| Shareqc_send4tig10_ds |
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| Class | Trial Design |
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| Domain | TS |
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| Variable Name | Variable Label | Type | Controlled Terms, Codelist, or Format | Role | CDISC Notes | Core |
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STUDYID | Study Identifier | Char |
| Identifier | Unique identifier for a study within the submission. | Req |
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| GNTXAID | Genetic Toxicology Assay Identifier | Char | Identifier | 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 |
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sponsorapplicant-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 |
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Section 7Section 7.6.3 that lists all defined parameters. TSVAL can only be null if TSVALNF is populated. | Exp | TSVALNF | Parameter Null Flavor | Char |
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(NULLFLAVOR)ISO 21090 NullFlavor | Record Qualifier | Null flavor for the value of |
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the TSPARMs which should be included according to the trial summary code table below if and to be populated only if TSVAL is null. | Perm |
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