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This is an example CRF used to collect data  on the previous use of smoking cessation products at the baseline visit. There are 2 sections in this example. The questions in the first section focus on whether any smoking cessation product is 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 

OrderQuestion TextPromptCase Report Form Completion InstructionsTypeCollection VariableTabulation Target  Mapping Instructions  Controlled Terminology CodeList NamePermissible ValuesPre-Populated Value
1What is the category for the medication?Concomitant Medication Category
TextCMCAT



SMOKING CESSATION PRODUCT
2Were 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.TextCMOCCURCMOCCUR; CMPRESP
(NY)Yes; No
Section 2  For each smoking cessation product. If multiple other products are used, create a row for each other product.  
OrderQuestion TextPromptCase Report Form Completion InstructionsTypeCollection VariableTabulation Target  Mapping Instructions  Controlled Terminology CodeList NamePermissible ValuesPre-Populated Value
3What was the smoking cessation product used?Smoking Cessation ProductSelect the smoking cessation product.TextCMTRTCMTRT; CMPRESP; If CMTRT="OTHER" Then CMTRT and CMPRESP are NULL.    

NICOTINE PATCH; NICOTINE GUM; NICOTINE LOZENGE; NICOTINE INHALER; VARENICLINE; BUPROPION; OTHER



4

Was the smoking cessation product used? 

Smoking Cessation Product UsedFor each product indicate if the product was used.TextCMOCCURCMOCCUR
Yes No

5

What was the name of the other smoking cessation product used? 

Smoking Cessation Product OtherIndicate the Other type of product previously used. TextCMTRT




6Was the smoking cessation product discontinued due to an adverse experience?   Reason Smoking Cessation Product DiscontinuedIndicate if the product was discontinued due to an Adverse ExperienceTextCMRSDISCIf Yes then CMRSDISC = "ADVERSE EXPERIENCE"(NY)Yes; No

7What 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. CMENDAT CMENDTC




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