You are viewing an old version of this page. View the current version.

Compare with Current View Page History

« Previous Version 11 Next »

This CRF collects general history about recreational products used. There are 2 sections in this example. 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 subject that did not use recreational products in the SDTM datset.  


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

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.TextN/ASUSTAT = "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. 

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.TextSUOCCUR; SUSTRTPT; SUSTRF; SUENRTPT; SUENRFSUOCCUR = "Y" WHEN SUNCF = "CURRENT".  SUOCCUR = "Y" WHEN SUNCF = "FORMER".
(NCF)Current; Former
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)


6SUDOSFRQWhat was the frequency of recreational product use?Record how often the subject regularly uses the recreational product.TextSUDOSFRQ
(FREQ)
Occasionally; Intermittent; Daily; PRN; Unknown

  • No labels