Subject Characteristics

The CDASHIG SC domain describes protocol-specified characteristics of the study subjects and serves as an extension of the data contained in the Demographics (DM) domain. It is important to note that:

1. Data in this domain are collected only once per subject.
2. SC data are collected once at the beginning of the trial and are not expected to change during the trial.
3. SC contains data such as information about education level, marital status, and national origin.
4. There is extensible CDASHIG Controlled Terminology for SCTEST. These data might be useful, for example, for risk-benefit or quality-of-life analyses, or for subsetting a subject population.
5. The SDTMIG SC domain utilizes a normalized data structure; that is, 1 variable (SCTEST) is used to capture the test name and another variable (SCORRES) is used to capture the result. Subject characteristics are presented as a normalized structure in the CDASHIG metadata table, but implementers using a denormalized structure (1 variable for each test) should create variable names that mirror the SCTESTCDs in controlled terminology.