CDASH Example.Recreational Products Used

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 datset. In order to save space, some of the permissible values are only shown in the metadata specifications.

Section 1 The metadata/specification in the first section focus on the whether any recreational products were used.

Order	Question Text	Prompt	Case Report Form Completion Instructions	Type	Collection Variable	Tabulation Target	Mapping Instructions	Controlled Terminology CodeList Name	Permissible Values
1	What is the category of the substance used?	Substance Use Category	Record the recreational product category, if not pre-printed on the CRF.	Text	SUCAT				RECREATIONAL PRODUCT
2	Were any recreational products used?	Any Recreational Product Used	Indicate if the subject had used any recreational products.	Text	SUYN		SUSTAT = "NOT DONE" and SUTRT="RECREATIOAL PRODUCT" where SUYN = "Not Done"	(NY)	Yes; No; Not Done
3	What was the reason the recreational product use was not done?	Reason Not Done	Record the reason recreational product use was not done.	Text	SUREASND	SUREASND

Section 2 The metadata/specification in the second section focus on each recreational product used.

Order	Question Text	Prompt	Case Report Form Completion Instructions	Type	Collection Variable	Tabulation Target	Mapping Instructions	Permissible Values	Pre-Populated Value
4	What was the recreational product used?	Type of Recreational Product Used	Record each recreational product used on a new line.	Text	SUTRT			Alcohol; Tobacco; Marijuana; Hallucinogen Drugs; Non-medical prescription drugs use; Stimulants; Other
5	Does the subject currently use or formerly used recreational products?	Usage	Check the appropriate box to indicate if the subject currently or formerly used recreational products.	Text	SUNCF	SUSTTPT; SUSTRTPT; SUENTPT; SUENRTPT; SUPRESP		(NCF)	FORMERLY:CURRENT;
6	What was the amount of the recreational product used?	Amount	Indicate the amount of recreational drug the subject consumes on a regular basis.	Text	SUDOSE; SUDOSTXT
7	SUDOSU	What was the unit?	Record the unit. See the protocol for a list of units.	Text	SUDOSU	SUDOSU	(UNIT)
8	SUDOSFRQ	What was the frequency of recreational product use?	Record how often the subject regularly uses the recreational product.	Text	SUDOSFRQ		(FREQ)	Occasionally; Intermittent; Daily; PRN; Unknown

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CDASH Example.Recreational Products Used