This is an example of a study were the sponsor collected Device events associated with the Heatstick System Holder and Charger. The sponsor did not collect device events for the heatstick used in the System Holder and Charger. The International Medical Device Regulators Forum (IMDRF) document “IMDRF Terminologies for Categorized Adverse Event Reporting (AER): Terms, Terminology Structure and Codes was used by the sponsor. Annex A ( 2022) provide the medical problem codes. The name and version of the dictionary used to map terms must be provided in a Define.XML ExternalCodeList element. DEDCODE TEDCODE was the Level 3 IMDRF term.
Example DE Variable Metadata
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Example External Dictionaries
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| Order | CDASHIG Variable | Question Text | Prompt | Data Type | CRF Completion Instructions | SDTMIG Target | SDTM Variable Mapping | Controlled Terminology Codelist Name | Permissible Values | Pre-populated Value | Query Display | List Style | Hidden |
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| 1 | SPDEVIDSPTOBID | What device experienced the event?was the tobacco product identifier? | Tobacco Product Identifier Device Experienced Event | text | Indicate the device that tobacco product that was involved in the incident. | SPDEVIDSPTOBID | HTDDEV | radio | 2 | DESPID | What is the device event identifier? | Device Event Identifier | text | DESPID | Sponsor-defined |
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| VAPE-Z01 |
| radioY |
| | 6 | DETERMTETERM | Describe the device event. | Device Event | text | Record a description of the device event that occurred. | DETERMTETERM |
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| | 7 | DESTDATTESTDAT | What was the start date when the event first occurred or was identified? | Start Date | text | Record the date that the device event first occurred or was noted using this format (DD-MON-YYYY). | DESTDTCTESTDTC |
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| | 10 | DEPATTTEPATT | How frequently did the event occur? | Event Frequency | text | Record how often the incident occurred. | DEPATTTEPATT |
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| Single Event; Intermittent; Continuous |
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| | 11 | DEACNDEVTEACNDEV | What action was taken with the study device? | Action Taken With Device | text | Record what action was taken with the device as a result of the incident. | DEACNDEVTEACNDEV |
| (DEACNDEV) | No change; Device replaced;
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| | 12 | DEAENOTEAENO(n) | What was the identifier for the primary adverse event(s) associated with or related to this device event? | Related Adverse Event ID | text | Record the ID of the primary AE associated with the device event, if any. | N/A | ASSOCIATE WITH RELATED RECORD VIA RELREC |
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The associated SDTM datasets for the data collected above are provided below. The DI domain is used to identify the deviceThe Tobacco Product Identifier (TO) domain is a study reference dataset that provides a mechanism for uniquely identifying a tobacco product. Only one device product was of interest in the study.
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| Rows 1-3: | Show the records for a tobacco product given SPTOBID of VAPE-Z27. |
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| SPDEVID | DISEQ | DIPARMCD | DIPARM | DIVAL | SPTOBID | TOSEQ | TOTESTCD | TOTEST | TOCAT | TOORRES | TOORRESU | TOSTRESC | TOSTRESN | TOSTRESU |
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TOB07DIHTDDEVDEVTYPE | Device Type | Heatstick System Holder and Charger | TBPRDCAT | Tobacco Product Category | PRODUCT IDENTIFIER | ENDS (VAPES) |
| ENDS (VAPES) |
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TOB07DIHTDDEVMANUF | Manufacturer | Reliable Devices | TBPRSCAT | Tobacco Product Subcategory | PRODUCT IDENTIFIER | Closed E-Cigarette |
| Closed E-Cigarette |
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TOB07DIHTDDEVMODEL | Model Number | 700XYZ| MANUF | Manufacturer | PRODUCT IDENTIFIER | XX Vapes USA |
| XXX Vapes USA |
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| Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | SPDEVIDSPTOBID | DESEQTESEQ | DETERMTETERM | DEDECODTEDECOD | DEMODIFYTEMODIFY | DEVACTTEVACT | DESTDTCTESTDTC |
| DEIMDRCDTEIMDRCD | DEIMDRFL2TEIMDRL2 | DEIMDRFL1TEIMDRL1 |
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1 | TB005 | DETE | 2029HTDDEV | VAPE-Z01 | 1 | Broken Heater | Mechanical Problem | Mechanical Problem | Device Replaced | 2009-12-28 |
| A05 | Mechanical Problem | Mechanical Problem |
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2 | TB005 | DETE | 1059HTDDEV | VAPE-Z01 | 1 | Won’t charge | | Charging Problem | Battery Replaced | 2009-01-05 |
| A0706 | Charging Problem | Electrical /Electronic Property Problem |
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3 | TB005 | DETE | 3067HTDDEV | VAPE-Z01 | 1 | Battery Malfunction | Battery Problem | Battery Problem | Battery Replaced | 2009-01-05 |
| A0705 | Battery Problem | Electrical /Electronic Property Problem |
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| | Variable | Label | Type | Role | Origin |
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| DEIMDRCD | IMDRF Code | Char | Non-standard Variable Qualifier of DEDECOD | Assigned | | DEIMDRFL2DEIMDRL2 | IMDRF Level 2 | Char | Non-standard Variable Qualifier of DEDECOD | Assigned | | DEIMDRFL1DEIMDRL1 | IMDRF Level 1 | Char | Non-standard Variable Qualifier of DEDECOD | Assigned |
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