CDASH Variable Name CRF | Case Report Form Completion Instructions | Type |
|---|
SDTMIG Target SDTM Target Mapping | Controlled Terminology Code List | Tabulation Target | Mapping Instructions | Controlled Terminology CodeList Name | Permissible Values | Pre-Populated Value |
|---|
| 1 | What |
is the category of the medication the subject used to attempt | was the medically recognized product name? | Medication |
| Text | CMTRTC | CMTRT |
|
|
| DRUG USED IN NICOTINE DEPENDENCE | | 2 |
| Pre-Specified Intervention |
| Text | CMPRESP | CMPRESP |
|
|
| Y | | 3 | Did the subject previously use medically recognized products 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. | | Any Medically Rrecognized Products Taken For Nicotine Dependency | Indicate if the subject had used any medically recognized products to attempt to reduce nicotine dependency | Text | CMOCCUR | CMOCCUR |
| (NY) | No;Yes;Not Done |
| | 4 | How many times did the subject attempt to use use medically recognized products to reduce nicotine dependency | Times the Subject Attempted to Reduce Nicotine Dependency | Record the number of times a subject attempted to use medically recognized products to reduce nicotine dependency | Text | FAORRES | FAORRES | FAORRES where FAOBJ ="MEDICATION USED IN NICOTINE DEPENDENCE" and FATEST= Total Number " |
|
|
| | 5 |
| Category |
| Text | FACAT | FACAT |
|
|
| ATTEMPTS TO REDUCE NICOTINE DEPENDENCE |
| Order | Question Text | Prompt | Case Report Form Completion Instructions | Type | Collection Variable | Tabulation Target | Mapping Instructions | Controlled Terminology CodeList Name | Permissible Values | Pre-Populated Value |
|---|
| 6 | What is the category of the medication/product the subject used to attempt to reduce nicotine dependency? | Medication |
| Text | CMTRT | CMCAT |
|
| NICOTINE REPLACEMENT THERAPY: NOT A NRT |
| | 7 | What is the medication/product |
CMCAT | NICOTINE REPLACEMENT THERAPY; DRUG USED IN REDUCING NICOTINE DEPENDENCE OTHER THAN NRTS; 2 | What is the subcategory for the medication? | Medication Subcategory | Record the medication | subcategory, if not pre-printed on the CRF. | Subcategory | Applicant Defined | Text | CMSCAT | CMSCAT |
|
| LAST ATTEMPTED USE WITH THIS MEDICATION |
3
| | 8 | What was the name of the medication/product the subject used to reduce nicotine dependency?
| Medication | Record only one medication/product per line. Provide the full trade or proprietary name of the medication/product; otherwise, record the generic name. |
Applicant-Defined CRF Completion Instructions4
|
|
|
| | 9 | What was the duration of the medication/product used to reduce nicotine dependency for the last attempt? |
| Collected Duration | Provide the duration of the medication/product 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.5
|
|
|
| | 10 | What was the duration unit of the medication/product used to reduce nicotine dependency for the last attempt? |
| Collected Duration Unit | Select the appropriate duration unit of the medication/product used. |
Record the start date of the medical event or condition using this format (DD-MON-YYYY). | CMDUR | 
