| 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 |
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| 1 | What is was the category of the medication the subject used to attempt to reduce nicotine dependency? | Medication Category | the disposition? | Disposition Category | If collected on the CRF, the applicant provides instructions to ensure the data is entered as intendedRecord 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. | DSCAT | CMCAT |
| (DSCAT) |
| DISPOSITION EVENTNICOTINE REPLACEMENT THERAPY; DRUG USED IN REDUCING NICOTINE DEPENDENCE OTHER THAN NRTS; |
| 2 | What is the subcategory for the medicationtrial epoch for this disposition event? | Medication SubcategoryEpoch | Record the medication subcategory, if not pre-printed on the CRF. | CMSCAT | Select the study epoch for which disposition is being recorded. |
| EPOCH |
| (EPOCH) | SCREENING; PRODUCT EXPOSURE; FOLLOW-UP;LAST ATTEMPTED USE WITH THIS MEDICATION |
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| 3 | What was the name of the medication the subject used to reduce nicotine dependency?
| Medication | 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 discontinuedRecord 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 | CMTRTDSSTDTC |
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| 4 | duration of the medication used to reduce nicotine dependency for the last attempt? | Collected Duration | | Status | Document the subject's status for the study or study period. If the subject discontinued prematurely, record the primary reason for discontinuation.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. | DSDECOD |
| (NCOMPLT) | COMPLETED; ADVERSE EXPERIENCE; DEATH; LOST TO FOLLOW-UP; NON-COMPLIANCE WITH STUDY PRODUCT; PHYSICIAN DECISION; PREGNANCY; PROTOCOL DEVIATION; SITE TERMINATED BY APPLICANT; STUDY TERMINATED BY APPLICANT; WITHDRAWAL BY SUBJECT; OTHERCMDUR |
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| 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 | 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. |
| 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. |
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| NOT SUBMITTED | (NY) | No; Yes |
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| 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. |
| N/A | NOT SUBMITTED | (EPOCH) | PRODUCT EXPOSURE; FOLLOW-UP;DAYS; MONTHS; YEARS |
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