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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.
Req
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
ISO 21090 NullFlavorTOBA-446
-
Getting issue details...STATUS
Record Qualifier
Null flavor for the value of TSPARM, to be populated only if TSVAL is null.