one or many substance administrations.

9.1.1.7 Class code and mood code are as above.

9.1.1.8 There is a substance administration ID.

9.1.1.9 WARNING: Substance administration id root is a GUID/UUID.

There is a consumable relationship to record information on the consumable medicinal product. The content of this element is discussed in Section 10 Product Information.

9.1.1.10 The assigned substance administration id uniquely identifies the substance administration within the ICSR.

9.1.1.11 There may be one or more outbound relationships to record the elapsed time between the substance administration and an identified reaction.

9.1.1.12 Type code is either SAS or SAE.

The type code indicates whether the elapsed time is measured from the beginning of the substance administration (SAS), or from the end of the substance administration (SAE).

9.1.1.13 The unit of measure for the pause quantity is a UCUM expression for time duration. Second, minute, hour, week, day, month and year are allowed.

9.1.1.14 WARNING: Act reference id root is GUID/UUID that identifies the associated reaction.

9.1.2 Substance Administration Associated Observation

<primaryRole>
  <subjectOf2 typeCode="SBJ">
    <organizer classCode="CATEGORY" moodCode="EVN">
      <code code="4" codeSystem="2.16.840.1.113883.3.989.2.1.1.20"
      displayName="drugInformation" />
      <component typeCode="COMP">
        <substanceAdministration classCode="SBADM" moodCode="EVN">
          <outboundRelationship2 typeCode="COMP">
            <observation classCode="OBS" moodCode="EVN">
              <code code="6"
              codeSystem="2.16.840.1.113883.3.989.2.1.1.19"
              displayName="blinded" />
              <value xsi:type="BL" value="true" />
            </observation>
          </outboundRelationship2>
          <outboundRelations2 typeCode="COMP"></outboundRelations2>
          <outboundRelationship2 typeCode="SUMM">
            <observation classCode="OBS" moodCode="EVN">
              <code code="14"
              codeSystem="2.16.840.1.113883.3.989.2.1.1.19"
              displayName="cumulativeDoseToReaction" />
              <value xsi:type="PQ" value="10" unit="G.k.5b" />
            </observation>
          </outboundRelationship2>
          <outboundRelationship2 typeCode="PERT">
            <observation classCode="OBS" moodCode="EVN">
              <code code="16"
              codeSystem="2.16.840.1.113883.3.989.2.1.1.19"
              displayName="gestationPeriod" />
              <value xsi:type="PQ" value="10" unit="G.k.6b" />
            </observation>
          </outboundRelationship2>
          <outboundRelationship2 typeCode="PERT">
            <observation classCode="OBS" moodCode="EVN">
              <code code="31"
              codeSystem="2.16.840.1.113883.3.989.2.1.1.19"
              displayName="recurranceOfReaction" />
              <value xsi:type="CE" code="G.k.9.i.4"
              codeSystem="2.16.840.1.113883.3.989.2.1.1.16" />
              <outboundRelationship1 typeCode="REFR">
                <actReference classCode="OBS" moodCode="EVN">
                  <id root="154eb889-958b-45f2-a02f-42d4d6f4657f" />
                </actReference>
              </outboundRelationship1>
            </observation>
          </outboundRelationship2>
          <outboundRelationship2 typeCode="REFR">
            <observation classCode="OBS" moodCode="EVN">
              <code code="9"
              codeSystem="2.16.840.1.113883.3.989.2.1.1.19"
              displayName="codedDrugInformation" />
              <value xsi:type="CE" code="G.k.10.r"
              codeSystem="2.16.840.1.113883.3.989.2.1.1.17" />
              <!-- Additional Information on Drug (coded)(repeat as necessary) #1-2 -->
            </observation>
          </outboundRelationship2>
          <outboundRelationship2 typeCode="REFR">
            <observation classCode="OBS" moodCode="EVN">
              <code code="2"
              codeSystem="2.16.840.1.113883.3.989.2.1.1.19"
              displayName="additionalInformation" />
              <value xsi:type="ST">Somthing seemed strange about
              the way it went down.</value>
              <!-- Additional Information on Drug (free text) #1 -->
            </observation>
          </outboundRelationship2>
          <outboundRelationship2 typeCode="FLFS">
            <sequenceNumber value="3" />
            <substanceAdministration moodCode="INT"
            classCode="SBADM" />
          </outboundRelationship2>
        </substanceAdministration>
      </component>
    </organizer>
  </subjectOf2>
</primaryRole>

Validation Procedures

9.1.2.1 There may be several observations, associated through an out bound relationship, that record information that is directly associated with the substance administration.

Table 3: Substance Administration Associated Observations

Code Description Code System OID Value Type Card.
6 blinded 2.16.840.1.113883.3.989.2.1.1.19 BL 0..1
14 cumulative DoseToReaction 2.16.840.1.113883.3.989.2.1.1.19 PQ 0..1
16 gestationPeriod 2.16.840.1.113883.3.989.2.1.1.19 PQ 0..1
31 recurrenceOfReaction 2.16.840.1.113883.3.989.2.1.1.19 CE 0..*
9 codedDrugInformation 2.16.840.1.113883.3.989.2.1.1.19 CE 0..*
2 AdditionalInformation 2.16.840.1.113883.3.989.2.1.1.19 ST 0..*

The observation on blinding will only be collected for clinical trial reports.

9.1.2.2 There is an observation code whose value is drawn from Table 3: Substance Administration Associated Observations.

9.1.2.3 Code system for observation code is 2.16.840.1.113883.3.989.2.1.1.19.

9.1.2.4 WARNING: Display name for the substance administration associated observation matches the code.

9.1.2.5 Value type for observation value is drawn from Table 3: Substance Administration Associated Observations.

9.1.2.6 If the observation records cumulative dose to reaction (code = "14"), then unit of measure is drawn from the list of UCUM codes documented in Appendix A: Unit of Measure Value Set.

9.1.2.7 If the observation collects gestation period information (observation code = "16"), then the UCUM codes for month, week, day, and trimester are allowed.

9.1.2.8 If the observation collecting blinded information (code = "6") is indicating the substance administration was blinded, then observation value is true, otherwise the observation is not valued.

9.1.2.9 If the observation collects reaction recurrence information (code = "31"), the associated reaction is identified by act reference id.

9.1.2.10 If the observation collects reaction recurrence information (code = "31"),observation code value is either rechallenge was done, reaction recurred (1), or rechallenge was done, reaction did not recur (2), or rechallenge was done, outcome unknown (3) or no rechallenge was done, recurrence is not applicable (4).

9.1.2.11 Code system for recurrence of Reaction value is 2.16.840.1.113883.3.989.2.1.1.16.

9.1.2.12 WARNING: Display name for the recurrence of reaction information matches the code.

9.1.2.13 Act reference id root is a GUID/UUID that identifies the associated reaction.

9.1.2.14 The act reference id root matches a GUID assigned to a recorded reaction.

9.1.2.15 There is no more than one reaction recurrence observation related to the substance administration for each recorded reaction.

9.1.2.16 If the observation collects coded drug information, the code system for observation value is 2.16.840.1.113883.3.989.2.1.1.17.

9.1.2.17 If the observation collects coded drug information, observation value comes fromTable 4: Substance Administration Additional Information.

Table 4: Substance Administration Additional Information.

Code/ Description Code System OID
1 Counterfeit 2.16.840.1.113883.3.989.2.1.1.17
2 Overdose 2.16.840.1.113883.3.989.2.1.1.17
3 Drug taken by the father 2.16.840.1.113883.3.989.2.1.1.17
4 Drug taken beyond expiry date 2.16.840.1.113883.3.989.2.1.1.17
5 Batch and lot tested and found within specifications 2.16.840.1.113883.3.989.2.1.1.17
6 Batch and lot tested and found not within specifications 2.16.840.1.113883.3.989.2.1.1.17
7 Medication error 2.16.840.1.113883.3.989.2.1.1.17
8 Misuse 2.16.840.1.113883.3.989.2.1.1.17
9 Abuse 2.16.840.1.113883.3.989.2.1.1.17
10 Occupational exposure 2.16.840.1.113883.3.989.2.1.1.17
11 Off label use 2.16.840.1.113883.3.989.2.1.1.17

9.1.2.18 WARNING: Display name for the substance administration additional information matches the code.

9.1.2.19 There may be information to record the vaccine dose in series for a substance administration.

Dose in series is only recorded for US based vaccine reporting. A vaccine may be ordered as a series of doses - required in order to achieve the desired effect. The dose in series is recorded as the sequence within a larger scale substance administration act.

9.1.2.20 There is an outbound relationship sequence number.

9.1.2.21 Mood code for substance administration is as above.

9.1.3 Inbound Relationship

<primaryRole>
  <subjectOf2 typeCode="SBJ">
    <organizer classCode="CATEGORY" moodCode="EVN">
      <code code="4" codeSystem="2.16.840.1.113883.3.989.2.1.1.20" 
      displayName="drugInformation" />
        <component typeCode="COMP">
          <substanceAdministration classCode="SBADM" moodCode="EVN">
            <inboundRelationship typeCode="RSON">
              <observation classCode="OBS" moodCode="EVN">
                <code code="19" displayName="indication"
                codeSystem="2.16.840.1.113883.3.989.2.1.1.19" />
                <value xsi:type="CE" code="G.k.7.r.2b"
                 codeSystem="2.16.840.1.113883.6.163"
                 codeSystemVersion="G.k.7.r.2a">
                    <originalText>G.k.7.r.1</originalText>
                </value>
                <performer typeCode="PRF">
                   <assignedEntity classCode="ASSIGNED">
                      <code code="3" displayName="sourceReporter"
                      codeSystem="2.16.840.1.113883.3.989.2.1.1.21">
                        <inboundRelationship typeCode="CAUS">
                            <act classCode="ACT" moodCode="EVN">
                                <code code="2" displayName="dose Reduced"
                                codeSystem="2.16.840.1.113883.3.989.2.1.1.15" />
                            </act>
                        </inboundRelationship>
                        <inboundRelationship typeCode="REFR">
                            <substanceAdministration classCode="SBADM"
                             moodCode="EVN">
                                <repeatNumber>
                                    <low value="2" />
                                    <high value="2" />
                                </repeatNumber>
                            </substanceAdministration>
                        </inboundRelationship>
                      </code>
                    </assignedEntity>
                </performer>
              </observation>
            </inboundRelationship>
          </substanceAdministration>
        </component>
      </organizer>
   </subjectOf2>
</primaryRole>

Validation Procedures

9.1.3.1 There may be one or more observations (observation code = "19") to record the indication for the substance administration.

9.1.3.2 Class code and mood code are as above.

9.1.3.3 Code system for observation code is 2.16.840.1.113883.3.989.2.1.1.19.

9.1.3.4 WARNING: Display name "indication" matches the code.

9.1.3.5 Value type for observation value is "CE".

9.1.3.6 If there is no observation information, then null flavors ASKU, NASK, UNK are allowed.

9.1.3.7 If indication information is recorded as code, then Code system is 2.16.840.1.113883.6.163 (MedDra).

9.1.3.8 If indication information is recorded as code, code system version is collected.

9.1.3.9 There may be original text item containing a text record of the indication.

9.1.3.10 There is performer participation.

Indicate that the entity responsible for the indication information is the source reporter. Class code is as above.

9.1.3.11 Assigned entity code is 3.

9.1.3.12 Assigned entity code system is 2.16.840.1.113883.3.989.2.1.1.21.

9.1.3.13 WARNING: Display name "sourceReporter" matches the code.

9.1.3.14 WARNING: Display name matches the code.

9.1.3.15 There may be an act that records the activity taken.

9.1.3.16 Class code and mood code are as above.

9.1.3.17 Code system is 2.16.840.1.113883.3.989.2.1.1.15.

9.1.3.18 Act code value is either Drug withdrawn (1), or Dose reduced (2), or Dose increased (3), or Dose not changed (4), or Unknown (0), or Not applicable (9).

9.1.3.19 WARNING: Display name for the action taken with the drug matches the code.

9.1.3.20 There may be a substance administration that records the number of previous doses of the substance.

Number of repeat dose information is only collected for US vaccine reporting.

9.1.3.21 Substance administration repeat number records the number of previous doses.

10 Product Dosage and Administration Details

Medicinal product dose and administration details are captured using the substance administration structure. Dose therapy regimens that change or are adjusted over time are handled as a separate dose or administration component of the primary substance administration act.

This section contains:

The information that may vary within the context of a subject's use of a given medicinal product.

The more detailed administration information that is relevant for US vaccine reporting.

10.1 Substance Administration Structure

10.1.1 Substance Administrative Basic Details

<MCCI_IN200100UV01>
  <PORR_IN049016UV>
    <subjectOf2>
      <organizer>
        <code code="4"
        codeSystem="2.16.840.1.113883.3.989.2.1.1.20"
        displayName="drugInformation"/>
        <component>
          <substanceAdministration>
            <outboundRelationship2 typeCode="COMP">
              <substanceAdministration classCode="SBADM"
              moodCode="EVN">
                <text>unstructured dosing information, e.g. take by
                mouth 2 times a day with food</text>
                <effectiveTime xsi:type="SXPR_TS">
                  <comp xsi:type="IVL_TS" operator="A">
                    <low value="20090101"/>
                    <width value="20090101"/>
                  </comp>
                  <comp xsi:type="IVL_TS" operator="A">
                    <low value="20090101"/>
                  </comp>
                </effectiveTime>
                <approachSiteCode code="C12421"
                codeSystem="2.16.840.1.113883.3.26.1.1"/>
                <routeCode code="C38288"
                codeSystem="2.16.840.1.113883.3.26.1.1">
                  <originalText>Free text route
                  content</originalText>
                </routeCode>
                <doseQuantity value="10" unit="mg"/>
                <consumable typeCode="CSM">
                  <instanceOfKind classCode="INST">
                    <productInstanceInstance classCode="MMAT"
                    determinerCode="INSTANCE">
                      <lotNumberText>G.k.4.r.7</lotNumberText>
                    </productInstanceInstance>
                    <kindOfProduct classCode="MMAT"
                    determineCode="KIND">
                      <formCode code="C42998" displayName="tablet"
                      codeSystem="2.16.840.1.113883.3.26.1.1">
                        <originalText>Big, round and colored
                        white</originalText>
                      </formCode>
                    </kindOfProduct>
                  </instanceOfKind>
                </consumable>
              </substanceAdministration>
            </outboundRelationship2>
          </substanceAdministration>
        </component>
      </organizer>
    </subjectOf2>
  </PORR_IN049016UV>
</MCCI_IN200100UV01>

Validation Procedures

10.1.1.1 There is a substance administration that records dosage and route information. They may be more than one.

10.1.1.2 Class code and mood code are as above.

10.1.1.3 There may be a text entry.

The entry contains information related to the particular set of substance administrations.

10.1.1.4 There may be an effective time.

The level of precision provided will vary depending on the data to be conveyed .The effective time is a collection of time intervals to allow for the unusual situation in which start and stop times and duration are collected for a substance administration for the substance administration.

10.1.1.5 If a null flavor is provided for an optional effective time component, then the following null flavors MSK, ASKU, NASK are allowed.

10.1.1.6 The effective time data type is either SXPR_TS, IVL_TS or PIVL_TS.

10.1.1.7 If data type is SXPR_TS, there may be a component with data type PIVL_TS.

10.1.1.8 If present, within a PIVL component, the unit of measure is a UCUM time interval. UCUM codes for second, minute, hour, week, day, month and year are allowed. In addition, the exceptional values: cyclical, asnecessary and total can be used.

10.1.1.9 There is a component with data type IVL_TS. The two components are intersecting.

10.1.1.10 If present, within IVL duration, the unit of measure is a UCUM time interval. UCUM codes for second, minute, hour, week, day, month and year are allowed.

10.1.1.11 Only two of start date/time, stop date/time and duration may be valued.

10.1.1.12 There may be a approach site information. If there is no specific approach site, then null flavors UNK, ASKU, NI may be used to indicate missing information.

Approach site code information is only collected for US vaccine reporting.

10.1.1.13 Code system is 2.16.840.1.113883.3.26.1.1 for approach site code.

10.1.1.14 If not null, approach site code is drawn from Table 6: Vaccination Site on Body ICSR Terminology.

Table 6: Vaccination Site on Body ICSR Terminology

Code Display Name
C105633 Left Arm
C105636 Left Gluteus Medius
C105634 Left Deltoid
C105642 Left Lower Forearm
C105632 Left Thigh
C105640 Left Vastus Lateralis
C105636 Right Arm
C105635 Right Deltoid
C105639 Right Gluteus Medius
C105643 Right Lower Forearm
C105637 Right Thigh
C105641 Right Vastus Lateralis
C32141 Arm
C33763 Thigh
C89806 Buttock

10.1.1.15 WARNING: If not null, display name will match the Vaccination Site on Body ICSR Terminology code.

10.1.1.16 There may be a route. If there is no specific route information, then null flavorsASKU, NASK, UNK may be used to indicate missing information.

10.1.1.17 There may be a route code.

10.1.1.18 If there is a code, then code system version is provided.

10.1.1.19 If code is provided, then code system is either 2.16.840.1.113883.3.26.1.1or 2.16.840.1.113883.3.989.2.1.1.14 for route code.

This may be coded or supplied as text. The value set to be used - Route of Administration - is drawn from the NCI Thesaurus.

10.1.1.20 WARNING: Display name for route information matches the code.

10.1.1.21 Original text may be supplied for the route.

10.1.1.22 The route includes either code, original text, or null flavor.

10.1.1.23 There may be dose quantity value.

10.1.1.24 If there is a dose quantity, then there is a dose quantity unit.

10.1.1.25 There may be dose quantity unit.

10.1.1.26 If dosing information is provided, then dose unit comes from the list of UCUM codes documented in Appendix A: Unit of Measure Value Set. Note that the exceptional value DF can be used.

10.1.1.27 There may be consumable product information.

10.1.1.28 If lot number is present then it is collected as text.

10.1.1.29 There may be a dosage form.The null flavors ASKU, NASK, UNK show the unavailability of information.

10.1.1.30 There may be a dose form.

10.1.1.31 If dose form code is present, then code system is 2.16.840.1.113883.3.26.1.1.

10.1.1.32 If there is a code, then code system version is provided.

10.1.1.33 WARNING: Display name for dosage form matches the code.

10.1.1.34 Dose form information may be collected as original text.

10.1.2 Performer Details and Author Information

<substanceAdministration>
    <outboundRelationship2 typeCode="COMP">
        <substanceAdministration classCode="SBADM" moodCode="EVN">
            <performer typeCode="PRF">
                <assignedEntity classCode="ASSIGNED"/>
                    <code code="C16988" displayName="Physician office"
                          codeSystem="2.16.840.1.113883.3.26.1.1"/>
                    <representedOrganization classCode="ORG"
                      determinerCode="INSTANCE">
                        <telecom value="tel:6667778888"/>
                        <telecom value="fax:9991112222"/>
                        <addr>
                        <streetAddressLine>33 Main St</streetAddressLine>
                        <city>Pleasantville</city>
                        <state>California</state>
                        <postalCode>99999-4444</postalCode>
                        <country>US</country>
                        </addr>
                    </representedOrganization>
            </performer>
            <author typeCode="AUT">
                <assignedEntity classCode="ASSIGNED"/>
                    <assignedPerson classCode="PSN"
                  determinerCode="INSTANCE"/>
                        <name>
                            <prefix nullFlavor="NI">
                            <given>Joseph</given>
                            <given nullFlavor="NI">
                            <family>Rabinowitz</family>
                        </name>    
                        <telecom value="tel:9874562222"/>
                        <telecom value="mailto:email@address.com"/>
                        <addr>
                            <streetAddressLine>24 Main St.</streetAddressLine>
                            <streetAddressLine>Suite 2304</streetAddressLine>
                            <city>Metropolis</city>
                            <state>Northside</state>
                            <postalCode>123245</postalCode>
                        </addr>
            </author>
        </substanceAdministration>
    </outboundRelationship2>
</substanceAdministration>

Validation Procedures

Performer is not collected for ICH medicinal product reporting, but it is collected - if available - for vaccine administrations in vaccine AE reports.

Information for the facility responsible for the vaccination is captured as the responsible facility for the vaccination performance. The full county name should be entered in VAERS Box 2, when known, for all U.S. vaccine reports. When the full county name is entered without a county code, then the state must also be entered in VAERS Box 1 because many counties are not uniquely named across the U.S. states. When a county code is used, one should use the format that is described in sections 4.6 and 4.7 of the American National Standards Institute (ANSI) International Committee for Information Technology Standards (INCITS) specification standard 31-2009, which is entitled, "Codes for the Identification of Counties and Equivalent Areas of the United States, Puerto Rico, and the Insular Areas". 

10.1.2.1 Type code of performer is as above.

10.1.2.2 TIME SENSITIVE WARNING: There can be a performer for the substance administration. The performer is required for the initial substance administration for US source reports.

10.1.2.3 If performer information is provided, and if it is a US source report, there is a name for performing facility and if unavailable, then the null flavor "NI" is provided.

10.1.2.4 If performer information is provided, and if it is a US source report, there is an address for performing facility. The address includes an address line, city, state, postal code and country and if unavailable, then the null flavor "NI" is provided.

10.1.2.5 If performer information is provided, and if it is a US source report, there is a telephone number for performing facility report and if unavailable, then the null flavor "NI" is provided.

10.1.2.6 If performer information is provided, and if it is a US source report,there is a fax number for performing facility and if unavailable, then the null flavor "NI" is provided.

10.1.2.7 If there are multiple substance administrations with the same date as recorded by substance administration effective time, then there is performer information for the initial substance administration or there may be performer information for administrations beyond the initial one.

10.1.2.8 There is an assigned entity code.

10.1.2.9 Assigned entity code value is either Physician Office (C16988), Hospital (C16696), Clinic (C51282), Public Health Department (C114860), Workplace Clinic (C114861), Student Health Clinic (C114862), Pharmacy (C114863), Nursing Home (C53533), Long-Term Care for Elderly (C16801. The null flavors OTH or UNK can be used to indicate lack of information.

10.1.2.10 WARNING: Display name for the administration performer type matches the code.

10.1.2.11 If a non-null code value is provided, then code system is 2.16.840.1.113883.3.26.1.1.

10.1.2.12 There is a represented organization. Class code and determiner code are as above.

10.1.2.13 There is a facility name and if unavailable or no US source report, then the nullFlavor "NI" can be used.

10.1.2.14 There is a facility telephone number and if unavailable or no US source report, then the nullFlavor "NI" can be used.

10.1.2.15 There is a facility fax number and if unavailable or no US source report, then the nullFlavor "NI" can be used.

10.1.2.16 Telecom value begins with either tel: or mailto: or fax: unless a null flavor is provided and if no US source report, then the nullFlavor "NI" can be used.

10.1.2.17 There is an address for the performing facility. The address has street address line (which may repeat one time), city, state, postalcode and country and if unavailable or no US source report, then the nullFlavor "NI" can be used.

10.1.2.18 If state information is unavailable or if the report is not a US source report, then the nullFlavor "NI" can be used.

10.1.2.19 The country value is drawn from ISO 3166-1 alpha 2, with the addition that the value "EU may be used.

10.1.2.20 If country information is unavailable or if the report is not a US source report, then the nullFlavor "NI" can be used.

10.1.2.21 There may be one or more telecommunications addresses. If unavailable or if the report is not a US source report, the nullFlavor "NI" can be used.

10.1.2.22 There may be a substance administration ordering clinician.

Ordering clinician is not collected for ICH medicinal product reporting but it is collected - if available - for vaccine administrations in vaccine AE reports.

10.1.2.23 There may be an author name.

10.1.2.24 There may be an author telephone number.

10.1.2.25 There may be an author email address.

10.1.2.26 Type code of author is as above.

10.1.3 Location and Inbound Information

<substanceAdministration>
    <outboundRelationship2 typeCode="COMP">
        <substanceAdministration classCode="SBADM" moodCode="EVN">
            <inboundRelationship typeCode="REFR">
                <observation classCode="OBS" moodCode="EVN">
                    <code code="28"
                              codeSystem="2.16.840.1.113883.3.989.2.1.1.19"
                              displayName="parentRouteOfAdministration"/>
                    <value xsi:type="CE" code="C12421"
                              codeSystem="2.16.840.1.113883.3.26.1.1">
                    <originalText>Text to describe the route if
                                needed</originalText>
                    </value>
                </observation>
            </inboundRelationship>
        </substanceAdministration>
    </outboundRelationship2>
</substanceAdministration>

Validation Procedures

10.1.3.1 There may be an inbound relationship that captures the known route of administration of the drug as taken by the parent. The information is recorded as an observation.

Parent route information is only relevant when the person experiencing the reaction is different from the one the substance was administered to.

10.1.3.2 Observation code is 28.

10.1.3.3 WARNING: Display name "parentRouteOfAdministration" matches the code.

10.1.3.4 Code system is 2.16.840.1.113883.3.989.2.1.1.19.

10.1.3.5 If the parent route information is unavailable,then the null flavors ASKU, NASK, UNK show the unavailability of information.

10.1.3.6 The observation value may include a code value drawn from the Route of Administration value set.

10.1.3.7 If parent route of administration is available, then code system for observation value is 2.16.840.1.113883.3.26.1.1.

10.1.3.8 If there is a code, then there is a code system version.

The value set to be used - Route of Administration - is drawn from the NCI Thesaurus.

10.1.3.9 Original text may be used to provide text information regarding the route.

10.1.3.10 There is an observation recording Vaccination at Military Site information (Observation Code = C114865) recorded for the initial substance administration.

10.1.3.11 If there is more than one substance administration, then there may be an observation recording Vaccination at Military Site information (Observation Code = C114865) recorded for substance administrations beyond the initial one.

10.1.3.12 Code system for observation code is 2.16.840.1.113883.3.26.1.1.

10.1.3.13 Value type for observation value is "BL.

10.1.3.14 If there is no observation information, then null flavor NI is allowed.

11 Product Information

ICSRs capture information about the investigation into an event associated with the use of a product. The product may be consumed through a substance administration or used in the context of a procedure, e.g., a medical device. In either case, information is collected for the specific product instance, and for the type of product involved. Note, however, that the key product instance information is recorded within the context of the product's dosage details.

11.1 Drug(s) and Substance Administration Information

11.1.1 Code and Name

<consumable typeCode="CSM">
  <instanceOfKind classCode="INST">
    <kindOfProduct classCode="MMAT" determinerCode="KIND">
      <code code="345507" codeSystem="2.16.840.1.113883.6.69"/>
      <name>CureAll</name>
      <asEntityWithGeneric classCode="GRIC">
      <genericMedicine classCode=MMAT" determinerCode="KIND">
        <name>US generic name</name>
      </genericMedicine>
     </asEntityWithGeneric>

Validation Procedures

11.1.1.1 Consumable type code, instance of kind class code, kind of product class code and determiner code are as above.

11.1.1.2 WARNING: There is a product code.

11.1.1.3 TIME SENSITIVE WARNING: If there is a product code, and if the US is the source country, then product code is an NDC/NHRIC code, as indicated by codeSystem = 2.16.840.1.113883.6.69.

11.1.1.4 If there is a product code and it is a US source report, then the code (NDC/NHRIC product code) has at least two segments separated by a hyphen. It may have a third segment which is also separated by a hyphen.

11.1.1.5 TIME SENSITIVE WARNING: If there is a product code, then code system and code system version is valued.

There may be manufacturer information provided for suspect, concomitant and interacting. The content of this element is discussed in Section 0Error! Not a valid bookmark self-reference.

11.1.1.6 There may be a generic medicine information.

Generic name information is required if the product is a vaccine, and if it is a non-US based report in which the local name for the vaccine is provided as the product name.

11.1.1.7 If there is a product code and it is a US source report, then code system version is a time stamp in the form CCYYMMDDHHMMSS. It indicates the date/time a reference file was downloaded from FDA. Date/time must be provided with at least the precision of year.

11.1.1.8 There is a medicinal product name, recorded as the product name.

11.1.1.9 If (and only if) generic medicine information is provided, then role class code, entity class code, and entity determiner code are as above.

11.1.1.10 There is a generic medicine name.

11.1.2 Marketing Authorization Information

This section identifies the organization which holds marketing authorization for the product. For vaccines, manufacturer information is provided as marketing authorization holder information. This information is collected in ICH E2B (R3) as the applicant or marketing authorization holder (G.k.3.3 Name of Holder/Applicant). For US vaccine reporting, this information is captured for suspect vaccines and for Vaccines Given within 4 Weeks

<consumable typeCode="CSM">
  <instanceOfKind classCode="INST">
    <kindOfProduct classCode="MMAT" determinerCode="KIND">
      <asManufacturedProduct classCode="MANU">
        <subjectOf typeCode="SBJ">
          <approval classCode="CNTRCT" moodCode="EVN">
            <id extension="NDA123456"
            root="2.16.840.1.113883.3.989.2.1.3.4" />
            <holder typeCode="HLD">
              <role classCode="HLD">
                <playingOrganization classCode="ORG"
                determinerCode="INSTANCE">
                  <name>Big Pharma</name>
                </playingOrganization>
              </role>
            </holder>
            <author typeCode="AUT">
              <territorialAuthority classCode="TERR">
                <territory classCode="NAT"
                determinerCode="INSTANCE">
                  <code code="US" codeSystem="1.0.3166.1.2.2" />
                </territory>
              </territorialAuthority>
            </author>
          </approval>
        </subjectOf>

Validation Procedures

11.1.2.1 There may be regional marketing authorization information about the medicinal product.

11.1.2.2 If a report refers to a serious adverse event (observation value = "True", where observation code ="23" (localCriteriaForExpedited)), then marketing authorization information is present.

11.1.2.3 There can be an id extension that records the license authorization identifier or application number.

11.1.2.4 WARNING: Id root is valued with 2.16.840.1.113883.3.989.2.1.3.4.

11.1.2.5 If present, the application number is a string value.

FDA requires the use of a prefix to determine the application type associated with primary suspect products. For eVAERS reporting, the prefix used is "BLA". In order to address the wide range of possible authorization numbers, a non-specific string will also be accepted.

11.1.2.6 WARNING: For US source reports, if present, the application number must follow FDA format. It has a BLA prefix followed directly by 6 digits without space or NDA or ANDA prefixes followed by up to 25 digits without a space.

11.1.2.7 WARNING: For US source reports, there must be at least one application number recorded for the consumable products associated with the substance administrations within the Product Use section.

11.1.2.8 If it is a US source report, and there is an application number for the consumable product associated with the first substance administration within the Product Use section, then the application number has a BLA prefix followed directly by 6 digits without space.

11.1.2.9 WARNING: For US source reports only, for reports with no BLA prefixed authorization numbers, all consumable product associated with substance administrations within the Product Use section must have the authorization number valued.

11.1.2.10 If marketing authorization number is provided, then there is a name for the regional marketing authorization holder.

11.1.2.11 If marketing authorization number is provided, then the territorial authority of the marketing authorization is included.

11.1.2.12 Type code, class code, and determiner code are as above.

11.1.2.13 Code system is 1.0.3166.1.2.2.

11.1.2.14 If a non-null value is provided, then country code comes from the ISO alpha 2 country code list, with the addition that the value "EU may be used.

11.1.3 Characteristics

<consumable typeCode="CSM">
  <instanceOfKind classCode="INST">
    <kindOfProduct classCode="MMAT" determinerCode="KIND">
      <asManufacturedProduct classCode="MANU">
        <subjectOf typeCode="SBJ">
          <characteristic classCode="OBS" moodCode="EVN">
            <code code="C94031" displayName="Product Type Code"
            codeSystem="2.16.840.1.113883.3.26.1.1" />
            <value xsi:type="CV" code="C73626" displayName="Bulk ingredient" codeSystem="2.16.840.1.113883.3.26.1.1"/>
          </characteristic>
        </subjectOf>

Validation Procedures

11.1.3.1 There can be at most one observation conveying combination product or compounded product information. Code value is Product Type Code (C94031).

11.1.3.2 Value code system is 2.16.840.1.113883.3.26.1.1.

11.1.3.3 Product Type value is drawn from Table 7.

Table 7: Product Type Information

Code Display Name
C102834 Type 1: Convenience Kit of Co-Package
C102835 Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
C102836 Type 3: Prefilled Biologic Delivery Device/System (syringe, patch, etc.)
C102837 Type 4: Device Coated/Impregnated/Otherwise Combined with Drug
C102838 Type 5: Device Coated or Otherwise Combined with Biologic
C102839 Type 6: Drug/Biologic Combination
C102840 Type 7: Separate Products Requiring Cross Labeling
C102841 Type 8: Possible Combination Based on Cross Labeling of Separate Products (Temporary Type)
C102842 Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
C73626 Bulk ingredient
C96793 Bulk Ingredient For Human Prescription Compounding
C95602 Unapproved Drug Product Manufactured Exclusively for Private Label Distributor

11.1.3.4 WARNING: Display name for the product type information matches the code.

11.1.3.5 Characteristic value type is CE.

11.1.4 Ingredient

<consumable typeCode="CSM">
  <instanceOfKind classCode="INST">
    <kindOfProduct classCode="MMAT" determinerCode="KIND">
      <ingredient classCode="ACTI">
        <quantity>
          <numerator value="10" unit="G.k.2.3.r.3b"/>
          <denominator value="1"/>
        </quantity>
        <ingredientSubstance classCode="MMAT"
        determinerCode="KIND">
          <code code="012C11ZU6G"
          codeSystem="2.16.840.1.113883.4.9"/>
          <name>Notabenazine Hydrochloride</name>
        </ingredientSubstance>
      </ingredient>

Validation Procedures

11.1.4.1 If the source country is US, and if consumed product code is not provided as the code value identifying the drug, then ingredient information (either name or code) is required.

11.1.4.2 There is a class code.

11.1.4.3 There may be a strength with a numerator and denominator.

11.1.4.4 Numerator and denominator have a value greater than zero and a unit, except the numerator when the ingredient class code is "CNTM".

11.1.4.5 Numerator value includes unit of measure.

11.1.4.6 Unit of measure comes from the list of UCUM codes documented in Appendix A: Unit of Measure Value Set.

11.1.4.7 For percentages numerator unit is not 1, instead use a volume unit for volume fractions and a mass unit for mass fractions.

11.1.4.8 The denominator values and units for all ingredients in this product are the same.

11.1.4.9 There may be an ingredient code with code, code system and code system version.

11.1.4.10 Ingredient code code system is 2.16.840.1.113883.4.9.

11.1.4.11 Ingredient code code system version is valued.

11.1.4.12 The same ingredient substance code is not used more than once per product.

11.1.4.13 There may be an ingredient name.

11.1.4.14 Either ingredient code or ingredient name is provided.

11.1.4.15 If name and code both are provided, then name matches the code.

11.2 Product Event Information

<consumable typeCode="CSM">
  <instanceOfKind classCode="INST">
    <subjectOf typeCode="SBJ">
      <productEvent classCode="ACT" moodCode="EVN">
        <code code="1"
        codeSystem="2.16.840.1.113883.3.989.2.1.1.18"
        displayName="retailSupply" />
        <performer typeCode="PRF">
          <assignedEntity classCode="ASSIGNED">
            <representedOrganization classCode="ORG"
            determinerCode="INSTANCE">
              <addr>
                <country>US</country>
                <!--  Identification of the Country Where the Drug Was Obtained #1 -->
              </addr>
            </representedOrganization>
          </assignedEntity>
        </performer>
      </productEvent>
    </subjectOf>
  </instanceOfKind>
</consumable>

Validation Procedures

11.2.1.1 There may be product event information that records the country where the drug or other substance was obtained.

11.2.1.2 Subject type code and product event class code and mood code are as above.

11.2.1.3 Act code is 1.

11.2.1.4 WARNING: Display name is "retailSupply".

11.2.1.5 Code system is 2.16.840.1.113883.3.989.2.1.1.18.

11.2.1.6 There is a represented organization.

11.2.1.7 Performer type code, assigned entity class code, and represented organization class code and determiner code are as above.

11.2.1.8 There is an address identifying the country where the drug was obtained. Country code comes from the ISO alpha 2 countrycode list. Other address content can be omitted.

12 Investigation Subject Clinical History

A variety of relevant clinical information may be captured for the ICSR subject (patient). Examples include, patient demographics, clinical observations, past medication use and reactions, family medical history and concomitant therapies. Information may be provided using free text or controlled terminology such as MedDRA, and may also include start/end dates. A series of component inbound and outbound relationships are used to capture comments and other Boolean designations about whether a condition is continuing or captured as family history.

12.1 Investigation Subject Details

This section addresses additional information collected for the investigation subject.

There is an organizer that includes information on relevant medical history details. The content of this element is discussed in Section 12.2 Relevant Medical History Details.

There is an organizer that includes information on relevant substance administrations. The content of this element is discussed in Section 12.3 Relevant Drug Details.

There may be an organizer that includes information regarding the subject's vaccination history. This organizer is only relevant for US based vaccine event reporting. The content of this element is discussed in Section 12.4 Relevant Vaccine History Details.

There is an organizer that includes information on relevant tests and procedures. The content of this element is discussed in Section 12.5 Relevant Tests & Procedures.

12.1.1 Organizer

<MCCI_IN200100UV01>
...
    <PORR_IN049016UV>
    ...
        <controlActProcess>
       ...
        <component>
            <adverseEventAssessment>
                <subject1 typeCode="SBJ">
                    <primaryRole classCode="INVSBJ">
                        <subjectOf2 typeCode="SBJ">
                            <observation classCode="OBS" moodCode="EVN">
                                <code code="3" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" displayName="age at onset of reaction"/>
                                <value xsi:type="PQ" value="10" unit="a"/>
                            </observation>
                        </subjectOf2>
                        <subjectOf2 typeCode="SBJ">
                            <observation classCode="OBS" moodCode="EVN">
                                <code code="C103173" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="Age at Time of Vaccination"/>
                                <value xsi:type="PQ" value="10" unit="a"/>
                            </observation>
                        </subjectOf2>
                        <subjectOf2 typeCode="SBJ">
                            <observation classCode="OBS" moodCode="EVN">
                                <code code="16" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" displayName="gestationPeriod"/>
                                <value xsi:type="PQ" value="10" unit="D.2.2.1b"/>
                            </observation>
                        </subjectOf2>
                        <subjectOf2 typeCode="SBJ">
                            <observation classCode="OBS" moodCode="EVN">
                                <code code="4" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" displayName="ageGroup"/>
                                <value xsi:type="CE" code="D.2.3" codeSystem="2.16.840.1.113883.3.989.2.1.1.9"/>
                            </observation>
                        </subjectOf2>
                        <subjectOf2 typeCode="SBJ">
                            <observation classCode="OBS" moodCode="EVN">
                                <code code="7" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" displayName="bodyWeight"/>
                                <value xsi:type="PQ" value="48.2" unit="kg"/>
                            </observation>
                        </subjectOf2>
                        <subjectOf2 typeCode="SBJ">
                            <observation classCode="OBS" moodCode="EVN">
                                <code code="17" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" displayName="height"/>
                                <value xsi:type="PQ" value="152" unit="cm"/>
                            </observation>
                        </subjectOf2>
                        <subjectOf2 typeCode="SBJ">
                            <observation classCode="OBS" moodCode="EVN">
                                <code code="22" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" displayName="lastMenstrualPeriodDate"/>
                                <value xsi:type="TS" value="20090101"/>
                            </observation>
                        </subjectOf2>
                        <subjectOf2 typeCode="SBJ">
                            <observation classCode="OBS" moodCode="EVN">
                                <code code="C76325" displayName="birthWeight" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                                <value xsi:type="PQ" value="400" unit="gm"/>
                            </observation>
                        </subjectOf2>
                        <subjectOf2 typeCode="SBJ">
                            <observation classCode="OBS" moodCode="EVN">
                                <code code="C102469" displayName="numberOfSiblings" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                                <value xsi:type="INT" value="2"/>
                            </observation>
                        </subjectOf2>
                        <subjectOf2 typeCode="SBJ">
                            <observation classCode="OBS" moodCode="EVN">
                                <code code="C17049" displayName="Race" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                                <value xsi:type="CE" code="C41260" displayName="Asian" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                            </observation>
                        </subjectOf2>
                        <subjectOf2 typeCode="SBJ">
                            <observation classCode="OBS" moodCode="EVN">
                                <code code="C16564" displayName="ethnicGroup" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                                <value xsi:type="CE" code="C174595" displayName="Hispanic or Latino" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                            </observation>
                        </subjectOf2>
                        <subjectOf2 typeCode="SBJ">
                            <observation classCode="OBS" moodCode="EVN">
                                <code code="C114855" displayName="Military Status ICSR Terminology" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                                <value xsi:type="CE" code="C114857" displayName="Reserve" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                            </observation>
                        </subjectOf2>
                        <subjectOf2 typeCode="SBJ">
                            <observation classCode="OBS" moodCode="EVN">
                                <code code="C102468" displayName="illnessAtTimeOfVaccination" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                                <value xsi:type="CE" code="87442323" codeSystem="2.16.840.1.113883.6.163" codeSystemVersion="12.0"/>
                            </observation>
                        </subjectOf2>
                        <subjectOf2 typeCode="SBJ">
                            <observation classCode="OBS" moodCode="EVN">
                                <code code="32" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" displayName="reportedCauseOfDeath"/>
                                <value xsi:type="CE" code="D.9.2.r.1b" codeSystem="2.16.840.1.113883.6.163" codeSystemVersion="12.1">
                                <originalText>D.9.2.r.2</originalText>
                                </value>
                            </observation>
                        </subjectOf2>
                        <subjectOf2 typeCode="SBJ">
                            <observation classCode="OBS" moodCode="EVN">
                            <code code="5" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" displayName="autopsy"/>
                            <value xsi:type="BL" value="true"/>
                            <outboundRelationship2 typeCode="DRIV">
                                <observation classCode="OBS" moodCode="EVN">
                                    <code code="8" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" displayName="causeOfDeath"/>
                                    <value xsi:type="CE" code="87654321" codeSystem="2.16.840.1.113883.6.163" codeSystemVersion="12.1">    
                                    <originalText>What we learned during the autopsy</originalText>
                                    </value>
                                </observation>
                            </outboundRelationship2>
                            </observation>
                        </subjectOf2>
                    </primaryRole>
                </subject1>
            </adverseEventAssessment>
        </component>
        ...
        </controlActProcess>
    ...   
    </PORR_IN049016UV>
...
</MCCI_IN200100UV01>

Validation Procedures

12.1.1.1 If the patient has died as indicated by recording date of death, then observation of whether or not an autopsy occurred is recorded. If unavailable, null flavors ASKU, NASK, UNK indicate missing information.

12.1.1.2 There is one or more observations recording Race. If unavailable, null flavors UNK, MSK, OTH indicate missing or unavailable information.

12.1.1.3 There is an observation recording Ethnic Group.If unavailable, null flavors UNK, MSK, NI indicate missing or unavailable information.

12.1.1.4 There may be one to many observations that record information that is relevant for the investigation subject.

Table 8: Investigation Subject Associated Observations

Code Description Code System OID Value Type Card.
3 age 2.16.840.1.113883.3.989.2.1.1.19 PQ 0..1
16 gestationPeriod 2.16.840.1.113883.3.989.2.1.1.19 PQ 0..1
4 ageGroup 2.16.840.1.113883.3.989.2.1.1.19 CE 1..1
7 bodyWeight 2.16.840.1.113883.3.989.2.1.1.19 PQ 0..1
17 height 2.16.840.1.113883.3.989.2.1.1.19 PQ 0..1
22 lastMenstrualPeriodDate 2.16.840.1.113883.3.989.2.1.1.19 TS 0..1
C17049 Race 2.16.840.1.113883.3.26.1.1 CE 1..*
C16564 Ethnic Group 2.16.840.1.113883.3.26.1.1 CE 1..1
C102468 Illness at Time of Vaccination 2.16.840.1.113883.3.26.1.1 CE 0..1
32 reportedCauseOfDeath 2.16.840.1.113883.3.989.2.1.1.19 CE 0..*
5 autopsy 2.16.840.1.113883.3.989.2.1.1.19 BL 0..1
8 causeOfDeath 2.16.840.1.113883.3.989.2.1.1.19 CE 0..*
C103173 Age at Time of Vaccination 2.16.840.1.113883.3.26.1.1 PQ 0..1
C114855 Patient Military Status ICSR Terminology 2.16.840.1.113883.3.26.1.1 CE 0..1

Information on Race and Ethnic Group is only collected for US based reporting.

Information on gestation period is only collected if the subject is an unborn fetus.

Information on illness at time of vaccination is only collected for US based vaccine reporting. Cause of death and autopsy information is only collected if the subject has died.

12.1.1.5 Observation class code and mood code are as above.

12.1.1.6 WARNING: There is an observation code whose value is drawn from Table 8: Investigation Subject Associated Observations.

12.1.1.7 Code system for observation code is 2.16.840.1.113883.3.989.2.1.1.19.

12.1.1.8 Code system for observation code is 2.16.840.1.113883.3.26.1.1.

12.1.1.9 WARNING: Display name for the investigation subject associated information matches the code.

12.1.1.10 Value type for observation is drawn from Table 8: Investigation Subject Associated Observations.

12.1.1.11 If there is an observation collecting race or ethnic group, then code system for observation value is 2.16.840.1.113883.3.26.1.1 (NCI Thesaurus).

12.1.1.12 If there is an observation collecting Illness at time of Vaccination (C102468), then MedDRA (2.16.840.1.113883.6.163) is the code system for observation value.

12.1.1.13 If there is an observation collecting reported cause of death or (autopsy determined) cause of death, then code system for observation value is 2.16.840.1.113883.6.163 (MedDRA).

12.1.1.14 If there is an observation value including MedDRA encoding, then code system version is recorded.

12.1.1.15 If there is an observation collecting reported cause of death or (autopsy determined) cause of death, then original text is recorded.

12.1.1.16 If the observation recording age (code = "3", "C103173") is present and not null, then unit must be valued and the UCUM codes for year, month, week, day, hour, and decade are used.

12.1.1.17 If the observation recording age (code = "3", "C103173") is present and not null, then the value may not exceed 120 years.

12.1.1.18 If the observation records body weight (code = "7"), then the UCUM code for kilograms is used.

12.1.1.19 A patient should have either birth time, age at time of reaction (observation code = 3), age at time of vaccination (observation code = C103173), or age group (observation code = 4), or gestation period (observation code = 16).

12.1.1.20 If the observation records height (code = "17"), then the UCUM code for centimeters is provided as the unit of measure.

12.1.1.21 If the observation records gestation period (code = "16"), then the UCUM codes for month, week, day, and trimester"{trimester}" are allowed.

12.1.1.22 If information is present and not null, for the observation recording age group, then value is either Foetus (0), Neonate (Preterm and Term newborns) (1), Infant (2), Child (3), Adolescent (4), Adult (5), or Elderly (6).

12.1.1.23 If age group information is unavailable, then null flavors ASKU, MSK, NI, UNK are allowed.

12.1.1.24 WARNING: Display name for age group information matches the code.

12.1.1.25 If information is present and not null, then code system for observation value is 2.16.840.1.113883.3.989.2.1.1.9.

12.1.1.26 If there is an observation recording last menstrual period date, then null flavor MSK is allowed.

12.1.1.27 If race information is present and not null, then observation value is either African American (C16352),American Indian or Alaska Native (C41259), Asian (C41260), Native Hawaiian or Other Pacific Islander (C41219), or White (C41261).

12.1.1.28 WARNING: If race information is present and not null, display name for race information matches the code.

12.1.1.29 If observation records Ethnic Group then value is either Hispanic or Latino (C17459), or Not Hispanic or Latino (C41222). If unavailable, null flavors UNK, MSK,NI indicate missing or unavailable information.

12.1.1.30 WARNING: Display name for ethnicity information matches the code.

12.1.1.31 If there is an observation code recording patient military status, then observation value is either Active Duty (C114854), or Reserve (C114857), or National Guard (C114858) and nullFlavor OTH is used in case of another military relationship.

12.1.1.32 WARNING: Display name for patient military status information matches the code.

12.1.1.33 If observation code is autopsy (5), then there may be one or more observations that records the autopsy determined cause of death.

12.1.1.34 Observation class code and mood code are as above.

12.1.1.35 Observation code is 8.

12.1.1.36 Code system is 2.16.840.1.113883.3.989.2.1.1.19.

12.1.1.37 WARNING: Display name "cause of death" matches the code.

12.1.1.38 Code system is 2.16.840.1.113883.6.163.

12.1.1.39 Code system version is recorded.

12.1.1.40 The value type is CE.

12.2 Relevant Medical History Details

The section includes structured and unstructured information from the subject's medical history. Only information pertinent to understanding the case is to be included.

12.2.1 Structured and Unstructured Information

<subjectOf2 typeCode="SBJ">
  <organizer classCode="CATEGORY" moodCode="EVN">
    <code code="1" codeSystem="2.16.840.1.113883.3.989.2.1.1.20" displayName="relevantMedicalHistoryAndConcurrentConditions"/>
    <component typeCode="COMP">
      <observation classCode="OBS" moodCode="EVN">
        <code code="844555" codeSystem="2.16.840.1.113883.6.163" codeSystemVersion="12.0"/>
        <effectiveTime xsi:type="IVL_TS">
          <low value="20090101"/>                      
          <high value="20090101"/>                        
        </effectiveTime>
        <outboundRelationship2 typeCode="COMP">
          <observation classCode="OBS" moodCode="EVN">
            <code code="10" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" displayName="comment"/>
            <value xsi:type="ED">Comment</value>                          
          </observation>
        </outboundRelationship2>
        <outboundRelationship2 typeCode="EXPL">
          <observation classCode="OBS" moodCode="EVN">
            <code code="38" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" displayName="familyHistory"/>
            <value xsi:type="BL" value="true"/>                        
          </observation>
        </outboundRelationship2>
        <inboundRelationship typeCode="REFR">
          <observation classCode="OBS" moodCode="EVN">
            <code code="13" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" displayName="continuing"/>
            <value xsi:type="BL" value="true"/>                        
          </observation>
        </inboundRelationship>
      </observation>
    </component>
    <component typeCode="COMP">
      <observation classCode="OBS" moodCode="EVN">
        <code code="18" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" displayName="historyAndConcurrentConditionText"/>
        <value xsi:type="ED">D.7.2</value>                    
      </observation>
    </component>
    <component typeCode="COMP">
      <observation classCode="OBS" moodCode="EVN">
        <code code="11" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" displayName="concomitantTherapy"/>
        <value xsi:type="BL" value="true"/>                    
      </observation>
    </component>
  </organizer>
</subjectOf2>

Validation Procedures

12.2.1.1 There is an organizer that contains medical history or concurrent condition information.

12.2.1.2 There may be one or more component observations that record a relevant medical history or concurrent condition item for the investigation subject.

12.2.1.3 Class code and mood code are as above.

12.2.1.4 There is an observation code.

12.2.1.5 Code system is 2.16.840.1.113883.6.163.

12.2.1.6 There is a code system version.

12.2.1.7 There may be an effective time.

The level of precision provided will vary depending on the data to be conveyed.

12.2.1.8 If effective time is provided, then it include up to two of the elements "low", "high", "width". If unavailable, the null flavors MSK, ASKU, NASK indicate missing information.

12.2.1.9 If effective time duration is provided then the UCUM codes for year, month, week, day, hour, minute and second are allowed.

12.2.1.10 If effective time is provided, then data type is IVL_TS.

12.2.1.11 Class code and mood code are as above.

12.2.1.12 There may be one to three observations code whose value is drawn from Table 9: Relevant Medical History Item Associated Observations.

Table 9: Relevant Medical History Item Associated Observations

Code Description Code System OID Value Type Card.
10 comment 2.16.840.1.113883.3.989.2.1.1.19 ED 0..1
38 familyHistory 2.16.840.1.113883.3.989.2.1.1.19 BL 0..1
13 continuing 2.16.840.1.113883.3.989.2.1.1.19 BL 0..1

12.2.1.13 Code system is 2.16.840.1.113883.3.989.2.1.1.19.

12.2.1.14 WARNING: Display name for the relevant medical history item associated observation matches the code.

12.2.1.15 If there is a family history of the condition, then the value "true" is provided. Otherwise, the observation is not present.

12.2.1.16 Value type for observation is drawn from Table 9: Relevant Medical History Item Associated Observations .

12.2.1.17 If there is no information available for an included continuing observation (code = 13), then null flavors MSK, ASKU, or NASK indicate missing information.

12.2.1.18 The comment is collected as text.

12.2.1.19 If other medical history information is included as one or more observations, then there may be an observation containing historyAndConcommitantConditionText.

12.2.1.20 If no other medical history information is included, then there is an observation containing historyAndConcommitantConditionText.

12.2.1.21 Class code and mood code are as above.

12.2.1.22 There may be one to two observations whose value is drawn from Table 10: Relevant Medical History General Observations.

Table 10: Relevant Medical History General Observations

Code Description Code System OID Value Type Card.
18 HistoryAndConcurrentConditionText 2.16.840.1.113883.3.989.2.1.1.19 ED 0..1
11 concomitantTherapy 2.16.840.1.113883.3.989.2.1.1.19 BL 0..1

There may be concomitant therapies such as radiotherapy, drug class, dietary supplements or other products not describable within the context of the contained organizer. In such cases, the relevant information is expected to be contained within the case narrative.

12.2.1.23 Code system is 2.16.840.1.113883.3.989.2.1.1.19.

12.2.1.24 WARNING: Display name for the relevant medical history general observation matches the code.

12.2.1.25 Value type for observation is drawn from Table 10: Relevant Medical History General Observations.

12.2.1.26 If there is no content for the History and Concurrent Condition Text, then null flavor UNK indicate missing information.

12.2.1.27 If there is concomitant therapy, then the value "true" is provided. Otherwise, the observation is not present.

12.3 Relevant Drug Details

This section includes substance administration information that is relevant as part of the investigation subject's past or current clinical history. This information is collected when a prior substance administration is associated with an adverse event.

12.3.1 Substance Administration Information

<subjectOf2 typeCode="SBJ">
    <organizer classCode="CATEGORY" moodCode="EVN">
        <code code="2" codeSystem="2.16.840.1.113883.3.989.2.1.1.20" displayName="drugHistory"/>
        <component typeCode="COMP">
        <substanceAdministration classCode="SBADM" moodCode="EVN">
            <effectiveTime xsi:type="IVL_TS">
                <low value="20090101"/>
                <high value="20090101"/>
            </effectiveTime>
            <consumable typeCode="CSM">
                <instanceOfKind classCode="INST">
                    <kindOfProduct classCode="MMAT" determinerCode="KIND">
                        <code code="765444" codeSystem="2.16.840.1.113883.6.69"/>
                        <name>Product Name</name>
                    </kindOfProduct>
                </instanceOfKind>
            </consumable>
            <outboundRelationship2 typeCode="RSON">
                <observation classCode="OBS" moodCode="EVN">
                    <code code="19" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" displayName="indication"/>
                    <value xsi:type="CE" code="34567855" codeSystem="2.16.840.1.113883.6.163" codeSystemVersion="12.1"/>
                </observation>
            </outboundRelationship2>
            <outboundRelationship2 typeCode="CAUS">
                <observation classCode="OBS" moodCode="EVN">
                    <code code="29" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" displayName="reaction"/>
                    <value xsi:type="CE" code="12345678" codeSystem="2.16.840.1.113883.6.163" codeSystemVersion="12.1"/>
                </observation>
            </outboundRelationship2>
            <outboundRelationship2 typeCode="FLFS">
                <sequenceNumber value="3"/>
                <substanceAdministration moodCode="INT" classCode="SBADM"/>
            </outboundRelationship2>
            <outboundRelationship2 typeCode="SUBJ">
                <observation classCode="OBS" moodCode="EVN">
                    <code code="C103173" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="Age at Time of Vaccination"/>
                    <value xsi:type="PQ" value="32" unit="a"/>
                    <!--  Age at Time of vaccination -->
                </observation>
            </outboundRelationship2>
        </substanceAdministration>
    </organizer>
</subjectOf2>

Validation Procedures

12.3.1.1 There may be an an organizer that contains drug history information.

12.3.1.2 If the drug history organizer is present, then there is at least one substance administration. There may be several.

12.3.1.3 Class code and mood code are as above.

12.3.1.4 There can be effective time information. The information includes start date, stop date, duration. Start and stop dates have a minimum precision of year. If unavailable the null flavors MSK, ASKU, NASK indicate missing or unavailable information.

The effective time is expected to be an interval to allow conveying information regarding the start and stop dates for the substance administration. If dates are unknown, the duration of administration may be provided. The level of precision provided will vary depending on the data to be conveyed.

12.3.1.5 There is consumable information to indicate the medicinal product that was consumed.

12.3.1.6 Type code is as above.

12.3.1.7 Name is provided for the consumable product. if unavailable, then null flavor "NA" is provided within the name.

12.3.1.8 WARNING: There is a product code.

12.3.1.9 If there is a product code and it is a US source report, then the code (NDC/NHRIC product code) has at least two segments separated by a hyphen. It may have a third segment which is also separated by a hyphen.

12.3.1.10 TIME SENSITIVE WARNING: If there is a product code, then code system and code system version is valued.

12.3.1.11 TIME SENSITIVE WARNING: If there is a product code and it is a US source report, then code system version is a time stamp in the form CCYYMMDDHHMMSS. It indicates the date/time a reference file was downloaded from FDA. Date/time must be provided with at least the precision of year.

12.3.1.12 TIME SENSITIVE WARNING: If there is a product code and it is a US source report, then Code system is 2.16.840.1.113883.6.69.

12.3.1.13 Role class code, entity class code, and entity determiner code are as above.

12.3.1.14 There may be one to three observations code whose value is drawn from Table 11: Relevant Drug History Observations.

Table 11: Relevant Drug History Observations

Code Description Code System OID Value Type Card.
19 indication 2.16.840.1.113883.3.989.2.1.1.19 CE 0..*
29 reaction 2.16.840.1.113883.3.989.2.1.1.19 CE 0..*

12.3.1.15 Code system is drawn from Table 11: Relevant Drug History Observations.

12.3.1.16 WARNING: Display name for the relevant drug history observation matches the code.

12.3.1.17 Value type for observation is drawn from Table 11: Relevant Drug History Observations.

12.3.1.18 If observation code = "29" (reaction), then code system for observation value then code system is 2.16.840.1.113883.6.163 (MedDRA).

12.4 Relevant Vaccine History Details

This section includes a record of vaccinations received by the subject within the four week period prior to the suspect vaccination. The section is used for US based vaccine event reporting.

12.4.1 Records of Vaccine

<MCCI_IN200100UV01>
...
    <PORR_IN049016UV>
  ...              
   <component>
    <adverseEventAssessment>
        <subject1>
            <primaryRole>
                <subjectOf2 typeCode="SBJ">
                    <organizer classCode="CATEGORY" moodCode="EVN">
                        <code code="C102467" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="other vaccinations given within four weeks"/>
                        <component typeCode="COMP">
                            <substanceAdministration moodCode="EVN" classCode="SBADM">
                                <effectiveTime value="20090101"/>
                                <approachSiteCode code="C105633" displayName="Left Arm" codeSystem="2.16.840.1.113883.3.26.1.1"/>
                                <routeCode code="C28161" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="Intramuscular route of administration"/>
                                <consumable typeCode="CSM">
                                    <instanceOfKind classCode="INST">
                                        <productInstanceInstance classCode="MMAT" determinerCode="INSTANCE">
                                        <lotNumberText>123444-AB</lotNumberText>
                                        </productInstanceInstance>
                                        <kindOfProduct classCode="MMAT" determinerCode="KIND">
                                            <code code="6669" codeSystem="2.16.840.1.113883.6.69" codeSystemVersion="07-Oct-2013"/>
                                            <name>Measles vaccine</name>
                                            <asManufacturedProduct classCode="MANU">
                                                <subjectOf typeCode="SBJ">
                                                    <approval classCode="CNTRCT" moodCode="EVN">
                                                        <holder typeCode="HLD">
                                                            <role classCode="HLD">
                                                                <playingOrganization classCode="ORG" determinerCode="INSTANCE">
                                                                    <name>Big Biopharma Vaccines</name>
                                                                    <!-- Name of Holder / Applicant -->
                                                                </playingOrganization>
                                                            </role>
                                                        </holder>
                                                </subjectOf>
                                            </asManufacturedProduct>
                                        </kindOfProduct>
                                    </instanceOfKind>
                                </consumable>
                                <outboundRelationship2 typeCode="FLFS">
                                    <sequenceNumber value="2"/>
                                    <substanceAdministration classCode="SBADM" moodCode="INT">
                                    </substanceAdministration>
                                </outboundRelationship2>
                            </substanceAdministration>
                        </component>
                    </organizer>
                </subjectOf2>
            </primaryRole>
        </subject1>
    </adverseEventAssessment>
  </component>
  </PORR_IN049016UV>
 ...
</MCCI_IN200100UV01>

Validation Procedures

12.4.1.1 WARNING: Display name is "Other Vaccinations Given within Four Weeks".

12.4.1.2 There is one to many component substance administrations.

12.4.1.3 If there are no other vaccinations to report, then there is a single component substance administration in which the product name is valued with nullFlavor = "NI".

12.4.1.4 Class code and mood code are as above.

12.4.1.5 If there are vaccinations to report, then there may be an effective time low value recording the relevant date for the substance administration. Otherwise the effective time element can be omitted.

12.4.1.6 Effective time is not later than the effective time provided for the suspect substance administration.

12.4.1.7 There may be an approach site code that records the body site used for the vaccination. If unavailable, the null flavors UNK ASKU or NI indicate lack of information.

12.4.1.8 If there are vaccinations to report, then there may be a route code.

12.4.1.9 There is consumable information.

12.4.1.10 Type code is as above.

12.4.1.11 There may be instance information.

12.4.1.12 Lot number is collected as text.

12.4.1.13 If lot information is provided, then class code and determiner code are as above. Otherwise the productInstanceInstance element is not included.

12.4.1.14 Class code and determiner code are as above.

12.4.1.15 Product name is collected. Also, if there no vaccinations to report, then the nullFlavor "NI" is provided as an attribute of name.

12.4.1.16 There may be a product code.

12.4.1.17 If there is a product code, then code system and code system version is valued.

12.4.1.18 If there is a product code and it is a US source report, then code system version is a time stamp. It indicates the date/time a reference file was downloaded from FDA. Date/time must be provided with at least the precision of year.

12.4.1.19 If there is a product code and it is a US source report, then the code (NDC/NHRIC product code) has at least two segments separated by a hyphen. It may have a third segment which is also separated by a hyphen.

The code system to be used is the National Drug Code (NDC) for all known US licensed products. The code value is drawn from the NDC code system.

12.4.1.20 If there is a product code and it is a US source report, then code system is 2.16.840.1.113883.6.69.

12.4.1.21 There may be manufactured product information.

Manufacturer information is collected as that of the marketing authorization holder.

12.4.1.22 Role class code, participation type code, and act class and determiner code are as above.

12.4.1.23 There is a name for the regional marketing authorization holder.

12.4.1.24 There may be information to record the dose in series for a substance administration.

12.4.1.25 There may be an observation that records the subject's age at the time of the reaction onset.

12.4.1.26 Code system to be used is 2.16.840.1.113883.3.26.1.1.

12.4.1.27 Observation value type is PQ.

12.4.1.28 Display name is "Age at Time of Adverse Event".

12.4.1.29 Unit of measure is drawn from the list of UCUM codes documented in Appendix A: Unit of Measure Value Set.

12.4.1.30 There may be a substance administration that conveys information regarding which dose in a series was associated with the prior adverse event.

12.4.1.31 If dose in series information is included, then there is an outbound relationship sequence number.

12.4.1.32 If dose in series information is included, then there is a substance administration.

12.4.1.33 If dose in series information is included, then class code and mood code are as above. Otherwise this content can be omitted.

12.4.1.34 If dose in series information is included, then substance administration text contains the value "series". Otherwise this content may be omitted.

12.5 Relevant Tests & Procedures

This section captures the tests and procedures performed to diagnose or confirm the reaction/event, including those tests done to investigate (exclude) a non-drug cause (e.g. serologic tests for infectious hepatitis in suspected drug-induced hepatitis). Both positive and negative results should be reported. While structured information is preferable, provisions are made to transmit the information as free text.

12.5.1 Tests and Procedures Information

<subjectOf2 typeCode="SBJ">
  <organizer classCode="CATEGORY" moodCode="EVN">
    <code code="3" codeSystem="2.16.840.1.113883.3.989.2.1.1.20" displayName="testsAndProceduresRelevantToTheInvestigation"/>
    <component typeCode="COMP">
      <observation classCode="OBS" moodCode="EVN">
        <code code="458832" codeSystem="2.16.840.1.113883.6.163" codeSystemVersion="12.0">            
          <originalText>A name for the test</originalText>              
        </code>
        <effectiveTime value="20090101"/>            
        <value xsi:type="IVL_PQ">
          <center value="10" unit="mg/dl"/>              
        </value>
        <interpretationCode code="2" codeSystem="2.16.840.1.113883.3.989.2.1.1.12"/>        
        <referenceRange typeCode="REFV">
          <observationRange classCode="OBS" moodCode="EVN.CRT">
            <value xsi:type="PQ" value="40" unit="mg/dl"/>            
            <interpretationCode code="L" codeSystem="2.16.840.1.113883.5.83"/>
          </observationRange>
        </referenceRange>
        <referenceRange typeCode="REFV">
          <observationRange classCode="OBS" moodCode="EVN.CRT">
            <value xsi:type="PQ" value="110" unit="mg/dl"/>              
            <interpretationCode code="H" codeSystem="2.16.840.1.113883.5.83"/>
          </observationRange>
        </referenceRange>
        <outboundRelationship2 typeCode="PERT">
          <observation classCode="OBS" moodCode="EVN">
            <code code="10" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" displayName="comment"/>
            <value xsi:type="ED">F.r.6</value>              
          </observation>
        </outboundRelationship2>
        <outboundRelationship2 typeCode="REFR">
          <observation classCode="OBS" moodCode="EVN">
            <code code="25" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" displayName="moreInformationAvailable"/>
            <value xsi:type="BL" value="true"/>                
          </observation>
        </outboundRelationship2>
      </observation>
    </component>
  </organizer>
</subjectOf2>

Validation Procedures

12.5.1.1 There may be one to many observations that record relevant test results for the investigation subject.

12.5.1.2 Class code and mood code are as above.

12.5.1.3 There is an observation code. Either code or original text is recorded.

12.5.1.4 If there is a code, then code system is 2.16.840.1.113883.6.163 (MedDRA).

12.5.1.5 If there is code system, then code system version is collected.

12.5.1.6 If observation code is unavailable then original text element is collected.

12.5.1.7 There is an effective time with at least the precision of year in the format CCYYMMDD. If unavailable, the null flavor UNK indicates missing information.

Effective time is the data type TS to allow conveying information regarding the test date.

12.5.1.8 There may an observation value containing result information having valid xsi:types including CD, PQ, IVL_PQ and ED and if PQ or IVL_PQ used, then the null flavors PINF or NINF may appear to indicate non-numeric limits to intervals.

The value data type may be IVL_PQ. If the exact result is given, it is included within the center property of the type. If upper and lower bounds are provided, the high and low properties are to be used. If only a single bound is provided, either the high or low property is to be used. The inclusive properties are used to indicate whether the boundary of the interval is included within the result that is used to record the type of observation that is being valued. A MedDRA LLT term should be used. The value data type may be ED. This format is used when result value and unit cannot be split. In such a case, mediaType ="text/plain". The result value is entered as text.

12.5.1.9 There may be an interpretation code that provides conclusions for the test result.

12.5.1.10 Either observation value or interpretation code must be valued for an observation recording relevant test results.

12.5.1.11 Code system is 2.16.840.1.113883.3.989.2.1.1.12.

12.5.1.12 The interpretation code is 1 (Positive), 2 (Negative), 3 (Borderline), or 4 (Inconclusive).

12.5.1.13 There may be one or more records of the normal value for the result. This information is provided as an observation range.

12.5.1.14 Class code and mood code are as above.

12.5.1.15 Data type is PQ for Observation range.

12.5.1.16 Unit of measure is drawn from the list of UCUM codes documented in Appendix A: Unit of Measure Value Set.

12.5.1.17 Code system is 2.16.840.1.113883.5.83.

12.5.1.18 Observation interpretation code is either L (low) or H (high).

12.5.1.19 There may be a one or two observations related to the test result.

The observations may record either a comment relevant to the result observation item, or an indication that there is more information available with regard to the test result.

12.5.1.20 Type code and observation class code and mood code are as above.

12.5.1.21 There is an observation code.

12.5.1.22 The observation code value is either Comments on the result (10) or More information available (25).

12.5.1.23 Code system is 2.16.840.1.113883.3.989.2.1.1.19.

12.5.1.24 WARNING: Display name for the observation related to the test result matches the code.

12.5.1.25 There is an observation value.

12.5.1.26 If the observation record contains comments, then data type is ED.

12.5.1.27 The comment is collected as text.

12.5.1.28 If the observation is an indication there is more information available then the data type is "BL".

13 Related Subject Clinical History

This section addresses additional information collected for a party who has a defined relationship to the investigation subject. Information may be collected for a subject's mother, when the subject is a fetus or nursing infant.

13.1 Related Subject Details

This section addresses additional information collected for the related person.

There is an organizer that includes information from the subject's medical history. The content of this element is discussed in Section 12.2 Relevant Medical History Details.

There may be an organizer that includes information regarding the subject's drug history. The content of this element is discussed in Section 12.3 Relevant Drug Details.

13.1.1 Additional Information of Related Person

<MCCI_IN200100UV01>
...
    <PORR_IN049016UV>
    ...
    <component>
        <adverseEventAssessment>
            <subject1>
                <primaryRole>
                    <player1>
                        <role>
                            <subjectOf2 typeCode="SBJ">
                                <observation classCode="OBS" moodCode="EVN">
                                    <code code="C17049" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="Race"/>
                                    <value xsi:type="CE" code="41260" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="Asian"/>
                                </observation>
                            </subjectOf2>
                            <subjectOf2 typeCode="SBJ">
                                <observation classCode="OBS" moodCode="EVN">
                                    <code code="C17049" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="Race"/>
                                    <value xsi:type="CE" code="41259" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="American Indian or Alaska Native"/>
                                </observation>
                            </subjectOf2>
                            <subjectOf2 typeCode="SBJ">
                                <observation classCode="OBS" moodCode="EVN">
                                    <code code="C16564" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="Ethnic Group"/>
                                    <value xsi:type="CE" code="41260" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="Asian"/>
                                </observation>
                            </subjectOf2>
                            <subjectOf2 typeCode="SBJ">
                                <observation classCode="OBS" moodCode="EVN">
                                <code code="3" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" displayName="age"/>
                                <value xsi:type="PQ" value="33" unit="a"/>
                                </observation>
                            </subjectOf2>
                            <subjectOf2 typeCode="SBJ">
                                <observation classCode="OBS" moodCode="EVN">
                                    <code code="C103173" codeSystem="2.16.840.1.113883.3.26.1.1" displayName="age time of vaccination"/>
                                    <value xsi:type="PQ" value="32" unit="a"/>
                                </observation>
                            </subjectOf2>
                            <subjectOf2 typeCode="SBJ">
                                <observation classCode="OBS" moodCode="EVN">
                                    <code code="22" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" displayName="lastMenstrualPeriodDate"/>
                                    <value xsi:type="TS" value="20090101"/>
                                </observation>
                            </subjectOf2>
                            <subjectOf2 typeCode="SBJ">
                                <observation classCode="OBS" moodCode="EVN">
                                    <code code="7" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" displayName="bodyWeight"/>
                                    <value xsi:type="PQ" value="50" unit="kg"/>
                                </observation>
                            </subjectOf2>
                            <subjectOf2 typeCode="SBJ">
                                <observation classCode="OBS" moodCode="EVN">
                                    <code code="17" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" displayName="height"/>
                                    <value xsi:type="PQ" value="160" unit="cm"/>
                                </observation>
                            </subjectOf2>
                            <subjectOf2 typeCode="SBJ">
                            <organizer .../>
                            </subjectOf2>
                            <subjectOf2 typeCode="SBJ">
                            <organizer>
                            </organizer>
                            </subjectOf2>
                        </role>
                    </player1>
                </primaryRole>
            </subject1>
        </adverseEventAssessment>
    </component>
  </PORR_IN049016UV>
 ...
</MCCI_IN200100UV01>

Validation Procedures

13.1.1.1 If observation records Ethnic Group then value is either Hispanic or Latino (C17459), or Not Hispanic or Latino (C41222). If unavailable, null flavors UNK, MSK, or NI indicate missing or unavailable information.

13.1.1.2 If there is an observation recording last menstrual period date for the related subject, then null flavors MSK, ASKU, NASK are allowed.

13.1.1.3 If the observation recording age (code = "3") is present and not null, then unit must be valued and the UCUM codes for year and decade are used.

13.1.1.4 There may be one to many observations that record information that is relevant for the parent of the investigation subject. Observation code values are drawn from Table 8: Investigation Subject Associated Observations.

13.1.1.5 The following items from the Investigation Subject Associated Observations Table are not relevant for a related person: Patient Military Status, Number of Siblings, reportedCauseofDeath, autopsy, causeOfDeath.

13.1.1.6 Relevant medical history details information may be collected for the parent of the investigation subject.

13.1.1.7 Relevant drug details information may be collected for the parent of the investigation subject.

13.1.1.8 Relevant vaccine history details information may be collected for the related person (both for the parent and for the sibling) associated with the investigation subject.

This information is also collected for the investigation subject. The rules defined there apply as well.

Ethnicity and race is only collected for US based adverse event reporting. For VAERS reporting, this attribute is required and allowable null flavor values are: no information (NI), asked but unknown (ASKU) or masked (MSK) due to privacy restrictions.

13.2 Relevant Medical History Details

The section includes structured and unstructured information from the related subject's medical history. Only information pertinent to understanding the case is to be included.

13.2.1 Structural, Unstructured Information of Related Subject

<subjectOf2 typeCode="SBJ">
  <organizer classCode="CATEGORY" moodCode="EVN">
    <code code="1" codeSystem="2.16.840.1.113883.3.989.2.1.1.20" displayName="relevantMedicalHistoryAndConcurrentConditions"/>
    <component typeCode="COMP">
      <observation classCode="OBS" moodCode="EVN">
        <code code="xxy3-55" codeSystem="2.16.840.1.113883.6.163" codeSystemVersion="3.2"/>      
        <effectiveTime xsi:type="IVL_TS">
          <low value="20090101"/>          
          <high value="20090101"/>          
        </effectiveTime>
        <outboundRelationship2 typeCode="COMP">
          <observation classCode="OBS" moodCode="EVN">
            <code code="10" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" displayName="comment"/>
            <value xsi:type="ED">This is what we thought</value>            
          </observation>
        </outboundRelationship2>
        <inboundRelationship typeCode="REFR">
          <observation classCode="OBS" moodCode="EVN">
            <code code="13" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" displayName="continuing"/>
            <value xsi:type="BL" value="true"/>        
          </observation>
        </inboundRelationship>
      </observation>  
    </component>  
    <component typeCode="COMP">
      <observation classCode="OBS" moodCode="EVN">
        <code code="18" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" displayName="historyAndConcurrentConditionText"/>
        <value xsi:type="ED">Text for Relevant Medical History and Concurrent Conditions (not including reaction / event</value>
      </observation>
    </component>
  </organizer>
</subjectOf2>

Validation Procedures

13.2.1.1 There may be one or more observations that record relevant medical history or concurrent condition items for the related person.

The same information is collected for investigation subject in section 12.2. Hence the whole template which defines the rules in that section is reused.

13.3 Relevant Drug Details

This section includes substance administration information that is relevant as part of the related subject's past or current clinical history.

For US based vaccine reporting, there is additional information collected.

13.3.1 Substance Administration Information

<role classCode="PRS">
    <subjectOf2 typeCode="SBJ">
        <organizer classCode="CATEGORY" moodCode="EVN">
            <code code="2" codeSystem="2.16.840.1.113883.3.989.2.1.1.20" displayName="drugHistory"/>
            <component typeCode="COMP">
                <substanceAdministration classCode="SBADM" moodCode="EVN">
                    <effectiveTime xsi:type="IVL_TS">
                        <low value="20090101"/>
                        <high value="20090101"/>
                    </effectiveTime>
                    <consumable typeCode="CSM">
                        <instanceOfKind classCode="INST">
                            <kindOfProduct classCode="MMAT" determinerCode="KIND">
                                <code code="765444" codeSystem="2.16.840.1.113883.6.69"/>
                                <name>Product Name</name>
                            </kindOfProduct>
                        </instanceOfKind>
                    </consumable>
                    <outboundRelationship2 typeCode="RSON">
                        <observation classCode="OBS" moodCode="EVN">
                            <code code="19" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" displayName="indication"/>
                            <value xsi:type="CE" code="34567855" codeSystem="2.16.840.1.113883.6.163" codeSystemVersion="12.1"/>
                        </observation>
                    </outboundRelationship2>
                    <outboundRelationship2 typeCode="CAUS">
                        <observation classCode="OBS" moodCode="EVN">
                            <code code="29" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" displayName="reaction"/>
                            <value xsi:type="CE" code="12345678" codeSystem="2.16.840.1.113883.6.163" codeSystemVersion="12.1"/>
                        </observation>
                    </outboundRelationship2>
                </substanceAdministration>
            </component>
        </organizer>
    </subjectOf2>
</role>

Validation Procedures

13.3.1.1 There may be one or more observations that record relevant drug history or concurrent condition items for the related person.

The same information is collected for investigation subject in section 12.3. Hence the whole template which defines the rules in that section is reused.

13.3.1.2 Name may be provided for the consumable product.

14 Research Study Relationship

There are cases in which the subject of an investigation is enrolled in a clinical trial/research study. If so, it is expected that information will be collected to identify the study.

14.1 Research Study Information

14.1.1 Code, Id and Title

<MCCI_IN200100UV01>
...
  <PORR_IN049016UV>
     ...
        <investigationEvent classCode="INVSTG" moodCode="EVN">
            <component typeCode="COMP">
            <adverseEventAssessment classCode="INVSTG" moodCode="EVN">
              <subject1 typeCode="SBJ">
                <primaryRole>
                  <subjectOf1 typeCode="SBJ">
                    <researchStudy classCode="CLNTRL" moodCode="EVN">
                      <id extension="4555-3" root="2.16.840.1.113883.3.989.2.1.3.5"/>
                      <code code="2" codeSystem="2.16.840.1.113883.3.989.2.1.1.8"/>
                      <title>Profound Study</title>
                    </researchStudy>
                  </subjectOf1>
                </primaryRole>

Validation Procedures

14.1.1.1 There may be one or more research study elements.

14.1.1.2 If ICH Report Type (observation code = "1"), takes on the value "Report from Study" (2), then research study information, including the type of study, is included.

14.1.1.3 Class code and mood code are as above.

14.1.1.4 There may be an id for the study, which is carried within id extension.

14.1.1.5 WARNING: Id root is 2.16.840.1.113883.3.989.2.1.3.5.

14.1.1.6 There is a code of study type.

14.1.1.7 Code system is 2.16.840.1.113883.3.989.2.1.1.8.

14.1.1.8 Code value is either Clinical trials (1), Individual patient use (2), or Other studies (3).

14.1.1.9 WARNING: Display name for the study type matches the code.

14.1.1.10 There may be a title containing the name of the study.

14.1.2 Author Information

<MCCI_IN200100UV01>
  ...
    <PORR_IN049016UV>
       ...
      <investigationEvent classCode="INVSTG" moodCode="EVN">
        <component typeCode="COMP">          
          <primaryRole>
            <subjectOf1 typeCode="SBJ">
              <researchStudy classCode="CLNTRL" moodCode="EVN">
                <authorization typeCode="AUTH">
                  <studyRegistration classCode="ACT" moodCode="EVN">
                    <id extension="23489-34" root="2.16.840.1.113883.3.989.2.1.3.6"/>
                    <author typeCode="AUT">
                      <territorialAuthority classCode="TERR">
                      <governingPlace classCode="COUNTRY" determinerCode="INSTANCE">
                        <code code="US" codeSystem="1.0.3166.1.2.2"/>
                      </governingPlace>
                    </territorialAuthority>
                    </author>
                  </studyRegistration>
                </authorization>
              </researchStudy>
            </subjectOf1>
          </primaryRole>

Validation Procedures

14.1.2.1 There is an id extension that records the study registration identifier for the study. If unavailable, the null flavor ASKU or NASK indicate lack of information.

14.1.2.2 Root id is 2.16.840.1.113883.3.989.2.1.3.6.

14.1.2.3 There is a territorial authority governing place.

14.1.2.4 Role class code and entity class code and determiner code are as above.

14.1.2.5 There is a code for country of registration. if unavailable, the null flavor ASKU or NASK indicate lack of information.

14.1.2.6 Code system is 1.0.3166.1.2.2.

14.1.2.7 If a non-null value is provided, then country code comes from the ISO alpha 2 country code list, with the addition that the value "EU" may be used.

15 Causality Assessment

15.1 Event Causality

Evaluation of event causality is a key component of the adverse event assessment. The assessment is used to indicate the suspect product use or administration for the report, and may also identify additional product uses as concomitant or interacting. The section is also used to provide information on the degree of suspected relatedness between individual reactions and the different drugs that were identified within the report.

Two kinds of observation will be found within this section:

The observations convey information regarding whether use of a product is considered to be suspect, interacting or concomitant within the context of the adverse event assessment.

The observations to convey information regarding the degree of relatedness between a reported reaction and a suspect subject administration within the context of the adverse event assessment.

15.1.1 Event Causality Information

<adverseEventAssessment>
  <component typeCode="COMP">
    <causalityAssessment classCode="OBS" moodCode="EVN"> 
      <code code="20" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" displayName="interventionCharacterization"/>
      <value xsi:type="CE" code="G.k.1" codeSystem="2.16.840.1.113883.3.989.2.1.1.13"/>
      <subject2 typeCode="SUBJ">
        <productUseReference classCode="SBADM" moodCode="EVN">
          <id root="3c91b4d5-e039-4a7a-9c30-67671b0ef9e4"/>
        </productUseReference>
      </subject2>
    </causalityAssessment>
  </component>

  <component typeCode="comp">
    <causalityAssessment classCode="OBS" moodCode="EVN">
      <code code="39" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" displayName="causality"/>
      <value xsi:type="ST">Result of assessment</value>
      <methodCode>
        <originalText>method of assessment</originalText>
      </methodCode>
      <author typeCode="AUT"> 
        <assignedEntity classCode="ASSIGN">
          <code>
            <originalText>Assessment source</originalText>
          </code>
        </assignedEntity>
      </author>
      <subject2 typeCode="SUBJ">
        <productUseReference classCode="SBADM" moodCode="EVN">
          <id root="3c91b4d5-e039-4a7a-9c30-67671b0ef9e4"/>
        </productUseReference>
      </subject2>
      <subject1 typeCode="SUBJ">
        <adverseEffectReference classCode="ACT" moodCode="EVN">
          <id root="154eb889-958b-45f2-a02f-42d4d6f4657f"/>
        </adverseEffectReference>
      </subject1>

    </causalityAssessment>
  </component>
</adverseEventAssessment>

Validation Procedures

15.1.1.1 There are one or more causality assessment observations.

15.1.1.2 Class code and mood code are as above.

15.1.1.3 There is an observation code.

15.1.1.4 Code system is 2.16.840.1.113883.3.989.2.1.1.19.

15.1.1.5 Code value is either interventionCharacterization (20), or causality (39).

15.1.1.6 WARNING: Display name for the intervention characterization or causality information matches the code.

15.1.1.7 There is an observation value with data type CE for the intervention characterization observation (observation code = 20).

15.1.1.8 Code system for the intervention characterization observation (observation code = 20) is 2.16.840.1.113883.3.989.2.1.1.13.

15.1.1.9 If observation code is Intervention Characterization (20), then observation value is either Suspect (1), Concomitant (2), Interacting (3), or Drug Not Administered (4).

15.1.1.10 WARNING: Display name for the intervention characterization matches the code.

15.1.1.11 Class code and mood code are as above.

15.1.1.12 There is a product use reference id for the intervention characterization observation (observation code = 20).

Id records the identity of the substance administration associated with the causality assessment.

15.1.1.13 There is one and only one intervention characterization observation for each substance administration recorded as a product event within the drugInformation section.

The observations convey information regarding whether use of a product is considered to be suspect, interacting or concomitant within the context of the adverse event assessment.

15.1.1.14 WARNING: Product use reference id is a GUID.

Above id value matches that of one of the substance administrations included within this report.

15.1.1.15 The product use reference id value matches the substance administration id appearing within the ICSR instance.

15.1.1.16 There is an observation value conveying reaction relatedness information with data type ST for the causality observation (observation code = 39).

15.1.1.17 There may be a method code within the causality observation (observation code = 39).

Method code conveys the method used for ascertaining the reaction relatedness.

15.1.1.18 If method code is present, then original text is used to capture the method in method code.

15.1.1.19 There is an author or source for the relatedness assessment observation (observation code = 39).

15.1.1.20 If the author participation is included, then type code and class code are as above.

15.1.1.21 There is an assigned entity code value to record the author of the causality assessment.

15.1.1.22 If the author participation is included, then original text is used to capture the assessment source as a text entry.

15.1.1.23 There is an adverse effect reference id within the causality observation (observation code = 39).

This id record the identity of the reaction or event associated with the causality assessment.

15.1.1.24 Class code and mood code are as above.

15.1.1.25 WARNING: The adverse effect reference id is GUID.

15.1.1.26 The adverse effect reference id value matches the reaction observation id appearing within the ICSR instance.

15.1.1.27 There is a product use reference id within the causality observation (observation code = 39).

15.1.1.28 WARNING: The product use reference id is a GUID.

15.1.1.29 The product use reference id value matches the substance administration id appearing within the ICSR instance.

16 Adverse Event Source Reports

16.1 Primary Source Information

<MCCI_IN200100UV01>
...
  <PORR_IN049016UV>
...
  <controlActProcess>
  ...
    <subject>
      <investigationEvent>
        <outboundRelationship typeCode="SPRT">
          <priorityNumber value="1"/>
          <relatedInvestigation classCode="INVSTG" moodCode="EVN">
            <code code="2" codeSystem="2.16.840.1.113883.3.989.2.1.1.22" displayName="sourceReport"/>
            <subjectOf2 typeCode="SUBJ">
              <controlActEvent classCode="CACT" moodCode="EVN">
                <author typeCode="AUT">
                  <assignedEntity/>
                </author>
              </controlActEvent>
            </subjectOf2>
          </relatedInvestigation>
        </outboundRelationship>
            </investigationEvent>
    </subject>
     ...
  </controlActProcess>
  ...
  </PORR_IN049016UV>  
...
</MCCI_IN200100UV01>

Validation Procedures

16.1.1.1 There is one or more related investigation.

16.1.1.2 There is an investigation code.

Code designates the type of investigation and consequently the role played by the report.

16.1.1.3 There may be a priority number.

Priority Number Indicate the priority order of source reports. However priority number will only be valued - as "1", for the highest priority reporter.

16.1.1.4 Priority number is only valued for one instance of the source report.

16.1.1.5 The primary source for regulatory purposes is assigned priority number = "1".

16.1.1.6 Class code and mood code are as above.

16.1.1.7 Code system is 2.16.840.1.113883.3.989.2.1.1.22.

16.1.1.8 WARNING: Display name for the related report type matches the code.

16.1.1.9 There is a subject control act.

16.1.1.10 Class code and mood codes are as above.

16.1.1.11 If the report is a source report (code = 2), then there is an address for the source reporter.

16.1.1.12 If the report is a source report (code = 2), then there is an address containing street address line (which may repeat one time), city, state, county, postal code, and if unavailable, then the null flavors MSK, NASK, ASKU indicate lack of information.

16.1.1.13 If the US is the source country, then the null flavor MSK is not allowed for the primary reporter address or address parts.

16.1.1.14 If the US is the source country and if the patient is the primary reporter (Reporter/asQualifiedEntity/code = C16960 (patient), then address includes county as an address part.

16.1.1.15 There is a telephone number for the author of the source report. If unavailable, the null flavors MSK, ASKU, or NASK indicate lack of information.

16.1.1.16 Fax number may be provided as well.

16.1.1.17 There is an email address for the author of the source report. If unavailable, the null flavors MSK, ASKU, or NASK indicate lack of information.

16.1.1.18 If the US is the source country, then the null flavor MSK is not allowed for primary reporter telecommunications addresses.

16.1.2 Source Reporter Name, Location & Qualification

<relatedInvestigation classCode="INVSTG" moodCode="EVN">
  <code code="2" codeSystem="2.16.840.1.113883.3.989.2.1.1.22" displayName="sourceReport"/>
   <subjectOf2 typeCode="SUBJ">
     <controlActEvent classCode="CACT" moodCode="EVN">
       <author typeCode="AUT">
           <assignedEntity>
          <assignedPerson classCode="PSN" determinerCode="INSTANCE">
          <name>
            <prefix>Professor</prefix>                        
            <given>Ronald</given>                        
            <given>Robert</given>                          
            <family>Rhodes</family>                        
          </name>
          <asQualifiedEntity classCode="QUAL">
            <code code="2" codeSystem="2.16.840.1.113883.3.989.2.1.1.6"/>
          </asQualifiedEntity>
          <asLocatedEntity classCode="LOCE">
            <location classCode="COUNTRY" determinerCode="INSTANCE">
             <code code="US" codeSystem="1.0.3166.1.2.2"/>
            </location>
          </asLocatedEntity>
       </assignedPerson>                    
    </assignedEntity>
  </author>
</controlActEvent>

Validation Procedures

16.1.2.1 Name information including prefix, surname, and two given names is required for the source reporter.

16.1.2.2 If a name component is unavailable, then the null flavors MSK, ASKU, NASK are allowed.

16.1.2.3 If the US is the source country, then nullFlavor MSK is not allowed for the primary reporter (the reporter instance in which priorityNumber ="1").

16.1.2.4 There can be professional status or qualification information for the source reporter. If the source reporter was designated as the primary source for regulatory purposes (priority number = "1"), then there is professional status or qualification information for the source reporter.

16.1.2.5 The qualified entity code value is either Physician (1), Pharmacist (2), Other health professional (3), Lawyer (4), Consumer or other non health professional (5), Patient (C16960), or Parent (C42709).

16.1.2.6 If the value is not known, then nullFlavors UNK or OTH can be used.

16.1.2.7 If qualification code = 1, 2, 3, 4, or 5, then code system is 2.16.840.1.113883.3.989.2.1.1.6.

16.1.2.8 If qualification code = C16960 or C42709, then code system is 2.16.840.1.113883.3.26.1.1

16.1.2.9 There can be a country. If country information is not available, then null flavors MSK, ASKU, NASK can be used.

16.1.2.10 There is a location country code value. If unavailable, the null flavors MSK, ASKU, NASK can be used.

16.1.2.11 If a non-null value is provided, then code system is 1.0.3166.1.2.2.

16.1.2.12 If a non-null value is provided, then country code comes from the ISO alpha 2 country code list.

17 Adverse Event First Sender

17.1 First Sender of the Case

<MCCI_IN200100UV01>
...
  <PORR_IN049016UV>
...
  <controlActProcess>
  ...
    <subject>
      <investigationEvent>
        <outboundRelationship typeCode="SPRT">
          <relatedInvestigation classCode="INVSTG" moodCode="EVN">
            <code code="1" codeSystem="2.16.840.1.113883.3.989.2.1.1.22" displayName="initialReport"/>
            <subjectOf2 typeCode="SUBJ">
              <controlActEvent classCode="CACT" moodCode="EVN">
                <author typeCode="AUT">
                  <assignedEntity classCode="ASSIGNED">
                    <code code="1" displayName="regulator" codeSystem="2.16.840.1.113883.3.989.2.1.1.3"/>            
                  </assignedEntity>
                </author>
              </controlActEvent>
            </subjectOf2>
          </relatedInvestigation>
                </outboundRelationship>  
      </investigationEvent>
    </subject>
     ...
  </controlActProcess>
  ...
  </PORR_IN049016UV>  
...
</MCCI_IN200100UV01>

Validation Procedures

17.1.1.1 There is an investigation code.

Code designates the type of investigation and consequently the role played by the report.

17.1.1.2 The investigation code value is "1".

17.1.1.3 WARNING: Display name for investigation code is "initialReport".

17.1.1.4 Class code and mood code are as above.

17.1.1.5 There is a subject control act.

17.1.1.6 Class and mood codes are as above.

17.1.1.7 Code system is 2.16.840.1.113883.3.989.2.1.1.22.

17.1.1.8 There is an assigned entity participating as author.

17.1.1.9 There is a code.

Code designates the type for the first sender of the case.

17.1.1.10 Code system is 2.16.840.1.113883.3.989.2.1.1.3.

17.1.1.11 The code value is either Regulator (1), Other (2), Patient (C16960), Parent (C42709), or Vaccine Administrator (C102430).

17.1.1.12 WARNING: Display name for the first sender of the report type matches the code.

18 Related Reports

18.1 Related Adverse Event Report

<MCCI_IN200100UV01>
...
   <PORR_IN049016UV>
   ...
     <controlActProcess>
      ...
          <subject>
        <investigationEvent>
          <outboundRelationship typeCode="SPRT">
            <relatedInvestigation classCode="INVSTG" moodCode="EVN">
              <code nullFlavor="NA"/>
              <subjectOf2 typeCode="SUBJ">
                <controlActEvent classCode="CACT" moodCode="EVN">
                  <id extension="23345-PHARMA-344" root="2.16.840.1.113883.3.989.2.1.3.2"/>
                  <!--  Identification Number of the Report Which Is Linked to This Report (repeat as necessary)  #1 -->
                </controlActEvent>
              </subjectOf2>
            </relatedInvestigation>
          </outboundRelationship>
                </investigationEvent>
           </subject>
       ...
      </controlActProcess>
    ...
    </PORR_IN049016UV>  
  ...
</MCCI_IN200100UV01>

Validation Procedures

18.1.1.1 There may be one or more related investigations.

18.1.1.2 The null flavor NA is assigned instead of a code value.

18.1.1.3 If related report information is provided, then there is a World Wide Unique Case Identification Number. Id extension is a value provided by the message sender.

18.1.1.4 If related report information is provided, then the identifier root is 2.16.840.1.113883.3.989.2.1.3.2.

18.1.1.5 Investigation event with the same identifier has been previously submitted.

Id conveys the identification number of a report linked to this report.

19 Report Sender

19.1 Information on the Sender

It is relevant to track the parties involved in sending and receiving an adverse event report. This is particularly the case for the report sender. However, this structure can also be used to capture information on the recipient or recipients of a report.

There may be information on the organizational affiliation for the responsible party. The content of this element is discussed in Section19.3Report Responsible Party Details: Responsible Organization.

19.1.1 Report Sender

<MCCI_IN200100UV01>
...
  <PORR_IN049016UV>
...
  <controlActProcess>
  ...
    <subject>
      <investigationEvent>
        <subjectOf1 typeCode="SUBJ"/>
          <controlActEvent classCode="CACT" moodCode="EVN">
                <author typeCode="AUT">
                  <assignedEntity classCode="ASSIGNED">
            <code code="1" codeSystem="2.16.840.1.113883.3.989.2.1.1.7" displayName="Pharmaceutical Company"/>
                    <addr>
                      <streetAddressLine>89 Central Ave</streetAddressLine>
                      <city>Anytown</city>
                      <state>Idaho</state>
                      <postalCode> 01340</postalCode>  
                    </addr>
                    <telecom value="tel:8884562344"/>
                  </assignedEntity>
                </author>
              </controlActEvent>
            </subjectOf2>
          </relatedInvestigation>
        </outboundRelationship>  
      </investigationEvent>
    </subject>
     ...
  </controlActProcess>
  ...
  </PORR_IN049016UV>  
...
</MCCI_IN200100UV01>

Validation Procedures

19.1.1.1 There is an author of the control act.

19.1.1.2 There is a class code as ASSIGNED for the assigned entity.

19.1.1.3 There is an assigned entity code.

19.1.1.4 There is a code value drawn from Table 12: Report Responsible Party Type.

Code designates the type of organization that is providing the report.

Table 12: Report Responsible Party Type

Code Description Namespace OID
1 Pharmaceutical Company 2.16.840.1.113883.3.989.2.1.1.7
2 Regulatory Authority 2.16.840.1.113883.3.989.2.1.1.7
3 Health Professional 2.16.840.1.113883.3.989.2.1.1.7
4 Regional Pharmacovigilance Centre 2.16.840.1.113883.3.989.2.1.1.7
5 WHO collaborating centres for international drug monitoring 2.16.840.1.113883.3.989.2.1.1.7
6 Other (e.g. distributor or other organisation) 2.16.840.1.113883.3.989.2.1.1.7
7 Patient / Consumer
C16960 Patient 2.16.840.1.113883.3.26.1.1
C42709 Parent 2.16.840.1.113883.3.26.1.1
C102430 Vaccine Administrator 2.16.840.1.113883.3.26.1.1

19.1.1.5 Code system is 2.16.840.1.113883.3.989.2.1.1.7.

19.1.1.6 Code system is 2.16.840.1.113883.3.26.1.1.

19.1.1.7 There is an address for the report sender.

19.1.1.8 The address has street address line, city, state and postal code.

19.1.1.9 There is a telephone number for the report sender.

19.1.1.10 There is a fax number for the report sender.

19.1.1.11 There is an email address for the report sender.

19.2 Report Responsible Party Details: Responsible Organization

The reporting organization is captured as the responsible organization for the report.

19.2.1 Responsible Party Name, & Location

<subjectOf1 typeCode="SUBJ">
  <controlActEvent classCode="CACT" moodCode="EVN">
    <author typeCode="AUT">
      <assignedPerson classCode="PSN" determinerCode="INSTANCE">
        <name>
          <prefix>Professor</prefix>                        
          <given>Ronald</given>                        
          <given>Robert</given>                          
          <family>Rhodes</family>                        
        </name>
        <asLocatedEntity classCode="LOCE">
          <location classCode="COUNTRY" determinerCode="INSTANCE">
            <code code="US" codeSystem="1.0.3166.1.2.2"/>
          </location>
        </asLocatedEntity>
      </assignedPerson>                    
    </assignedEntity>
  </author>
</controlActEvent>

Validation Procedures

19.2.1.1 There is name and title information for the sender of the report.

19.2.1.2 There is country location information for the report responsible party.

19.2.1.3 There is a location country code value.

19.2.1.4 Code system is 1.0.3166.1.2.2.

19.2.1.5 If a non-null value is provided, then country code comes from the ISO alpha 2 country code list.

19.3 Report Responsible Party Details: Responsible Organization

The reporting organization is captured as the responsible organization for the report.

19.3.1 Responsible Organization

<controlActEvent>
  <author>
    <assignedEntity>
      <representedOrganization classCode="ORG" determinerCode="INSTANCE">
        <name>Reporting</name>        
        <assignedEntity classCode="ASSIGNED">
          <representedOrganization classCode="ORG" determinerCode="INSTANCE">
            <name>Pharma Company</name>          
          </representedOrganization>
        </assignedEntity>
      </representedOrganization>
    </assignedEntity>
  </author>
</controlActEvent>

Validation Procedures

19.3.1.1 There is an assigned entity organization.

19.3.1.2 Class code and determiner code are as above.

19.3.1.3 There is a name for the report sender department.

19.3.1.4 There is an assigned entity.

Indicates the organization that scopes the responsible organization.

19.3.1.5 Class code and determiner code are as above.

19.3.1.6 There may be a name for the responsible organization.

19.3.1.7 There is a name for the report sender organization.

20 Other Case Report Identifiers

20.1 Identifiers

It is important to take note of the identifiers used for reporting an investigation that were provided in other electronic reports of the case.

20.1.1 Investigation Event

<MCCI_IN200100UV01>
...
   <PORR_IN049016UV>
   ...
     <controlActProcess>
      ...
          <subject>
        <investigationEvent>
          <subjectOf1 typeCode="SUBJ">
            <controlActEvent classCode="CACT" moodCode="EVN">
              <id assigningAuthorityName="Reporting Ltd Corporation" extension="FR-RPTLTD-15998" root="2.16.840.1.113883.3.989.2.1.3.3"/>      
            </controlActEvent>
          </subjectOf1>
        </investigationEvent>
            </subject>
       ...
    </controlActProcess>
    ...
    </PORR_IN049016UV>  
  ...
</MCCI_IN200100UV01>

Validation Procedures

20.1.1.1 There is one or more control acts.

20.1.1.2 Class code and mood code are as above.

20.1.1.3 There may be an identifier for the investigation report; the identification number is a value provided by the message sender.

The identifier is some other identifier used for this case in the past. This may be the identifier assigned by another sender. In rare cases, for example if the company has changed its name or merged with another company, it may be an other identifier used by this company. Note, the format of the identifier is the same as for the Sender's Unique Identifer mentioned above. It is expected that such a value will match a report identifier which has been previously received.

20.1.1.4 The identifier root is 2.16.840.1.113883.3.989.2.1.3.3.

20.1.1.5 Identifier assigning authority name contains the name of the sending organization for the report.

20.1.1.6 If there is no identifier, then nullFlavor "NI" is used.

21 Adverse Event Assessment Observations

21.1 Relevant Data Associated with the Adverse Event Assessment

A range of relevant data associated with the adverse event assessment is captured as observations using this element.

21.1.1 Adverse Event Assessment

<MCCI_IN200100UV01>
...
   <PORR_IN049016UV>
   ...
     <controlActProcess>
      ...
          <subject>
        <investigationEvent>
           <component typeCode="COMP">
            <observationEvent classCode="OBS" moodCode="EVN">
              <code code="1" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" displayName="additionalDocumentsAvailable"/>
              <value xsi:type="BL" value="true"/>      
            </observationEvent>
          </component>
          <component typeCode="COMP">
            <observationEvent classCode="OBS" moodCode="EVN">
              <code code="23" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" displayName="localCriteriaForExpedited"/>
              <value xsi:type="BL" value="true"/>      
            </observationEvent>
          </component>
          <component typeCode="COMP">
            <observationEvent classCode="OBS" moodCode="EVN">
              <code code="36" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" displayName="summaryAndComment"/>
              <value xsi:type="ED" language="H.5.r.1b">H.5.r.1a</value>
              <author typeCode="AUT">
                <assignedEntity classCode="ASSIGNED">
                  <code code="2" codeSystem="2.16.840.1.113883.3.989.2.1.1.21" displayName="reporter"/>
                </assignedEntity>
              </author>
            </observationEvent>
          </component>
        </investigationEvent>
           </subject>
       ...
     </controlActProcess>
    ...
   </PORR_IN049016UV>  
  ...
</MCCI_IN200100UV01> 

Validation Procedures

21.1.1.1 There are one to many observations recording information relevant for the adverse event assessment.

Table 13: Adverse Event Assessment Observations

Code Description Code System OID Value Type Card.
1 additionalDocumentsAvailable 2.16.840.1.113883.3.989.2.1.1.19 BL 1..1
23 localCriteriaForExpedited 2.16.840.1.113883.3.989.2.1.1.19 BL 1..1
36 summaryAndComment 2.16.840.1.113883.3.989.2.1.1.19 ED 0..*
10 comment 2.16.840.1.113883.3.989.2.1.1.19 ED 0..*
15 diagnosis 2.16.840.1.113883.3.989.2.1.1.19 CE 0..*

21.1.1.2 There is an observation recording the availability of new documents (Observation code = 1). Also, if any reference document included (reference/document/code ="1"), then the value is true.

21.1.1.3 There is an observation recording whether a report meets the local criteria for an expedited report (Observation code = 23). If unavailable, the nullflavor "NI" indicates lack of value.

21.1.1.4 Observation class code and mood code are as above.

21.1.1.5 There is an observation code.

There may be one or more component relationships to record the case summary and reporter's comments. Multiple instances are allowed so that comments may be provided in more than one language.

21.1.1.6 The code system is 2.16.840.1.113883.3.989.2.1.1.19.

21.1.1.7 Observation code values are drawn from Table 13: Adverse Event Assessment Observations.

21.1.1.8 WARNING: Display name for the adverse event assessment information matches the code.

21.1.1.9 Value type for observation value is drawn from Table 13: Adverse Event Assessment Observations.

21.1.1.10 Language attribute is valued with the appropriate human language code.

21.1.1.11 The case summary is provided as the content of the value element.

21.1.1.12 Valid values for the language attribute are drawn from the list of language codes documented in Appendix B - ISO Language Codes. Code values are drawn from the ISO 639-2/RA, alpha-3 code system. Language code values are not case sensitive.

Table 14:Supported Language Codes

Code Display Name
eng English
fra French
deu Gernan
spa Spanish
jpn Japanes
por Portuguese

21.1.1.13 There is an assigned entity recorded as author of the observation.

21.1.1.14 Assigned entity code value is Sender (1), Reporter (2), Source Reporter (3).

21.1.1.15 WARNING: Display name for the author of the observation information matches the code.

21.1.1.16 Code system is 2.16.840.1.113883.3.989.2.1.1.21.

21.1.2 Adverse Event Assessment Observations: Diagnosis or Comment

<MCCI_IN200100UV01>
...
   <PORR_IN049016UV>
   ...
     <controlActProcess>
      ...
          <subject>
        <investigationEvent>
            <component>
                <adverseEventAssessment>
                    <component1 typeCode="COMP">
                        <observationEvent classCode="OBS" moodCode="EVN">
                            <code code="10" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" displayName="comment"/>
                            <value xsi:type="ED">It appears very likely that the primary drug is responsible for all the reactions.</value>
                            <!-- Reporter's Comments -->
                            <author typeCode="AUT">
                                <assignedEntity classCode="ASSIGNED">
                                    <code code="3" codeSystem="2.16.840.1.113883.3.989.2.1.1.21" displayName="sourceReporter"/>
                                </assignedEntity>
                            </author>
                        </observationEvent>
                    </component1>
                    <component1 typeCode="COMP">
                        <observationEvent classCode="OBS" moodCode="EVN">
                            <code code="15" codeSystem="2.16.840.1.113883.3.989.2.1.1.19" displayName="diagnosis"/>
                            <value xsi:type="CE" code="10047319" codeSystem="2.16.840.1.113883.6.163" codeSystemVersion="12.0"/>
                            <!-- MedDRA Version for Sender's Diagnosis / Syndrome and / or Reclassification of Reaction / Event #1 -->
                            <!--  Sender's Diagnosis / Syndrome and / or Reclassification of Reaction / Event  (MedDRA code) #1 -->
                            <author typeCode="AUT">
                                <assignedEntity classCode="ASSIGNED">
                                    <code code="1" codeSystem="2.16.840.1.113883.3.989.2.1.1.21" displayName="sender"/>
                                </assignedEntity>
                            </author>
                        </observationEvent>
                    </component1>
                </adverseEventAssessment>    
            </component>
        </investigationEvent>
           </subject>
       ...
     </controlActProcess>
    ...
   </PORR_IN049016UV>  
  ...
</MCCI_IN200100UV01> 

Validation Procedures

21.1.2.1 If there is an observation recording diagnosis (code = 15) or comment (code = 10), then there is an author participation.

21.1.2.2 If there is an observation recording reporter's comment, then code system for observation value is 2.16.840.1.113883.6.163 (MedDRA).

21.1.2.3 There is a code system version.

21.1.2.4 Observation class code and mood code are as above.

21.1.2.5 There is an observation code.

There may be one or more component relationships to record the case summary and reporter's comments. Multiple instances are allowed so that comments may be provided in more than one language.

21.1.2.6 The code system is 2.16.840.1.113883.3.989.2.1.1.19.

21.1.2.7 Observation code values are drawn from Table 13: Adverse Event Assessment Observations.

21.1.2.8 WARNING: Display name matches the code.

21.1.2.9 Value type for observation value is drawn from Table 13: Adverse Event Assessment Observations.

22 Investigation Characteristics

22.1 Observation

A range of relevant data for the investigations are captured as an observation using this element.

22.1.1 Investigation Detail

<MCCI_IN200100UV01>
   ...
 <PORR_IN049016UV>
<controlActProcess>
<subject>
<investigationEvent>
<subjectOf2 typeCode="SUBJ">
<investigationCharacteristic classCode="OBS" moodCode="EVN">
<code code="1" codeSystem="2.16.840.1.113883.3.989.2.1.1.23" displayName="ICH ReportType"/>
<value xsi:type="CE" code="1" codeSystem="2.16.840.1.113883.3.989.2.1.1.2"/>
<!-- Type of Report -->
</investigationCharacteristic>
</subjectOf2>
<subjectOf2 typeCode="SUBJ">
<investigationCharacteristic classCode="OBS" moodCode="EVN">
<code code="2" codeSystem="2.16.840.1.113883.3.989.2.1.1.23" displayName="otherCaseIds"/>
<value xsi:type="BL" value="true"/>
<!-- Other Case Identifiers in Previous Transmissions -->
</investigationCharacteristic>
</subjectOf2>
<subjectOf2 typeCode="SUBJ">
<investigationCharacteristic classCode="OBS" moodCode="EVN">
<code code="3" codeSystem="2.16.840.1.113883.3.989.2.1.1.23" displayName="nullificationAmendmentCode"/>
<value xsi:type="CE" code="C.1.11.1" codeSystem="2.16.840.1.113883.3.989.2.1.1.5"/>
<!--  Report Nullification / Amendment -->
</investigationCharacteristic>
</subjectOf2>
<subjectOf2 typeCode="SUBJ">
<investigationCharacteristic classCode="OBS" moodCode="EVN">
<code code="4" codeSystem="2.16.840.1.113883.3.989.2.1.1.23" displayName="nullificationAmendmentReason"/>
<value xsi:type="CE">
<originalText>A text reason for ammending the document</originalText>
<!--  Reason for Nullification / Amendment -->
</value>
</investigationCharacteristic>
</subjectOf2>
</investigationEvent>
</subject>
</controlActProcess>
</PORR_IN049016UV>
  ...
</MCCI_IN200100UV01>

Validation Procedures

22.1.1.1 There may be one to many observations that record characteristics that are relevant for the investigation.

Table 15: Investigation Characteristic Observations

Code Description Code System OID Value Type Card.
1 ICH ReportType 2.16.840.1.113883.3.989.2.1.1.23 CE 1..1
2 otherCaseIds 2.16.840.1.113883.3.989.2.1.1.23 BL 1..1
3 Nullification/Amendment Code 2.16.840.1.113883.3.989.2.1.1.23 CE 0..1
4 Nullification/Amendment Reason 2.16.840.1.113883.3.989.2.1.1.23 CE 0..1

22.1.1.2 There is an observation recording the ICSR type for the report.

22.1.1.3 There is an observation recording the other Case Ids.

22.1.1.4 Observation class code and mood code are as above.

22.1.1.5 There is a code.

22.1.1.6 Observation code values are drawn from Table 15: Investigation Characteristic Observations.

22.1.1.7 Code system is 2.16.840.1.113883.3.989.2.1.1.23.

22.1.1.8 The data type for observation value is drawn from Table 15: Investigation Characteristic Observations.

22.1.1.9 WARNING: Display name for the investigation characteristic information matches the code.

22.1.1.10 Code value is either Spontaneous report (1), Report from study (2), Other (3), unknown (4).

22.1.1.11 Observation value code system is 2.16.840.1.113883.3.989.2.1.1.2.

22.1.1.12 WARNING: Display name for the report type information matches the code.

22.1.1.13 Code value is either Nullification (1) or Amendment (2).

22.1.1.14 Observation value code system is 2.16.840.1.113883.3.989.2.1.1.5.

22.1.1.15 WARNING: Display name for the nullification/amendment information matches the code.

22.1.1.16 If the value for other Case Ids is true, then there is Other Case Identifiers present.

22.1.1.17 If there are no Other Case Identifiers present, then nullFlavor "NI" is used and if nullFlavor "NI" provided, then there must not be any other case identifiers within the ICSR.

22.1.1.18 Original text is provided.

Appendix A Unit of Measure Value Set

Unit Display Name
% percent
1 1
[Amb'a'1'U] [Amb'a'1'U]
[arb'U] [arb'U]
[AU] [AU]
[BAU] [BAU]
[CCID_50] [CCID_50]
[CFU] [CFU]
[D'ag'U] [D'ag'U]
[drp] drop(s)
[FFU] [FFU]
[hp_C] [hp_C]
[hp_M] [hp_M]
[hp_Q] [hp_Q]
[hp_X] [hp_X]
[IR] [IR]
[iU] internationalunit(s)
[iU]/kg iu/kilogram
[kp_C] [kp_C]
[Lf] [Lf]
[PFU] [PFU]
[PNU] [PNU]
[TCID_50] [TCID_50]
[USP'U] [USP'U]
{decade} Decade
{DF} dosageform
{trimester} Trimester
a Year
Bq becquerel(s)
Ci curie(s)
cm cm
cm2 cm2
d Day
dL dL
g gram(s)
GBq gigabecquerel(s)
h Hour
IU IUinternationalunit(s)
k[iU] iu(1000s)
kbq kilobecquerel(s)
kBq kilobecquerel(s)
kg kilogram(s)
l litre(s)
mCi mCi
meq meq
mg mg
mg/dl mg/dl
min min
M[iU] iu(1,000,000s)
MBq megabecquerel(s)
mCi millicurie(s)
meq milliequivalent(s)
mg milligram(s)
mg/kg milligram(s)/kilogram
mg/m2 milligram(s)/sq.meter
min Minute
mL millilitre(s)
mm mm
mmol millimole(s)
mo Month
mol mole(s)
nCi nanocurie(s)
ng nanogram(s)
nmol nmol
pg picogram(s)
s Second
U U
uCi microcurie(s)
ug microgram(s)
ug/kg microgram(s)/kilogram
ug/m2 microgram(s)/sq.meter
uL microlitre(s)
um um
umol micromole(s)
wk Week

Appendix B ISO Language Codes

Code Display Name
abk Abkhazian
ace Achinese
ach Acoli
ada Adangme
ady Adyghe; Adygei
aar Afar
afh Afrihili
afr Afrikaans
afa Afro-Asiatic languages
ain Ainu
aka Akan
sqi Albanian
ale Aleut
alg Algonquian languages
tut Altaic languages
amh Amharic
anp Angika
apa Apache languages
ara Arabic
arg Aragonese
arp Arapaho
arw Arawak
hye Armenian
rup Aromanian; Arumanian; Macedo-Romanian
art Artificial languages
asm Assamese
ast Asturian; Bable; Leonese; Asturleonese
ath Athapascan languages
aus Australian languages
map Austronesian languages
ava Avaric
awa Awadhi
aym Aymara
aze Azerbaijani
ban Balinese
bat Baltic languages
bal Baluchi
bam Bambara
bai Bamileke languages
bad Banda languages
bnt Bantu languages
bas Basa
bak Bashkir
eus Basque
btk Batak languages
bej Beja; Bedawiyet
bel Belarusian
bem Bemba
ben Bengali
ber Berber languages
bho Bhojpuri
bih Bihari languages
bik Bikol
bin Bini; Edo
bis Bislama
byn Blin; Bilin
zbl Blissymbols; Blissymbolics; Bliss
nob BokmŒl
bos Bosnian
bra Braj
bre Breton
bug Buginese
bul Bulgarian
bua Buriat
mya Burmese
cad Caddo
cat Catalan; Valencian
cau Caucasian languages
ceb Cebuano
cel Celtic languages
cai Central American Indian languages
khm Central Khmer
cmc Chamic languages
cha Chamorro
che Chechen
chr Cherokee
chy Cheyenne
nya Chichewa; Chewa; Nyanja
zho Chinese
chn Chinook jargon
chp Chipewyan; Dene Suline
cho Choctaw
chk Chuukese
chv Chuvash
cor Cornish
cos Corsican
cre Cree
mus Creek
cpe Creoles and pidgins
cpf Creoles and pidgins
cpp Creoles and pidgins
crp Creoles and pidgins
crh Crimean Tatar; Crimean Turkish
hrv Croatian
cus Cushitic languages
ces Czech
dak Dakota
dan Danish
dar Dargwa
del Delaware
din Dinka
div Divehi; Dhivehi; Maldivian
doi Dogri
dgr Dogrib
dra Dravidian languages
dua Duala
nld Dutch; Flemish
dyu Dyula
dzo Dzongkha
frs Eastern Frisian
efi Efik
eka Ekajuk
eng English
myv Erzya
epo Esperanto
est Estonian
ewe Ewe
ewo Ewondo
fan Fang
fat Fanti
fao Faroese
fij Fijian
fil Filipino; Pilipino
fin Finnish
fiu Finno-Ugrian languages
fon Fon
fra French
fur Friulian
ful Fulah
gaa Ga
gla Gaelic; Scottish Gaelic
car Galibi Carib
glg Galician
lug Ganda
gay Gayo
gba Gbaya
kat Georgian
deu German
gem Germanic languages
gil Gilbertese
gon Gondi
gor Gorontalo
grb Grebo
ell Greek
grn Guarani
guj Gujarati
gwi Gwich'in
hai Haida
hat Haitian; Haitian Creole
hau Hausa
haw Hawaiian
heb Hebrew
her Herero
hil Hiligaynon
him Himachali languages; Western Pahari languages
hin Hindi
hmo Hiri Motu
hmn Hmong; Mong
hun Hungarian
hup Hupa
iba Iban
isl Icelandic
ido Ido
ibo Igbo
ijo Ijo languages
ilo Iloko
smn Inari Sami
inc Indic languages
ine Indo-European languages
ind Indonesian
inh Ingush
ina Interlingua (International Auxiliary Language Association)
ile Interlingue; Occidental
iku Inuktitut
ipk Inupiaq
ira Iranian languages
gle Irish
iro Iroquoian languages
ita Italian
jpn Japanese
jav Javanese
jrb Judeo-Arabic
jpr Judeo-Persian
kbd Kabardian
kab Kabyle
kac Kachin; Jingpho
kal Kalaallisut; Greenlandic
xal Kalmyk; Oirat
kam Kamba
kan Kannada
kau Kanuri
krc Karachay-Balkar
kaa Kara-Kalpak
krl Karelian
kar Karen languages
kas Kashmiri
csb Kashubian
kaz Kazakh
kha Khasi
khi Khoisan languages
kik Kikuyu; Gikuyu
kmb Kimbundu
kin Kinyarwanda
kir Kirghiz; Kyrgyz
tlh Klingon; tlhIngan-Hol
kom Komi
kon Kongo
kok Konkani
kor Korean
kos Kosraean
kpe Kpelle
kro Kru languages
kua Kuanyama; Kwanyama
kum Kumyk
kur Kurdish
kru Kurukh
kut Kutenai
lad Ladino
lah Lahnda
lam Lamba
day Land Dayak languages
lao Lao
lav Latvian
lez Lezghian
lim Limburgan; Limburger; Limburgish
lin Lingala
lit Lithuanian
jbo Lojban
nds Low German; Low Saxon; German
dsb Lower Sorbian
loz Lozi
lub Luba-Katanga
lua Luba-Lulua
lui Luiseno
smj Lule Sami
lun Lunda
luo Luo (Kenya and Tanzania)
lus Lushai
ltz Luxembourgish; Letzeburgesch
mkd Macedonian
mad Madurese
mag Magahi
mai Maithili
mak Makasar
mlg Malagasy
msa Malay
mal Malayalam
mlt Maltese
mnc Manchu
mdr Mandar
man Mandingo
mni Manipuri
mno Manobo languages
glv Manx
mri Maori
arn Mapudungun; Mapuche
mar Marathi
chm Mari
mah Marshallese
mwr Marwari
mas Masai
myn Mayan languages
men Mende
mic Mi'kmaq; Micmac
min Minangkabau
mwl Mirandese
moh Mohawk
mdf Moksha
lol Mongo
mon Mongolian
mkh Mon-Khmer languages
mos Mossi
mul Multiple languages
mun Munda languages
nah Nahuatl languages
nau Nauru
nav Navajo; Navaho
nbl Ndebele
nde Ndebele
ndo Ndonga
nap Neapolitan
new Nepal Bhasa; Newari
nep Nepali
nia Nias
nic Niger-Kordofanian languages
ssa Nilo-Saharan languages
niu Niuean
nqo N'Ko
zxx No linguistic content; Not applicable
nog Nogai
nai North American Indian languages
frr Northern Frisian
sme Northern Sami
nor Norwegian
nno Norwegian Nynorsk; Nynorsk
nub Nubian languages
nym Nyamwezi
nyn Nyankole
nyo Nyoro
nzi Nzima
oci Occitan (post 1500)
oji Ojibwa
ori Oriya
orm Oromo
osa Osage
oss Ossetian; Ossetic
oto Otomian languages
pau Palauan
pam Pampanga; Kapampangan
pag Pangasinan
pan Panjabi; Punjabi
pap Papiamento
paa Papuan languages
nso Pedi; Sepedi; Northern Sotho
fas Persian
phi Philippine languages
pon Pohnpeian
pol Polish
por Portuguese
pra Prakrit languages
pus Pushto; Pashto
que Quechua
raj Rajasthani
rap Rapanui
rar Rarotongan; Cook Islands Maori
roa Romance languages
ron Romanian; Moldavian; Moldovan
roh Romansh
rom Romany
run Rundi
rus Russian
sal Salishan languages
smi Sami languages
smo Samoan
sad Sandawe
sag Sango
sat Santali
srd Sardinian
sas Sasak
sco Scots
sel Selkup
sem Semitic languages
srp Serbian
srr Serer
shn Shan
sna Shona
iii Sichuan Yi; Nuosu
scn Sicilian
sid Sidamo
sgn Sign Languages
bla Siksika
snd Sindhi
sin Sinhala; Sinhalese
sit Sino-Tibetan languages
sio Siouan languages
sms Skolt Sami
den Slave (Athapascan)
sla Slavic languages
slk Slovak
slv Slovenian
som Somali
son Songhai languages
snk Soninke
wen Sorbian languages
sot Sotho
sai South American Indian languages
alt Southern Altai
sma Southern Sami
spa Spanish; Castilian
srn Sranan Tongo
suk Sukuma
sun Sundanese
sus Susu
swa Swahili
ssw Swati
swe Swedish
gsw Swiss German; Alemannic; Alsatian
syr Syriac
tgl Tagalog
tah Tahitian
tai Tai languages
tgk Tajik
tmh Tamashek
tam Tamil
tat Tatar
tel Telugu
ter Tereno
tet Tetum
tha Thai
bod Tibetan
tig Tigre
tir Tigrinya
tem Timne
tiv Tiv
tli Tlingit
tpi Tok Pisin
tkl Tokelau
tog Tonga (Nyasa)
ton Tonga (Tonga Islands)
tsi Tsimshian
tso Tsonga
tsn Tswana
tum Tumbuka
tup Tupi languages
tur Turkish
tuk Turkmen
tvl Tuvalu
tyv Tuvinian
twi Twi
udm Udmurt
uig Uighur; Uyghur
ukr Ukrainian
umb Umbundu
mis Uncoded languages
und Undetermined
hsb Upper Sorbian
urd Urdu
uzb Uzbek
vai Vai
ven Venda
vie Vietnamese
vol Volapyk
vot Votic
wak Wakashan languages
wln Walloon
war Waray
was Washo
cym Welsh
fry Western Frisian
wal Wolaitta; Wolaytta
wol Wolof
xho Xhosa
sah Yakut
yao Yao
yap Yapese
yid Yiddish
yor Yoruba
ypk Yupik languages
znd Zande languages
zap Zapotec
zza Zaza; Dimili; Dimli; Kirdki; Kirmanjki; Zazaki
zen Zenaga
zha Zhuang; Chuang
zul Zulu
zun Zuni