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 This is an example CRF that collected information on previous medically recognized products used to reduce nicotine dependency at the baseline visit. The applicant only collected details on the last attempt to reduce nicotine dependency for each type of product used.

OrderQuestion TextPromptCase Report Form Completion InstructionsTypeCollection VariableTabulation Target  Mapping Instructions  Controlled Terminology CodeList NamePermissible ValuesPre-Populated Value
1What was the medication name? Medication
TextCMTRTCMTRT


DRUG USED IN  NICOTINE DEPENDENCE
2
Pre-Specified Intervention
TextCMPRESPCMPRESP


Y
3Did the subject previously use medications to reduce nicotine dependency?Any Medications Taken For Nicotine DependencyIndicate if the subject had used any medically acceptable products to attempt to reduce nicotine dependencyTextCMOCCURCMOCCUR
(NY)Yes; No
4How many times did the subject attempt to use a medicaiton to reduce nicotine dependencyTimes the Subject Attempted to Reduce Nicotine DependencyRecord the number of times a subject attempted to use a medicaiton to reduce nicotine dependencyTextFAORRESFAORRESFAORRES where FAOBJ ="MEDICATION USED IN NICOTINE DEPENDENCE" and FATEST= Total Number "


5What iwas the category?Category
TextFACAT FACAT


ATTEMPTS TO REDUCE NICOTINE DEPENDENCE
OrderQuestion TextPromptCase Report Form Completion InstructionsTypeCollection VariableTabulation Target  Mapping Instructions  Controlled Terminology CodeList NamePermissible ValuesPre-Populated Value
6What was the medication name? Medication
TextCMTRTCMCAT

NICOTINE REPLACEMENT THERAPY: DRUG USED IN REDUCING NICOTINE DEPENDENCE OTHER THAN NRTS  




2
Pre-Specified Intervention
TextCMPRESPCMSCAT


LAST ATTEMPTED USE WITH THIS MEDICATION
3Did the subject previously use medications to reduce nicotine dependency?Any Medications Taken For Nicotine DependencyIndicate if the subject had used any medically acceptable products to attempt to reduce nicotine dependencyTextCMOCCURCMTRT



4How many times did the subject attempt to use a medication to reduce nicotine dependency.Times the Subject Attempted to Reduce Nicotine DependencyRecord the number of times a subject attempted to use a medication to reduce nicotine dependencyTextFAORRESCMDUR



5What is the category of the medication the subject used to attempt to reduce nicotine dependency? Medication CategoryRecord the type of medication the subject used to reduce nicotine dependency.TextFACATCMDUR
DAYS; MONTHS; YEARS

6What is the category of the medication the subject used to attempt to reduce nicotine dependency? Medication CategoryRecord the type of medication the subject used to reduce nicotine dependency.CMCATCMCATCMCAT

NICOTINE REPLACEMENT THERAPY; DRUG USED IN REDUCING NICOTINE DEPENDENCE OTHER THAN NRTS;  




7What is the subcategory for the medication?Medication SubcategoryRecord the medication subcategory, if not pre-printed on the CRF.CMSCATCMSCATCMSCAT


LAST ATTEMPTED USE WITH THIS MEDICATION
8What was the name of the medication the subject used to reduce nicotine dependency? 

 MedicationRecord only one medication per line. Provide the full trade or proprietary name of the medication; otherwise, record the generic name.CMTRTCMTRTCMTRT



9What was the duration of the medication used to reduce nicotine dependency for the last attempt?  Collected DurationProvide the duration of the medication used. CMCDURCMDURCMCDUR



10What was the duration unit of the medication used to reduce nicotine dependency for the last attempt?   Collected Duration UnitSelect the appropriate duration unit of the medication used. CMCDURUCMDURCMCDURU
DAYS; MONTHS; YEARS

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