To justify collection of AP data, some sort of a relationship is necessary between the associated person and a study, a subject, or a device. However, a single value in SREL is inadequate to describe relationships to multiple subjects or devices and/or multiple relationships to a single subject or device. In such cases, the value MULTIPLE should appear in SREL. MULTIPLE may also appear in RSUBJID to describe relationships with multiple subjects. When other SDTM variables are populated with MULTIPLE, the multiple values are stored in supplemental qualifiers.
However, this approach has been found to be an indirect and cumbersome way to handle multiple associated person-subject relationships. In addition, when there is AP data in multiple domains, the supplemental qualifier approach would require the same set of supplemental qualifiers to be repeated for each domain. The APRELSUB dataset, which parallels the structure of the RELSUB dataset, was created as a more efficient and simpler way to record these multiple relationships. The APRELSUB dataset is required for studies in which SREL values of MULTIPLE appear, but would not be needed if each associated person has only 1 relationship to a study, a subject, or a device.
APRELSUB Dataset
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 | 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). | ||||||
| 3 | RSUBJID | Related Subject or Pool Identifier | Char | Identifier | Identifier for a related subject or pool of subjects. RSUBJID may be populated with the USUBJID of the related subject or the POOLID of the related pool. RSUBJID will be null for data about associated persons who are related to the study but not to any study subjects. | ||||||
| 4 | RDEVID | Related Device Identifier | Char | Identifier | Identifier for a related device. RDEVID will be populated with the SPDEVID of the related device. | ||||||
| 5 | SREL | Subject, Device, or Study Relationship | Char | Record Qualifier | If RSUBJID is populated, describes the relationship of the associated person(s) identified in APID to the subject or pool identified in RSUBJID. If RDEVID is populated, describes the relationship of the associated person(s) identified in APID to the subject or pool identified in RDEVID. If RSUBJID and RDEVID are null, SREL describes the relationship of the associated person(s) identified in APID to the study identified in STUDYID. |
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