There are This example CRF has 2 sections in this example. The questions : Questions in the first section focus on whether any smoking cessation product is has been used, and the questions in the second section collect each individual product used. . For each smoking cessation product. If multiple other products are used, create a row for each other product. In order to save space, some of the permissible values are only shown in the metadata specifications.
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title | CDASH CM Metadata Specifications |
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Section 1 Metadataspec |
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CRF Case Report Form Completion Instructions |
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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 |
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1 | What is the category for the medication? | Concomitant Medication Category | CMCAT
| Text | CMCAT |
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| SMOKING CESSATION PRODUCT | 2 | Were any smoking cessation products taken? | Any Smoking Cessation Products Taken | Indicate if the subject took any smoking cessation products If yes, include the appropriate details where indicated on the CRF. | CMOCCURCMPRESPYes; No |
Section 2 For each smoking cessation product. If multiple other products are used, create a row for each other product. Metadataspec |
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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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3 | What was the smoking cessation product used? | Smoking Cessation Product | Select the smoking cessation product. | Text | CMTRT | CMTRT | CMTRT; CMPRESP; If CMTRT="OTHER" Then CMTRT and CMPRESP are NULL. |
| NICOTINE PATCH; NICOTINE GUM; NICOTINE LOZENGE; NICOTINE INHALER; VARENICLINE; BUPROPION; OTHER |
| 4 | Was the Did the subject previously use the selected medication/product for smoking cessation | product used | Smoking Cessation Product Used | For each product indicate product was used.subject had used the selected smoking cessation product | Text | CMOCCUR | CMOCCUR | CMOCCUR No |
| 5 | What was the name of the other smoking cessation product used? | Smoking Cessation Product Other | Indicate the Other type of product previously used. | Text | CMTRTOTCMTRTO | CMTRT |
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| 6 | Was the smoking cessation product discontinued due to | a an adverse experience? | Reason Smoking Cessation Product Discontinued | Indicate if the product was discontinued due to | a CMCRSDISText | CMRSDISC | CMRSDISC | If Yes then CMRSDISC = "ADVERSE | Experience; No: |
| 7 | What was the last date the product was used? | Last Date Smoking Cessation Product Used | Indicate the last date the product was used. If the product was used with the last 14 days, a complete date must be recorded. Otherwise, partial dates can be recorded. | Date | CMENDAT | CMENDTC |
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