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This is an example CRF used to collect information on prior use of smoking cessation products. The reason why a product was discontinued and any use in the last 14 days was of interest. .    

Xformpusher
OrderCDASH VariableQuestion TextPromptCRF Completion InstructionsTypeSDTMIG TargetSDTMIG Target MappingControlled Terminology Code List NamePermissible ValuesPre-Populated ValueQuery DisplayList StyleHidden
1CMOCCURWere any smoking cessation products  taken?Any Smoking Cessation Products  Indicate if the subject took any smoking cessation products  If Yes, include the appropriate details where indicated on the CRF.TextN/ACMOCCUR(NY)Yes; No



For each product previously taken record the appropriate details below.

Xformpusher
.


OrderCDASH VariableQuestion TextPromptCRF Completion InstructionsTypeSDTMIG TargetSDTMIG Target MappingControlled Terminology Code List NamePermissible ValuesPre-Populated ValueQuery DisplayList StyleHidden
1CMCATWhat is the category for the medication?Concomitant Medication Category
TextCMCAT


SMOKING CESSATION PRODUCT

Yes
2CMTRTWhat was the smoking cessation product?Smoking Cessation Product  Indicate the type of  smoking cessation products  previously used. For each product type previously used complete a new line. TextCMTRT
Nicotine Patches; Nicotine Gum;  Nicotine Lozenge; Nicotine Inhaler; Chantix; Zyban ; Other


NICOTINE PATCHES:  NICOTINE GUM;  NICOTINE LOZENGE; NICOTINE INHALER; CHANTIX; ZYBAN; OTHER





3CMTRTOT

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

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






4CMCRSDISWas the  smoking cessation product discontinued due to a  adverse event ?   Reason Smoking Cessation Product DiscontinuedIndicate if the smoking cessation product was discontinued due to a Adverse EventTextCMRSDISCIf Yes then CMRSDISC = "ADVERSE EVENT"(NY)Yes; No



5CMENDTCWas the product used in the last 14 days?


CMENDTC

Yes; No



This is the SDTM date for the date collected above.  

Dataset wrap
Namecm
Rowcaps
Row 1: Shows the subject reported they had not previously used any smoking cessation product. 
Row 2:Shows the subject reported using Nicotine Gum. This gum was used within 14 days of the date of collection.
 
Since the last date of use is not known, CMENDTC
 
describe the beginning and the end of the interval of uncertainty. The dates are
separate them
separated with a solidus, as shown in
the following
the  table.
  
 
Row 3:Shows the subject
reported 
reported the previous use of a nicotine lozenge at Visit 1, which occurred on 2020-02-15.
 
This usage was ended at least 14 days prior to the date of collection. CMENTPT represented the date 14 days prior to the visit 1 date, in this case 2020-
02
04-
12
01. CMENRTPT indicates the usage ended prior to the date in CMENTPT.
Rows 4-6:Show the
subject that used these products. The subject
subjects used the product shown in CMTRT.  Subject ABC-0006 discontinued Zyban for an adverse event.  
Dataset2
RowSTUDYIDDOMAINUSUBJIDCMSEQCMTRTCMCATCMOCCORCMPRESPCMRSDISCCMDTCCMENDTCCMENRTPTCMENTPTCMENRTPT
1ABCCMXYZABC-00011SMOKING CESSATION PRODUCT
N

2020-01-05


2ABCCMABC-0001000221NICOTINE GUMSMOKING CESSATION PRODUCT
Y
2020-02-152020-02-02/2003-02-15

3ABCCMABC-0001000331NICOTINE LOZENGESMOKING CESSATION PRODUCT
Y
2020-0204-15
PRIOR2020-04-02-12PRIOR
4ABCCMABC-000300041NICOTINE INHALERSMOKING CESSATION PRODUCT
Y
2021-04-1620042021-01-07

5ABCCMABC-0003000521ChantixCHANTIXSMOKING CESSATION PRODUCT
Y
20212020-0409-162420042020-0108-07

6ABCCMABC-0003000631ZybanZYBANSMOKING CESSATION PRODUCT
YADVERSE EVENT2021-04-1620042020-01-09