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Description/Overview

Substance Use (SU) is an interventions domain used for substance use when relevant to the assessment of a product. The amount of information collected for the SU domain depends upon regulatory requirements and the applicant's protocol. 

Using collection variable SUNCF with responses of “Never", "Current", and "Former” for each substance-use type, rather than a simple "Yes/No" response is recommended. Based on the wide variability of definitions of use, the specific definitions and timeframes for the SUNCF responses would be applicant/protocol-defined. By using the SUNCF response categories for usage, a number of questions about use and frequency can be collapsed, in turn decreasing the number of data points required in the SU domain. More detailed information about duration, amount, and start and end dates are optionally captured.

Subject Characteristics (SC) is a

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Findings domain that 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 study and are not expected to change during the study.
3. SC contains data such as information about education level, marital status, and national origin.
4. There is extensible 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 tabulation 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 collection metadata table, but implementers using a denormalized structure (1 variable for each test) should create variable names that mirror the SCTESTCDs in controlled terminology.

Specification

Assumptions