CDASH Variable Name CRF | Case Report Form Completion Instructions | Type |
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SDTMIG Target SDTM Target Mapping | Controlled Terminology Code List | Tabulation Target | Mapping Instructions | Controlled Terminology CodeList Name | Permissible Values | Pre-Populated Value |
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| 1 | What |
is 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. | 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. | CMSCAT | LAST ATTEMPTED USE WITH THIS MEDICATION | | the disposition? | Disposition Category | If collected on the CRF, the applicant provides instructions to ensure the data is entered as intended. | Text | DSCAT | DSCAT |
| (DSCAT) |
| DISPOSITION EVENT | | 2 | What is the trial epoch for this disposition event? | Epoch | Select the study epoch for which disposition is being recorded. | Text | EPOCH | EPOCH |
| (EPOCH) | SCREENING; PRODUCT EXPOSURE; FOLLOW-UP; |
| | 3 | What was the completion/discontinuation date? | Completion/Discontinuation Date | Record the date that the subject completed the study or study period using this format. If the subject did not complete the study or study period, record the date that the subject discontinued. | Date | DSSTDAT | DSSTDTC |
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| | 4 | What was the subject's status? | Status | Document the subject's status for the study or study period. If the subject discontinued prematurely, record the primary reason for discontinuation. | Text | DSDECOD | DSDECOD |
| (TNCOMPLT | COMPLETED; ADVERSE EXPERIENCE; DEATH; LOST TO FOLLOW-UP; PROTOCOL DEVIATION; SCREEN FAILURE; SITE TERMINATED BY APPLICANT; STUDY TERMINATED BY APPLICANT; WITHDRAWAL BY SUBJECT; OTHER. |
| | 5 | What was the verbatim reason for the subject status? | Specify | If Adverse Experiences, Death, Protocol Deviation or Other is selected from the Status list, provide the verbatim reason. | Text | DSTERM | DSTERM |
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| | 6 | Will the subject continue into the next epoch? | Continue | Record if the subject will be continuing to the next study period of this study. | Text |
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| NOT SUBMITTED | (NY) | No; Yes |
| | 7 | What is the next epoch the subject will continue to enter? | Next Epoch | Record the planned subsequent study epoch in which the subject intends to participate. | Text |
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| NOT SUBMITTED | (EPOCH) | PRODUCT EXPOSURE; FOLLOW-UP. |
3 | 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). | CMDUR | DAYS; MONTHS; YEARS | 
