This is an example of a study were the sponsor collected events associated with the operation of the electronic cigarette device.
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. TEDCODE DEDCODE was the Level 3 IMDRF term.
| Xformpusher |
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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 | SPTOBID | What was the tobacco product identifier? | Tobacco Product Identifier | text | Indicate the tobacco product that was involved in the incident. | SPTOBID |
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| VAPE-Z01 |
| radio |
| | 6 | PITERM | What was the event associated with this tobacco product? | Tobacco Product Event | text | Record a description of the event that occurred. | PITERM |
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| | 7 | PISTDAT | What was the start date when the event first occurred or was identified? | Start Date | text | Record the date that the event first occurred or was noted using this format (DD-MON-YYYY). | PISTDTC |
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| | 10 | PIEPATT | How frequently did the event occur? | Event Frequency | text | Record how often the event occurred. | PIPATT |
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| Single Event; Intermittent; Continuous |
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| radio |
| | 11 | PIACNDEV | What action was taken with the study device? | Action Taken With Device | text | Record what action was taken with the tobacco product as a result of the event. | PIACNDEV |
| (DEACNDEV) | No Change; Tobacco Product Replaced;
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| radio |
| | 12 | PIAENO(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 event, if any. | N/A | ASSOCIATE WITH RELATED RECORD VIA RELREC |
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| Dataset wrap |
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| Dataset2 |
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| Row | STUDYID | DOMAIN | SPTOBID | TOSEQ | TOTESTCD | TOTEST | TOCAT | TOORRES | TOORRESU | TOSTRESC | TOSTRESN | TOSTRESU |
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| 1 | TB005 | TO | VAPE-Z01 | | TBPRDCAT | Tobacco Product Category | PRODUCT IDENTIFIER | ENDS (VAPES) |
| ENDS (VAPES) |
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| | 2 | TB005 | TO | VAPE-Z01 | 2 | TBPRSCAT | Tobacco Product Subcategory | PRODUCT IDENTIFIER | Closed E-Cigarette |
| Closed E-Cigarette |
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| | 3 | TB005 | TO | VAPE-Z01 | 3 | MANUF | Manufacturer | PRODUCT IDENTIFIER | XX Vapes USA |
| XXX Vapes USA |
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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 was the Level 3 IMDRF term.
Example PI Variable Metadata
| Variable | Label | Type | Codelist |
|---|
| DEIMDRCD | IMDRF Code | text | IMDRFANNEXA |
| DEIMDRFL2 | IMDRF Level 2 | text | IMDRFANNEXA |
| DEIMDRFL1 | IMDRF Level 1 | text | IMDRFANNEXA |
Example External Dictionaries
| Dataset wrap |
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| Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | SPTOBID | PISEQ | PITERM | PIDECOD | PIMODIFY | PIEVACT | PISTDTC |
| PIIMDRCD | PIIMDRL2 | PIIMDRL1 |
|---|
1 | TB005 | PI | 2029 | 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 | PI | 1059 | 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 | PI | 3067 | 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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| Nsvmeta |
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| | Variable | Label | Type | Role | Origin |
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| PIIMDRCD | IMDR Code | Char | Non-standard Variable Qualifier of DEDECOD | Assigned | | PIIMDRL2 | IMDR Level 2 | Char | Non-standard Variable Qualifier of DEDECOD | Assigned | | PIIMDRL1 | IMDR Level 1 | Char | Non-standard Variable Qualifier of DEDECOD | Assigned |
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