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This is an example of a clinical trial where the sponsor collected information on previous products used to reduce nicotine dependency. These products are considered medically acceptable drugs and were represented in the Concomitant Medication (CM) domain. 


Modelling of this information needs discussion at ISMT. 

Panel
Panel
title SMOKING CESSATION PRODUCT
Xformpusher
CDASH VariableOrderQuestion TextPromptCRF Completion InstructionsTypeSDTMIG Target VariableSDTMIG Target MappingControlled Terminology Code List NamePermissible ValuesPre-Populated ValueQuery DisplayList StyleHidden
CMCAT1What is the category of the substance used?

TextCMCAT


DRUG  USED IN  NICOTINE DEPENDENCE


CMYN2Did the subject previously use any medically acceptable products to attempted to quit smoking?
Indicate if the subject had used any medically acceptable products to attempted to quit smokingTextCMOCCURCMOCCUR where CMTRT= "Drug used in nicotine dependence" (NY)Yes; No



FAORRES3How many times did the subject attempt to quit smoking using a smocking cessation product? Times the subject attempted to quit smoking Record the number of times a subject attempt to quit smoking. TextFAORRESFAORRES where FAOBJ ="Drug used in nicotine dependence"  and FATEST= NUMBER OF ATTEMPTS TP QUIT"

RECORD  THE INFORMATION FOR THE  LAST ATTEMPT TO QUIT FOR EACH TYPE OF PRODUCT USED. 









COMBINATION USE OF PRODUCTS???Record the information for the last attempt to quit for each type of product used. 

Xformpusher
CMDOSFRQCMDOSFRQ
CDASH VariableOrderQuestion TextPromptCRF Completion InstructionsTypeSDTMIG Target VariableSDTMIG Target MappingControlled Terminology Code List NamePermissible ValuesPre-Populated ValueQuery DisplayList StyleHidden
CMCAT1What is the category of the substance used?


CMCAT


DRUG USED IN  NICOTINE DEPENDENCE


CMSCAT3What is the type of product the subject used to attempted to quit smoking? Substance Use CategoryRecord the type of product the subject used to attempted to quit smoking. TextCMSCAT

Nicotine Replacement
Therapy (NRT);

Pharmaceuticals
other than NRTs; 

Other
Smoking Cessation aids







CMTRT4What was the  name of the product the subject used to attempted to quit smoking? 



TextCMTRTCMDSTXT5What was the amount of product used to quit smoking? AmountIndicate the amount of amount of tobacco product used to quit smoking? TextCMDOSE; CMDOSTXTPrompt






CMDUR6What was the duration of the product usage to quit smoking?  DurationProvide the duration of the substance use TextCMDUR



Prompt

CMCDURU7What was the duration unit of the product used to quit smoking?  UnitSelect the appropriate duration unit of the  tobacco product usedTextCMDURCMDURU

DAYS; MONTHS; YEARSPrompt

CMDOSFRQ

8What was the frequency of  of the  product used to quit smokingFrequencyText (FREQ)QD; EVERY WEEK; QM; PA
Prompt

Dataset wrap
Rowcaps
Row 1:  Row 2:Row 3:Row 4:Shows whether the subject has used any products to help with nicotine dependence.  These include nicotine replacement therapies and pharmaceuticals  drugs like Varenicline.  The sponsor assigned CMTRT to the name used in the WHO dictionary for these products.  CMDTC is the date this assessment was made.   
Rows 2-6 :Show the various smoking cessation products products that were used by subjects.  CMDUR is the collected duration of the product use. This is used only if collected on the CRF and not derived from start and end date/times. CMDUR is provided using ISO 8601 duration notation.  Row 5:Row 6:Row 7:



Dataset2
Y
RowSTUDYIDDOMAINUSUBJIDCMSEQCMTRTCMCATCMSCATCMPRESPCMOCCURCMDOSECMDTCCMDOSUCMDOSFRQCMDOSFRMCMSTDTCCMENDTCCMSTTPTCMSTRTPTCMENTPTCMENRTPTCMDUR
11234CM12340051DRUG  DRUG USED IN  NICOTINE DEPENDENCE 

YY20062008-01-01BEFORE2006-01-01ONGOING08-08
21234CM12340052Nicotine patchDRUG  USED IN  NICOTINE DEPENDENCE NICOTINE REPLACEMENT  THERAPY YY14PATCHQDPATCH2006-01-012006-01-01THERAPY  LAST ATTEMPT WITH THIS PRODUCT


P2M
31234CM12340061Nicotine gumDRUG  USED IN  NICOTINE DEPENDENCENICOTINE REPLACEMENT  THERAPY YY1PACKQD20032006-03-15BEFORELAST ATTEMPT WITH THIS PRODUCT


P3M
41234CM12340062Nicotine lozenges:DRUG  USED IN  NICOTINE DEPENDENCENICOTINE REPLACEMENT  THERAPY YY1CUPQD2006-03-152006-03-15LAST ATTEMPT WITH THIS PRODUCT


P2W
51234CM12340063bupropionDRUG  USED IN  NICOTINE DEPENDENCEPharmaceuticals
other than NRTs		YY2CUPQD2006-03-152006-03-15BupropionSMOKING CESSATION PHARMCEUTICALS  OTHER THAN NRTSLAST ATTEMPT WITH THIS PRODUCT


P1M
61234CM12340071ChantixDRUG  USED IN  NICOTINE DEPENDENCEPharmaceuticals
other than NRTs		VareniclineSMOKING CESSATION PHARMCEUTICALS  OTHER THAN NRTSLAST ATTEMPT WITH THIS PRODUCT


P40D

FACM was used to represent the number of times the subject attempt to quit smoking using a medically acceptable smoking cessation product.

Dataset wrap
Namefasufacm



Rowcaps
Rows 1, 6, 11:Rows 2-5, 7-10, 12-15:
Dataset2
RowSTUDYIDDOMAINUSUBJIDFASEQFASPIDFATESTCDFATESTFAOBJFACATFAORRESFASTRESCFADTCFATPTFATPTNUMFAELTMFATPTREF
1ABCFAABC-123190567
NUMBER NRTDRUG USED IN  NICOTINE DEPENDENCE TOBACCO CESSATION ATTEMPTS10102007-05-165M PRE-DOSE1-PT5MDOSING2ABCFAABC-123290567OCCURAGE STARTED SMOKING ( Or Tobacco Product)  DAILY16162007-05-165M PRE-DOSE1-PT5MDOSING
3ABCFAABC-123390567OCCURNUMBERPHARMACUETIALTOBACCO CESSATION ATTEMPTSNN2007-05-165M PRE-DOSE1-PT5MDOSING
4ABCFAABC-123490567OCCUROccurrence IndicatorYY2007-05-165M PRE-DOSE1-PT5MDOSING5ABCFAABC-123

5

90567OCCUROccurrence IndicatorYY2007-05-165M PRE-DOSE1-PT5MDOSING