There are many occasions when it is necessary or desirable to represent relationships among datasets or records. The SDTM includes the following relationship datasets SDTM-787 - Getting issue details... STATUS :
- 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 other sources of information within the study
The implementation guides define specific details and examples for each of these relationships.
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