The Challenge Agent Characterization dataset allows the sponsor to provide information about challenge agents used in a trial in a structured format. Each record in the Challenge Agent Characterization dataset contains a parameter (a characteristic of the challenge agent) and its value. 

Challenge Agent CharacterizationOne Record per Challenge Agent Characterization Parameter Instance

SDTM v2.1 Metadata Check for Class and Dataset Specification Table Beta 1

Metadata check macro is applied and detected no issues. This notice is provided as a visual reminder. It will be removed during final publication. Release Notes

#Variable NameVariable LabelTypeFormatRoleVariable(s) QualifiedUsage RestrictionsVariable C-codeDefinitionNotes
Examples
1STUDYIDStudy IdentifierChar
Identifier

C83082

A sequence of characters used by the sponsor to uniquely identify the study.



2DOMAINDomain AbbreviationChar
Identifier

C49558

An abbreviation for a collection of observations, with a topic-specific commonality.

2-character abbreviation, which must be "AC".


3ACSEQSequence NumberNum
Identifier



Sequence number given to ensure uniqueness within a dataset. Allows inclusion of multiple records for the same ACPARMCD.


4ACGRPIDGroup IDChar
Identifier



Used to tie together a group of related records.
5ACPARMCDChallenge Agent Parameter Short NameChar
Topic



ACPARMCD (the companion to ACPARM) is limited to 8 characters and does not have special character restrictions. These values should be short for ease of use in programming, but it is not expected that ACPARMCD will need to serve as variable names.


6ACPARMChallenge Agent ParameterChar
Synonym QualifierACPARMCD


Term for the challenge agent characterization parameter. The value in ACPARM cannot be longer than 40 characters.


7ACVALParameter ValueChar
Result Qualifier



Value of ACPARM.
8ACVALUParameter UnitsChar
Variable QualifierACVAL


Units for the value in ACVAL, if applicable.
9ACVALNF

Parameter Null Flavor

Char
Result Qualifier



Null flavor for the value of ACPARM, to be populated if and only if ACVAL is null.


10ACVALCD

Parameter Value Code

Char
Result Qualifier



This is the code of the term in ACVAL.


11ACVCDREF

Name of the Reference Terminology

Char
Result Qualifier



The name of the reference terminology from which ACVALCD is taken.

"CDISC," "ISO 8601"
12ACVCDVER

Version of the Reference Terminology

Char
Result Qualifier



The version number of the reference terminology cited in ACVCDREF, if applicable.



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