Recreational and Tobacco Product Usage

The Interventions domains in SDTM capture investigational, therapeutic, and other treatments 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 SDTM 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.

Example

Unable to render {include} The included page could not be found.

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.

Row 1:	Shows that the subject was using cigarettes before the baseline visit and was expected to continue to use cigarettes after the baseline visit, The baseline visit occurred on 2006-01-01. This is represented using SUSTTPT, SUSTRTPT, SUENTPT and SUENRTPT. SUPRESP is used to indicate that the use of cigarettes was solicited on the CRF.
Row 2:	Shows the subject uses marijuana starting in 2002 and stopped using it on the day of the baseline visit. SUPRESP is used to indicate that the use of marijuana was solicited on the CRF.
Row 3:	Subject 1234006 is a former smoker. The date this subject began smoking is unknown, but it was sometime before the assessment date; this is shown by the values of SUSTTPT and SUSTRTPT. The end date of smoking was collected, so SUENTPT and SUENRTPT are not populated. Instead, the end date is in SUENDTC.
Row 4:	Shows the subjects had missing data for the usage of recreational products; this is indicated by SUSTAT = "NOT DONE". The reason is in SUREASND.

$titleHtml

su.xpt

Row	STUDYID	DOMAIN	USUBJID	SUSEQ	SUTRT	SUCAT	SUPRESP	SUSTAT	SUREASND	SUDOSE	SUDOSU	SUDOSFRQ	SUSTDTC	SUENDTC	SUSTRTPT	SUSTTPT	SUENRTPT	SUENTPT
1	1234	SU	1234005	1	CIGARETTES	RECREATIONAL PRODUCT	Y			2	PACK	QD			BEFORE	2006-01-01	ONGOING	2006-01-01
2	1234	SU	1234005	2	MARIJUNA	RECREATIONAL PRODUCT	Y						2002	2006-01-01
3	1234	SU	1234006	1	CIGARETTES	RECREATIONAL PRODUCT	Y			1	PACK	QD		2003	BEFORE	2006-03-15
4	1234	SU	1234007	1	RECREATIONAL PRODUCT	RECREATIONAL PRODUCT		NOT DONE	Subject left office before CRF was completed

$warningHtml

Dataset Wrapper Debug Message

Please add a row column to your dataset.

Example

This example CRF has 2 sections: Questions in the first section focus on whether any smoking cessation product has been used, and the questions in the second section collect each individual product used. In order to save space, some of the permissible values are only shown in the metadata specifications.

Section 1

Order	Question Text	Prompt	Case Report Form Completion Instructions	Type	Collection Variable	Tabulation Target	Mapping Instructions	Controlled Terminology CodeList Name	Permissible Values	Pre-Populated Value
1	What is the category for the medication?	Concomitant Medication Category		Text	CMCAT					SMOKING CESSATION PRODUCT
2	Were any smoking cessation products taken?	Any Smoking Cessation Products Taken	Indicate if the subject took any smoking cessation products If yes, include the appropriate details where indicated on the CRF.	Text	CMOCCUR	CMOCCUR;		(NY)	No;Yes

Section 2 For each smoking cessation product. If multiple other products are used, create a row for each other product.

Order	Question Text	Prompt	Case Report Form Completion Instructions	Type	Collection Variable	Tabulation Target	Mapping Instructions	Controlled Terminology CodeList Name	Permissible Values
3	What was the smoking cessation product used?	Smoking Cessation Product	Select the smoking cessation product.	Text	CMTRT	CMTRT	CMTRT; CMPRESP; If CMTRT="OTHER" Then CMTRT and CMPRESP are NULL.		NICOTINE PATCH; NICOTINE GUM; NICOTINE LOZENGE; NICOTINE INHALER; VARENICLINE; BUPROPION; OTHER
4	Did the subject previously use the selected medication/product for smoking cessation?	Smoking Cessation Product Used	Indicate if the subject had used the selected smoking cessation product	Text	CMOCCUR	CMOCCUR		(NY)	No; Yes
5	What was the name of the other smoking cessation product used?	Smoking Cessation Product Other	Indicate the Other type of product previously used.	Text	CMTRTO	CMTRT
6	Was the smoking cessation product discontinued due to an adverse experience?	Reason Smoking Cessation Product Discontinued	Indicate if the product was discontinued due to an Adverse Experience	Text	CMRSDISC	CMRSDISC	If Yes then CMRSDISC = "ADVERSE EXPERIENCE"	(NY)	No:Yes:
7	What was the last date the product was used?	Last Date Smoking Cessation Product Used	Indicate the last date the product was used. If the product was used with the last 14 days, a complete date must be recorded. Otherwise, partial dates can be recorded.	Date	CMENDAT	CMENDTC

Unable to render {include} The included page could not be found.

Example

In this example, the sponsor collected information on previous medically recognized products used to reduce nicotine dependency. These products are represented in the Concomitant Medication (CM) domain. These products are not represented in the SU domaiin. The sponsor assigned CMTRT to the name used in the WHO dictionary for these products.

Unable to render {include} The included page could not be found.

Page tree

Recreational and Tobacco Product Usage