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 Characterization—One Record per Challenge Agent Characterization Parameter Instance
SDTM v2.1 Metadata Check for Class and Dataset Specification Table Beta 1
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| # | Variable Name | Variable Label | Type | Format | Role | Variable(s) Qualified | Usage Restrictions | Variable C-code | Definition | Notes | Examples |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | STUDYID | Study Identifier | Char | Identifier | C83082 | A sequence of characters used by the sponsor to uniquely identify the study. | |||||
| 2 | DOMAIN | Domain Abbreviation | Char | Identifier | C49558 | An abbreviation for a collection of observations, with a topic-specific commonality. | 2-character abbreviation, which must be "AC". | ||||
| 3 | ACSEQ | Sequence Number | Num | Identifier | Sequence number given to ensure uniqueness within a dataset. Allows inclusion of multiple records for the same ACPARMCD. | ||||||
| 4 | ACGRPID | Group ID | Char | Identifier | Used to tie together a group of related records. | ||||||
| 5 | ACPARMCD | Challenge Agent Parameter Short Name | Char | 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. | ||||||
| 6 | ACPARM | Challenge Agent Parameter | Char | Synonym Qualifier | ACPARMCD | Term for the challenge agent characterization parameter. The value in ACPARM cannot be longer than 40 characters. | |||||
| 7 | ACVAL | Parameter Value | Char | Result Qualifier | Value of ACPARM. | ||||||
| 8 | ACVALU | Parameter Units | Char | Variable Qualifier | ACVAL | Units for the value in ACVAL, if applicable. | |||||
| 9 | ACVALNF | Parameter Null Flavor | Char | Result Qualifier | Null flavor for the value of ACPARM, to be populated if and only if ACVAL is null. | ||||||
| 10 | ACVALCD | Parameter Value Code | Char | Result Qualifier | This is the code of the term in ACVAL. | ||||||
| 11 | ACVCDREF | Name of the Reference Terminology | Char | Result Qualifier | The name of the reference terminology from which ACVALCD is taken. | "CDISC," "ISO 8601" | |||||
| 12 | ACVCDVER | Version of the Reference Terminology | Char | Result Qualifier | The version number of the reference terminology cited in ACVCDREF, if applicable. |
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