| Order | CDASH Variable Name | Question Text | Prompt | CRF Completion Instructions |
| SDTMIG Target Variable | SDTM Target Mapping | Controlled Terminology Code List Name | Permissible Values | Pre-Populated Value |
|---|
| 1 | CMTRT | What was the medication name? | Medication |
|
| CMCAT |
|
| NICOTINE REPLACEMENT THERAPY; DRUG USED IN REDUCING NICOTINE DEPENDENCE OTHER THAN NRTS;
|
| | 2 | CMPRESP |
| Pre-Specified Intervention |
|
| CMSCAT |
|
|
| LAST ATTEMPTED USE WITH THIS MEDICATION | | 3 | CMOCCUR | Did the subject previously use medications to reduce nicotine dependency? | Any Medications Taken For Nicotine Dependency | Indicate if the subject had used any medically acceptable products to attempt to reduce nicotine dependency |
| CMTRT |
|
|
|
| | 4 | FAORRES | How many times did the subject attempt to use a medicaiton to reduce nicotine dependency | Times the Subject Attempted to Reduce Nicotine Dependency | Record the number of times a subject attempted to use a medicaiton to reduce nicotine dependency |
| CMDUR |
|
|
|
| | 5 | FACAT | What is the category of the medication the subject used to attempt to reduce nicotine dependency? | Medication Category | Record the type of medicaiton the subject used to reduce nicotine dependency. |
Indicate if the subject experienced any medical conditions or events. If Yes, include the appropriate details where indicated on the CRF
| CMDUR |
|
| DAYS; MONTHS; YEARS |
| | 6 | CMCAT | What is the category of the medication the subject used to attempt to reduce nicotine dependency? | Medication Category | Record the type of medicaiton the subject used to reduce nicotine dependency. |
| CMCAT |
|
| NICOTINE REPLACEMENT THERAPY; DRUG USED IN REDUCING NICOTINE DEPENDENCE OTHER THAN NRTS; |
2
|
| | 7 | CMSCAT | What is the subcategory for the medication? | Medication Subcategory | Record the medication subcategory, if not pre-printed on the CRF. |
| CMSCAT |
|
|
| LAST ATTEMPTED USE WITH THIS MEDICATION |
3| 8 | CMTRT | What was the name of the medication the subject used to reduce nicotine dependency?
| Medication | Record only one medication per line. Provide the full trade or proprietary name of the medication; otherwise, record the generic name. |
Applicant-Defined CRF Completion Instructions | CMTRT | 4 | What was the duration of the medication used to reduce nicotine dependency for the last attempt? | Collected Duration | Provide the duration of the medication used. |
Record all relevant medical conditions or events, as defined in the protocol. Record only one medical condition or event per line. Ensure that the medical conditions or events listed on the Medical History page do not meet any of the exclusion criteria. | CMDUR | 5 | What was the duration unit of the medication used to reduce nicotine dependency for the last attempt? | Collected Duration Unit | Select the appropriate duration unit of the medication used. |
Record the start date of the medical event or condition using this format (DD-MON-YYYY). |