Page History

Observations about study subjects are represented in a series of domain datasets for which there will generally be a single dataset for each domain. 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).

Data represented in SDTM datasets include data as originally collected or received, data from the protocol, assigned data, and derived data. 

...

• .

...