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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.

Exp

TSPARMCD

Trial Summary Parameter Short Name

Char

(STSPRMCD)

Topic

Short character value for the trial design characteristic described in TSPARM. Value must be 8 characters or less.

Req

TSPARM

Trial Summary Parameter

Char

(STSPRM)

Synonym Qualifier

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

(NULLFLAV)

ISO 21090 NullFlavor

Record Qualifier

Null flavor for the value of the TSPARMsTSPARM, which should be included according to the trial summary code table below if and to be populated only if TSVAL is null.

Perm