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Release Notes
Variable Name
Variable Label
Type
Controlled Terms, Codelist, or Format
Role
CDISC Notes
Core
STUDYID
Study Identifier
Char
Identifier
Unique identifier for a study within the submission.
A short sequence of characters that uniquely identifies a genetic toxicology assay within a study.
Perm
DOMAIN
Domain Abbreviation
Char
TS
Identifier
Two-character abbreviation for the domain most relevant to the observation.
Req
TSSEQ
Sequence Number
Num
Identifier
Sequence number used to ensure uniqueness within a TSPARMCD. Allows inclusion of multiple records for the same TSPARMCD, and can be used to join related records.
Req
TSGRPID
Group Identifier
Char
Identifier
Used to tie together a group of related records. This is not the applicant-defined protocol group number.
Term for the trial parameter. Value must be 40 characters or less.
Req
TSVAL
Parameter Value
Char
Result Qualifier
Value of the TS parameter (e.g., "FDA" when TSPARM is GLP Type). The values for some parameters may be subject to controlled terminology. See the Controlled Terms, Codelist, or Format column in Section 7.6.3 that lists all defined parameters. TSVAL can only be null if TSVALNF is populated.
Exp
TSVALNF
Parameter Null Flavor
Char
(NULLFLAVOR)
Record Qualifier
Null flavor for the value of the TSPARMs, which should be included according to the trial summary code table below if and only if TSVAL is null.
Content: For variable GNTXAID, it is either invalid in the Trial Design class domain or not a recognized domain-specific variable
Content: For variable TSVALNF, csodelist NULLFLAVOR is a not a recognized SEND CT short name; or, does not confirm to the convention for specifying codelist