Section 1 | Order | CDASH Variable Name | Question Text | Prompt | CRF Completion Instructions |
|---|
SDTMIG Target Variable | SDTM Target Mapping| Type | Collection Variable | Tabulation Target | Mapping Instuctions | Controlled Terminology Code List Name | Permissible Values | Pre-Populated Value |
|---|
| 1 | What is the |
category of the medication the subject used to attempt to reduce nicotine dependency? | object? |
|
| Text | FAOBJ | FAOBJ |
|
|
| TOBACCO | | 2 | What was the age of the subject when they started smoking? | Age Started Smoking | Record the Age Category when the subject started smoking | Text | AGESTSMK__FAORRES | FAORRES | FAORRES WHERE FATESTCD = "AGESTSMK" and FAOBJ = "TOBACCO" |
| 16-24 years; 25-34 years; 45–64 years; 65 years and older |
| | 3 | Did the subject have any tobacco cessation counseling? | Tobacco Cessation Counseling | Indicate whether the subject had previous tobacco cessation counseling | Text | TBCESSCO__FAORRES | FAORRES | FAORRES WHERE FATESTCD = "TBCESSCO" and FAOBJ = "TOBACCO" | (NY) | No;Yes |
| | 4 | What is the longest duration of previous abstinence from tobacco use? | Longest Duration of Abstinence | Record the longest duration of tobacco abstinence | Text | LDURABS__FAORRES | FAORRES | FAORRES WHERE FATESTCD = "LDURABS" and FAOBJ = "TOBACCO" |
| ≤7 days; 8–28 days;1–6 months; >6 months |
|
Section 2 | Order | Question Text | Prompt | CRF Completion Instructions | Type | Collection Variable | Tabulation Target | Mapping Instuctions | Controlled Terminology Code List Name | Permissible Values | Pre-Populated Value |
|---|
| 5 | What is the type of tobacco product used by the subject? | Substance Use Category | Record the type of tobacco product used. | Text | SUCAT | SUCAT |
|
| SMOKED TOBACCO PRODUCT; SMOKELESS TOBACCO PRODUCT (e.g., CHEWING TOBACCO, SNUFF, DIP, SNUS, or DISSOLVABLE TOBACCO PRODUCT) |
| | 6 | What was the brand name of the tobacco product?
| Product Name | Record the brand name of the tobacco product used. | Text | SUTRT | SUTRT |
|
|
|
| | 7 | Is this the subject's usual brand of tobacco product? | Substance Use Subcategory | Indicate if this is the subject's usual brand of tobacco product used | Text | SUSCAT | SUSCAT |
|
| USUAL BRAND; NOT USUAL BRAND |
| | 9 | What was the duration of use of the tobacco product ? | Duration | Provide the duration for the product used | Text | SUCDUR | SUDUR |
|
|
|
| | 9 | What was the unit of duration of use of the tobacco product? | Unit | Select the appropriate duration unit for the product used | Text | SUCDURU | SUDUR |
|
| DAYS; MONTHS; YEARS; |
| | 10 | Is the tobacco use ongoing? | Ongoing | Record the product used as ongoing if the subject has not stopped taking the product used at the time of data collection. The end date should be left blank. | Text | SUONGO | SUENRF; SUENRTPT | SUENRF or SUENRTPT | (NY) | No;Yes |
| | 11 | What was the end date? | End Date | Record the date the product used was stopped |
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 | 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). If the subject has not stopped taking the product used leave this field blank. | Date |
CMDUR | DAYS; MONTHS; YEARS | 
