CDASH RYZE Example.Products Used For Smoking Cessation

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

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; CMPRESP		(NY)	Yes; No

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
3	What was the smoking cessation product used?	Smoking Cessation Product	Select the smoking cessation product.	Text	CMTRT	CMTRT; 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 Used	For each product indicate if the product was used.	Text	CMOCCUR	CMOCCUR		Yes No
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	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	If Yes then CMRSDISC = "ADVERSE EXPERIENCE"	(NY)	Yes; No
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.	CMENDAT	CMENDTC

Page tree

CDASH RYZE Example.Products Used For Smoking Cessation