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. 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 | Type |
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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. |
CMOCCUR CMPRESP; 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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CRF | Case Report Form Completion Instructions | Type |
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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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| 3 | What |
is the category for the medication?Concomitant Medication Category | CMCAT | CMCAT | SMOKING CESSATION PRODUCT | 4 | 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. | CMOCCUR | CMOCCUR | CMOCCUR; CMPRESP | (NY) | Yes; No | 5 | 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 |
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| | 4 | Did the subject previously use the selected medication/product for smoking cessation? |
Was the 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 No7
| | 5 | What was the name of the other smoking cessation product used? | Smoking Cessation Product Other | Indicate the Other type of product previously used. |
CMTRTOT8
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| | 6 | Was the smoking cessation product discontinued due to an adverse experience? | Reason Smoking Cessation Product Discontinued | Indicate if the product was discontinued due to an Adverse Experience | Text |
CMCRSDIS| CMRSDISC | CMRSDISC | If Yes then CMRSDISC = "ADVERSE EXPERIENCE" | (NY) | No:Yes |
; No9
| | 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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