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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. 


Excerpt

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titleCDASH SU Metadata Specifications

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

Metadataspec
OrderQuestion TextPromptCase Report Form Completion InstructionsTypeCollection VariableTabulation Target  Mapping Instructions  Controlled Terminology CodeList NamePermissible ValuesPre-Populated Value
1What is the category of the substance used?Substance Use CategoryRecord the recreational product category, if not pre-printed on the CRF.TextSUCAT


RECREATIONAL PRODUCT 
2Were any recreational products used?Any Recreational Product UsedIndicate if the subject had used any recreational products.TextSUYN
SUSTAT = "NOT DONE" and SUTRT="RECREATIOAL PRODUCT"  where SUYN = "Not Done"  (NY)Yes; No; Not Done
3What was the reason the recreational product use was not done?  Reason Not DoneRecord the reason recreational  product use was not done. TextSUREASNDSUREASND 



 

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

Metadataspec
OrderQuestion TextPromptCase Report Form Completion InstructionsTypeCollection VariableTabulation Target  Mapping Instructions  Controlled Terminology CodeList NamePermissible ValuesPre-Populated Value
4What was the recreational product used?Type of Recreational Product UsedRecord each recreational product used on a new line. TextSUTRT


Alcohol; Tobacco; Marijuana; Hallucinogen Drugs; Non-medical prescription drugs use; Stimulants; Other 



5Does the subject currently use or formerly used recreational products?UsageCheck the appropriate box to indicate if the subject currently or formerly used recreational products.TextSUNCFSUSTTPT; SUSTRTPT; SUENTPT; SUENRTPT; SUPRESP

(NCF)FORMERLY:CURRENT;
6What was the amount of the recreational product used?AmountIndicate the amount of recreational drug the subject consumes on a regular basis.TextSUDOSE; SUDOSTXT




7SUDOSUWhat was the unit?Record the unit. See the protocol for a list of units.TextSUDOSUSUDOSU(UNIT)


8SUDOSFRQWhat was the frequency of recreational product use?Record how often the subject regularly uses the recreational product.TextSUDOSFRQ
(FREQ)
Occasionally; Intermittent; Daily; PRN; Unknown