Observations about study subjects are represented in a series of domain datasets. All datasets are structured as flat files with rows representing observations and columns representing variables. Data represented in datasets will include:
- Data as originally collected or received
- Data from the protocol
- Assigned data
- Derived data
Number of datasets
for which there will generally be a single dataset for each domain.
Dataset naming conventions
Datasets names will reflect the following conventions:
- be a unique 2 to 4 letter character code (RELREC? SUPPQUAL)
- This code, which is stored in the SDTM variable named DOMAIN, is used in 4 ways: as the dataset name, as the value of the DOMAIN variable in that dataset, as a prefix for most variable names in that dataset, and as a value in the RDOMAIN variable in relationship tables (see Section 8, Representing Relationships and Data).
Overview
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