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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.
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| title | CDASH CM Metadata Specifications |
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| Metadataspec |
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| CDASH Variable | CRF | Case Report Form Completion Instructions | Type |
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SDTMIG Target SDTMIG Target Mapping | Controlled Terminology Code List | Tabulation Target | Mapping Instructions | Controlled Terminology CodeList Name | Permissible Values | Pre-Populated Value |
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Query Display | List Style | HiddenCMTRT medication | medically recognized product name? | Medication |
| Text | CMTRTC | CMTRT |
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| DRUG USED IN NICOTINE DEPENDENCE | | 2 |
CMPRESP |
| Pre-Specified Intervention |
| Text | CMPRESP |
YCMOCCUR | | 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 | CMOCCUR |
| (NY) | No;Yes; |
NoFAORRES | | How many times did the subject attempt to use |
a medicaiton | 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 |
a medicaiton | medically recognized products to reduce nicotine dependency | Text | FAORRES | FAORRES | FAORRES where FAOBJ ="MEDICATION USED IN NICOTINE DEPENDENCE" and FATEST= Total Number " |
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FACAT | What iwas the category? |
| Category |
| Text | FACAT | FACAT |
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| 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 |
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What was the medication name? | Medication | Text | CMTRT | CMCAT | NICOTINE REPLACEMENT THERAPY: DRUG USED IN REDUCING NICOTINE DEPENDENCE OTHER THAN NRTS 2 | Pre-Specified Intervention | Text | CMPRESP | CMSCAT | LAST ATTEMPTED USE WITH THIS MEDICATION | 3 | 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 | Text | CMOCCUR | CMTRT | 45 | How many times did the subject attempt to use a medication to reduce nicotine dependency. | Times the Subject Attempted to Reduce Nicotine Dependency | Record the number of times a subject attempted to use a medication to reduce nicotine dependency | Text | FAORRES | CMDUR | | 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. | FACAT | CMDUR | DAYS; MONTHS; YEARS | 6 | 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. | CMCAT | CMCAT | CMCAT | | CMTRT | CMCAT |
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| NICOTINE REPLACEMENT THERAPY: NOT A NRT |
NICOTINE REPLACEMENT THERAPY; DRUG USED IN REDUCING NICOTINE DEPENDENCE OTHER THAN NRTS; the subcategory for ?Medication Subcategory | Record the medication | /product subcategory, if not pre-printed on the CRF. |
CMSCAT| Subcategory | Applicant Defined | Text | CMSCAT | CMSCAT |
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| 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. |
CMTRT| Text | CMTRT | CMTRT |
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| | 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 |
CMCDUR |
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| | 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. |
CMCDURU
| (UNIT) | DAYS; MONTHS; YEARS |
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