Versions Compared

Old Version 6

changes.mady.by.user Kathleen Mellars

Saved on

compared with

New Version Current

changes.mady.by.user Kathleen Mellars

Saved on

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

This example CRF has 2 sections: Questions in the first section focus on whether any smoking cessation product has been 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. 

Excerpt

Image Added

Expand
titleCDASH CM Metadata Specifications

Section 1 

Controlled Terminology Code List
Metadataspec
OrderQuestion TextPrompt
CRF
Case Report Form Completion InstructionsType
CDASH
Collection Variable
Name 
SDTMIG Target VariableSDTM Target Mapping
Tabulation Target  Mapping Instructions  Controlled Terminology CodeList NamePermissible ValuesPre-Populated Value
1What is the category for the medication?Concomitant Medication Category
CMCAT

TextCMCAT



SMOKING CESSATION PRODUCT
2Were any smoking cessation
products 
products taken?Any Smoking Cessation Products Taken Indicate if the subject took any smoking cessation
products 
products If
Yes
yes, include the appropriate details where indicated on the CRF.
CMOCCUR
TextCMOCCURCMOCCUR;
CMPRESP
 
(NY)
Yes; No
No;Yes

Section 2 For each smoking cessation product. If multiple other products are used, create a row for each other product.  

Metadataspec
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.TextCMTRTCMTRTCMTRT; CMPRESP;
 
If CMTRT="OTHER" Then CMTRT and CMPRESP are NULL.    


NICOTINE PATCH;
 
NICOTINE GUM;
 
NICOTINE LOZENGE; NICOTINE INHALER; VARENICLINE; BUPROPION;
 
OTHER
4
Was the 

Did the subject previously use the selected medication/product for smoking cessation

product  used

?

 

Smoking Cessation Product Used
For each  product  indicate
Indicate if the
product was used.
subject had used the selected smoking cessation productTextCMOCCURCMOCCUR
CMOCCUR

(NY)No; Yes
;No

5

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

Smoking Cessation Product OtherIndicate the Other type of
product 
product previously used. Text
CMTRTOT
CMTRTOCMTRT



6Was the smoking cessation product discontinued due to
a 
an adverse experience?   Reason Smoking Cessation Product DiscontinuedIndicate if the product was discontinued due to
a
an Adverse Experience
CMCRSDIS
TextCMRSDISCCMRSDISCIf Yes then CMRSDISC = "ADVERSE
Experience
EXPERIENCE"(NY)No: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 
If the product was used with the last 14 days, a
complete 
complete date must be recorded. Otherwise, partial dates can be recorded. DateCMENDAT CMENDTC