SDTM v2.1 Metadata Check for Class and Dataset Specification Table Beta 1
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| # | 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 | 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 | Identifying variable in the parent dataset that identifies the related record(s). | --SEQ, --GRPID | |||||
| 8 | IDVARVAL | Identifying Variable Value | Char | Identifier | Value of identifying variable of the parent record(s). | ||||||
| 9 | QNAM | Qualifier Variable Name | Char | Topic | The short name of the qualifier variable, which is used as a column name in a domain view with data from the parent domain. The value in QNAM cannot be longer than 8 characters, nor can it start with a number (e.g., "1TEST"). QNAM cannot contain characters other than letters, numbers, or underscores. This will often be the column name in the sponsor's operational dataset. QNAM should not be the name of any standard ADaM variable. | ||||||
| 10 | QLABEL | Qualifier Variable Label | Char | Synonym Qualifier | QNAM | This is the long name or label associated with QNAM. The value in QLABEL cannot be longer than 40 characters. This will often be the column label in the sponsor's original dataset. | |||||
| 11 | QVAL | Data Value | Char | Result Qualifier | Result of, response to, or value associated with QNAM. A value for this column is required; no records can be in a SUPP-- dataset with a null value for QVAL. | ||||||
| 12 | QORIG | Origin | Char | Record Qualifier | Because QVAL can represent a mixture of collected (on a CRF), derived, or assigned items, QORIG is used to indicate the origin of this data. | ||||||
| 13 | QEVAL | Evaluator | Char | Record Qualifier | Used only for results that are subjective (e.g., assigned by a person or a group). Should be null for records that contain objectively collected or derived data. | "ADJUDICATION COMMITTEE", "STATISTICIAN", "DATABASE ADMINISTRATOR", "CLINICAL COORDINATOR" |
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