This form collects events and malfunctions associated with the operation of the tobacco product device.
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| title | CDASH EM Metadata Specifications |
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| 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 | Any Tobacco Product Events | Any Tobacco Product Events | Indicate if the subject experienced any medical conditions or events. If Yes, include the appropriate details where indicated on the CRF. | Text | EMYN | EMYN | N/A | (NY) | Yes;No |
| | 2 | Tobacco Product Identifier | Tobacco Product Identifier | Indicate the product that was associated with the event. | Text | SPTOBID | SPTOBID |
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| VAPE-Z01 | | 3 | What was the event or malfunction associated with this device? | Tobacco Product Device Event | Record a description of the toboacco product device event or malfunction that occurred. | Text | EMTERM | EMTERM |
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| | 4 | What was the start date when the event or malfunction first occurred or was identified? | Start Date | Record the date that the event or malfunction first occurred or was noted using this format (DD-MON-YYYY). | Date | EMSTDAT | EMSTDTC |
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| | 5 | What was the pattern of the event of malfunction? | Pattern of Tobacco Product Device Event | Record the pattern of the the event or malfunction that occurred. | Text | EMPATT | EMPATT |
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| Single Event; Intermittent; Continuous |
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| What action was taken with the device? | Action Taken With Device | Record what action was taken with the device as a result of the event. | Text | EMACNDEV | EMACNDEV |
| (DEACNDEV) | No Action Taken; Device Replaced; Battery Replaced
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| What was the identifier for the primary adverse event(s) associated with or related to this device event? | Related Adverse Event ID | Record the ID of the primary AE associated with event, if any. | Text | EMAENO(n) | N/A | ASSOCIATE WITH RELATED RECORD VIA RELREC |
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