There are many occasions when it is necessary or desirable to represent relationships among datasets or records. The SDTM includes the following relationship datasets:
- Related Records Dataset, which represents 2 types of relationships:
- A relationship between independent records (usually in separate datasets) for a subject (e.g., a concomitant medication taken to treat an adverse event)
- A relationship between 2 (or more) datasets where records of 1 (or more) dataset(s) are related to record(s) in another dataset (or datasets)
- Supplemental Qualifiers Dataset, which represents dependent relationships where data that cannot be represented by a standard variable within a general-observation class dataset record (or records) can be related back to that record
- Pool Definition Dataset, which represents relationships between a subject and a pool of subjects
- Related Subjects Dataset, which represents relationships between study subjects other than membership in a pool.
- Device-subject Relationships Dataset, which represents relationships between devices and study subjects
- Associated Persons Relationships Dataset, which represents relationships between associated person(s) and study subjects
- Related Specimens Dataset, which represents relationships between collected specimens and specimens derived from them
- Related References Dataset, which represents relationships between the design of the study and sources of information represented by REFID, such as trial sets, experimental units, and observational units.
Overview
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