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Shareqc_send4tig10_ds |
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Class | Special Purpose |
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Domain | CO |
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This is a copy from v3.1.1
Metadataspec |
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highlight | true |
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keys | Notes;Core;Description | 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. | Req | DOMAIN | Domain Abbreviation | Char | CO | Identifier | Two-character abbreviation for the domain. | Req | RDOMAIN | Related Domain Abbreviation | Char |
| Record Qualifier | Domain abbreviation of the parent record(s). Null for comments collected as a general comment or additional information. | Exp | USUBJID | Unique Subject Identifier | Char |
| Identifier | Identifier used to uniquely identify a subject across all studies for all applications or submissions involving the product. Either USUBJID or POOLID must be populated unless the record contains a study comment unrelated to a USUBJID or POOLID. | Exp | POOLID | Pool Identifier | Char |
| Identifier | Identifier used for pooled subjects to assign a single result to multiple subjects. Either USUBJID or POOLID must be populated unless the record contains a study comment unrelated to a USUBJID or POOLID. | Perm | COSEQ | Sequence Number | Num |
| Identifier | The sequence number must be unique for each record within a USUBJID or POOLID, whichever applies for the record. | Req | IDVAR | Identifying Variable | Char |
| Record Qualifier | Variable in the parent dataset that identifies the record(s) to which the comment applies, which is contained in IDVAR. Examples: BWSEQ or CLGRPID. Used only when individual comments are related to domain records. | Exp | IDVARVAL | Identifying Variable Value | Char |
| Record Qualifier | Value of identifying variable of the parent record(s). Used only when individual comments are related to domain records. Cannot be populated if IDVAR is null. | Exp | COREF | Comment Reference | Char |
| Record Qualifier | | Sponsordefined reference defined reference associated with the comment. May be the logbook page number, name (e.g., Logbook), or a combination of information that identifies the reference (e.g., |
| LogbookLogbook, page 650, Day 28, morning). | Perm | COVAL | Comment | Char |
| Topic | The text of the comment. Text over 200 characters can be added to additional columns COVAL1-COVALn. |
| See Assumption 4 in Section 5.2.1.1. | Req | COEVAL | Evaluator | Char |
| Record Qualifier | Used to describe the originator of the comment. Examples: TECHNICIAN, STUDY DIRECTOR, VET. | Perm | CODTC | Date/Time of Comment | Char | ISO 8601 datetime or interval | Timing | Date/Time of the comment, in ISO 8601 format. May be null if this is a child record of another domain or if the comment date was not collected. In all other cases, this represents the date/time of the comment in ISO 8601 format. | Exp | CODY | Study Day of Comment | Num |
| Timing | Study day of the comment, in integer days. May be null if this is a child record of another domain or if the comment date was not collected. The algorithm for calculations must be relative to the |
| sponsorapplicant-defined RFSTDTC variable in the Demographics (DM) domain. | Perm |
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