SDTM v2.1 Metadata Check for Class and Dataset Specification Table Beta 1
Metadata check macro is applied and detected no issues. This notice is provided as a visual reminder. It will be removed during final publication. Release Notes
| # | Variable Name | Variable Label | Type | Format | Role | Variable(s) Qualified | Usage Restrictions | Variable C-code | Definition | Notes | Examples |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | STUDYID | Study Identifier | Char | Identifier | C83082 | A sequence of characters used by the sponsor to uniquely identify the study. | |||||
| 2 | RDOMAIN | Related Domain Abbreviation | Char | Identifier | 2-character abbreviation for the domain of the parent record(s). | ||||||
| 3 | USUBJID | Unique Subject Identifier | Char | Identifier | C69256 | A sequence of characters used to uniquely identify a subject across all studies for all applications or submissions involving the product. | |||||
| 4 | APID | Associated Persons Identifier | Char | Identifier | Identifier for a single associated person, a group of associated persons, or a pool of associated persons. If APID identifies a pool, POOLDEF records must exist for each associated person (see Section 6.3, Pool Definition Dataset, and Section 4, Associated Persons Data). | ||||||
| 5 | POOLID | Pool Identifier | Char | Identifier | C117053 | A sequence of characters used to uniquely identify a group of subjects that have been pooled together. | |||||
| 6 | SPDEVID | Sponsor Device Identifier | Char | Identifier | C117060 | A sequence of characters used by the sponsor to uniquely identify a specific device. | |||||
| 7 | IDVAR | Identifying Variable | Char | Identifier | Name of the identifying variable in the general-observation-class dataset that identifies the related record(s). | --SEQ and --GRPID | |||||
| 8 | IDVARVAL | Identifying Variable Value | Char | Identifier | Value of identifying variable described in IDVAR. If --SEQ is the variable being used to describe this record, then the value of --SEQ is entered here. | ||||||
| 9 | RELTYPE | Relationship Type | Char | Record Qualifier | Identifies the hierarchical level of the records in the relationship. Values should be either ONE or MANY. However, values are only necessary when identifying a relationship between datasets. | ||||||
| 10 | RELID | Relationship Identifier | Char | Record Qualifier | RELID value should be unique within the ID variable (e.g., USUBJID, APID, POOLID, SPDEVID) that is the subject of the relationship. All records with this ID variable that have the same RELID are considered related/associated. RELID can be any value the sponsor chooses, and is only meaningful within the RELREC dataset to identify the related/associated domain records. |
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