The Interventions general observational class of domains is used to represent investigational, therapeutic, and other products that are administered to the subject (with some actual or expected physiological effect) either as specified by the study protocol (e.g., exposure to study product coincident with the study assessment period (e.g., concomitant medications), or self‑administered by the subject (e.g., use of alcohol, tobacco, or caffeine).
Recreational drugs are chemical substances taken for enjoyment, or leisure purposes, rather than for medical reasons. They are often drugs that are misused or abused or drugs self-administered by the subject. To support standardization, CDISC defined a Substance Use (SU) domain. This domain is used to represent intervention that are Substance Use (SU )interventions used for non-medical purposes and often maybe harmful to the individual or others. These include alcohol, marijuana and tobacco.
Other domains have been established to record other types of interventions. Interventions administered to the subject coincident with the study assessment period are referred to as concomitant medications and represented in the Concomitant/Prior Medications (CM) domain and interventions administered as protocol-specified study products are represented in the Exposure (EX) and Exposure as Collected (EC) domains.
In clinical trials studying tobacco products, tobacco products being used for non-medical purpose will be represented in the SU domain. However, products being used to reduce the usage of these self-administered tobacco products, will be considered either concomitant medications, or the product under study.
Several examples are provided below to illustrate the different ways a subject's history of recreational product usage may be collected in studies. Note, that the Findings About Events or Interventions structure (or "FA structure") is used to represent collected data that are findings about” an event or intervention that cannot be represented within an event or intervention record or as a supplemental qualifier to such a record. Not all findings associated with an event or intervention should be represented in the FA structure.
- The Findings About Events or Interventions (FA–) is a specialization of the Findings general observation class. it shares all qualities and conventions of Findings observations but is specialized by the addition of the --OBJ variable.
Example
This example collects data on all types of recreational products previosuly used by the subject. The sponsor only collected the general type of product used. The actual dates of usage were also not collected. The subject provided the duration of use. Usage of these recreational products are represented in the SU domain.
There are 2 sections of this example CRF: The questions in the first section focus on the whether any recreational products were used, and the questions in the second section are for each recreational product used. The applicant did not include subjects that did not use recreational products in the SDTM dataset. In order to save space, some of the permissible values are only shown in the metadata specifications. 
This is the SDTM dataset used to represent the above collected data. The applicant populated SUPRESP="Y" for all substances specified in the drop-down list on the CRF. Other substances were not considered prespecified.
Dataset Wrapper Debug Message
Please add a row column to your dataset.
Example
This example illustrates how tobacco use history data could be collected. This example does not include tobacco products that are being used as a medically acceptable therapy for smoking cessation. This includes cigarettes, cigars, pipes, chewing tobacco, snus or tobacco pouches, or tobacco dips. The specific brand name of the product was collected. The sponsor collected whether the product was still being used, and if not, the end date of usage. Usage of these products is represented in the SU domain.
The example SDTM datasets used to represent the collected data are shown below. The additional information was represented as findings about events (FASU). For the general questions about tobacco usage, the applicant assigned FAOBJ to "TOBACCO". Otherwise, the name of the tobacco product (SUTRT) associated with the data in the row was represented in FAOBJ. The UPC code was used by the applicant to identify the product. FADTC is the date of collection, in this situation the applicant used the visit date.
SUTRT represents the brand name of the tobacco product. The applicant added the UPC code of the product to the dataset. Some applicants may collect the UPC code on the CRF. The duration was represented using ISO 8601 duration format. The applicant used the first visit date to populate SUSTPT and SUENTPT.
Dataset Wrapper Debug Message
Please add a row column to your dataset.
Overview
Content Tools