CRF | Case Report Form Completion Instructions |
|---|
CDASH Name SDTMIG Target Variable | SDTM Target Mapping | Controlled Terminology Code List | Tabulation Target | Mapping Instructions | Controlled Terminology CodeList Name | Permissible Values | Pre-Populated Value |
|---|
| 1 | What was the |
medication | medically recognized product name? | Medication |
| Text | CMTRTC | CMTRT |
CMCAT | NICOTINE REPLACEMENT THERAPY: IN REDUCING OTHER THAN NRTS | | 2 |
| Pre-Specified Intervention |
| Text | CMPRESP |
CMSCAT | LAST ATTEMPTED USE WITH THIS MEDICATION| CMPRESP |
|
|
| Y | | 3 | Did the subject previously use |
medications | medically recognized products to reduce nicotine dependency? | Any |
Medications | Medically Rrecognized Products Taken For Nicotine Dependency | Indicate if the subject had used any medically |
acceptable | recognized products to attempt to |
reduce nicotine | reduce nicotine dependency | Text | CMOCCUR |
CMTRT| CMOCCUR |
| (NY) | No;Yes;Not Done |
| | 4 | How many times did the subject attempt to use use |
a medication | 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 |
a medication | medically recognized products to reduce nicotine dependency | Text | FAORRES | FAORRES |
CMDUR| 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 |
|---|
What is the category of the medication the subject used to attempt to reduce nicotine dependency? | Medication Category | Record the type of medication the subject used to reduce nicotine dependency. | FACAT | CMDUR | DAYS; MONTHS; YEARS |
|---|
| 6 | What is the category of the medication/product the subject used to attempt to reduce nicotine dependency? |
Medication Category | Record the type of medication the subject used to reduce nicotine dependency. | CMCAT | CMCAT |
|
| NICOTINE REPLACEMENT THERAPY |
; DRUG USED IN REDUCING NICOTINE DEPENDENCE OTHER THAN NRTS; subcategory for the medication?Medication Subcategory | Record the medication | medication/product subcategory, if not pre-printed on the CRF. | Subcategory | Applicant Defined | Text | CMSCAT | CMSCAT |
|
| LAST ATTEMPTED USE WITH THIS MEDICATION |
| | 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. | Text | CMTRT | CMTRT |
|
|
|
| | 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. | Text | CMCDUR | CMDUR |
|
|
|
| | 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. |
| Text | CMCDURU | CMDUR |
| (UNIT) | DAYS; MONTHS; YEARS |
|
| 
