- Created by Lou Ann Kramer, last modified by Anthony Chow on Apr 01, 2024
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TOBA-79 - Getting issue details... STATUS
TOBA-246 - Getting issue details... STATUS
TIG v1.0 Metadata Check for SEND Domain Specification Table Beta 2.1
Metadata check macro is applied. Make sure all Confluence WIKI macros e.g., JIRA, Status, are removed prior to publication. This notice is provided as a visual reminder. It will be removed during final publication. 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. | 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 | ISO 21090 NullFlavor TOBA-446 - Getting issue details... STATUS | Record Qualifier | Null flavor for the value of TSPARM, to be populated only if TSVAL is null. | Perm |
Metadata Checks Debug Messages
- [DEBUG] Current variable is STUDYID
- [DEBUG] Running generic content checks
- [DEBUG] setRootVariable: determining root variable for STUDYID
- [DEBUG] Root variable for STUDYID is STUDYID
- [DEBUG] testValidClassVariable: Checking for TS variable
- [DEBUG] isValidClassVariable is true
- [DEBUG] variableOrder is 2801
- [DEBUG] Running generic content checks
- [DEBUG] Running generic content checks
- [DEBUG] testNumericSdtmVariable: checking STUDYID
- [DEBUG] Running generic content checks
- [DEBUG] Running generic content checks
- [DEBUG] Running generic content checks
- [DEBUG] Running generic content checks
- [DEBUG] Current variable is DOMAIN
- [DEBUG] Running generic content checks
- [DEBUG] setRootVariable: determining root variable for DOMAIN
- [DEBUG] Root variable for DOMAIN is DOMAIN
- [DEBUG] testValidClassVariable: Checking for TS variable
- [DEBUG] isValidClassVariable is true
- [DEBUG] variableOrder is 2802
- [DEBUG] Running generic content checks
- [DEBUG] Running generic content checks
- [DEBUG] testNumericSdtmVariable: checking DOMAIN
- [DEBUG] Running generic content checks
- [DEBUG] Detected domain code that matches the Domain parameter
- [DEBUG] Running generic content checks
- [DEBUG] Running generic content checks
- [DEBUG] Running generic content checks
- [DEBUG] Current variable is TSSEQ
- [DEBUG] Running generic content checks
- [DEBUG] setRootVariable: determining root variable for TSSEQ
- [DEBUG] Root variable for TSSEQ is --SEQ
- [DEBUG] testValidClassVariable: Checking for TS variable
- [DEBUG] isValidClassVariable is true
- [DEBUG] variableOrder is 2803
- [DEBUG] Running generic content checks
- [DEBUG] Running generic content checks
- [DEBUG] testNumericSdtmVariable: checking --SEQ
- [DEBUG] testNumericSdtmVariable: --SEQ is numeric
- [DEBUG] Running generic content checks
- [DEBUG] Running generic content checks
- [DEBUG] Running generic content checks
- [DEBUG] Running generic content checks
- [DEBUG] Current variable is TSGRPID
- [DEBUG] Running generic content checks
- [DEBUG] setRootVariable: determining root variable for TSGRPID
- [DEBUG] Root variable for TSGRPID is --GRPID
- [DEBUG] testValidClassVariable: Checking for TS variable
- [DEBUG] isValidClassVariable is true
- [DEBUG] variableOrder is 2804
- [DEBUG] Running generic content checks
- [DEBUG] Running generic content checks
- [DEBUG] testNumericSdtmVariable: checking --GRPID
- [DEBUG] Running generic content checks
- [DEBUG] Running generic content checks
- [DEBUG] Running generic content checks
- [DEBUG] Running generic content checks
- [DEBUG] Current variable is TSPARMCD
- [DEBUG] Running generic content checks
- [DEBUG] setRootVariable: determining root variable for TSPARMCD
- [DEBUG] Root variable for TSPARMCD is --PARMCD
- [DEBUG] testValidClassVariable: Checking for TS variable
- [DEBUG] isValidClassVariable is true
- [DEBUG] variableOrder is 2805
- [DEBUG] Running generic content checks
- [DEBUG] Running generic content checks
- [DEBUG] testNumericSdtmVariable: checking --PARMCD
- [DEBUG] Running generic content checks
- [DEBUG] Detected STSPRMCD, a valid CT short name
- [DEBUG] Running generic content checks
- [DEBUG] Running generic content checks
- [DEBUG] Running generic content checks
- [DEBUG] Current variable is TSPARM
- [DEBUG] Running generic content checks
- [DEBUG] setRootVariable: determining root variable for TSPARM
- [DEBUG] Root variable for TSPARM is --PARM
- [DEBUG] testValidClassVariable: Checking for TS variable
- [DEBUG] isValidClassVariable is true
- [DEBUG] variableOrder is 2806
- [DEBUG] Running generic content checks
- [DEBUG] Running generic content checks
- [DEBUG] testNumericSdtmVariable: checking --PARM
- [DEBUG] Running generic content checks
- [DEBUG] Detected STSPRM, a valid CT short name
- [DEBUG] Running generic content checks
- [DEBUG] Running generic content checks
- [DEBUG] Running generic content checks
- [DEBUG] Current variable is TSVAL
- [DEBUG] Running generic content checks
- [DEBUG] setRootVariable: determining root variable for TSVAL
- [DEBUG] Root variable for TSVAL is --VAL
- [DEBUG] testValidClassVariable: Checking for TS variable
- [DEBUG] isValidClassVariable is true
- [DEBUG] variableOrder is 2807
- [DEBUG] Running generic content checks
- [DEBUG] Running generic content checks
- [DEBUG] testNumericSdtmVariable: checking --VAL
- [DEBUG] Running generic content checks
- [DEBUG] Running generic content checks
- [DEBUG] Running generic content checks
- [DEBUG] Running generic content checks
- [DEBUG] Current variable is TSVALNF
- [DEBUG] Running generic content checks
- [DEBUG] setRootVariable: determining root variable for TSVALNF
- [DEBUG] Root variable for TSVALNF is --VALNF
- [DEBUG] testValidClassVariable: Checking for TS variable
- [DEBUG] isValidClassVariable is true
- [DEBUG] variableOrder is 2808
- [DEBUG] Running generic content checks
- [DEBUG] Running generic content checks
- [DEBUG] testNumericSdtmVariable: checking --VALNF
- [DEBUG] Running generic content checks
- [DEBUG] Detected ISO 21090 NullFlavor, an allowable external dictionary or standard
- [DEBUG] Running generic content checks
- [DEBUG] Running generic content checks
- [DEBUG] Running generic content checks
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