This is an example of a study were a heated stick and the associate device were used. The sponsor collected device events for the device and the actual heated stick as a single entity. 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.
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Team needs to decide : The level of modelling devices. We can model the single device with no components and collect AE related to the single device ( electronic cigarette ) . or we can model the components of the device ( a mouthpiece or drip tip, a cartridge (tank), a heating element or atomizer, which is sometimes accompanied by a clearomizer, and a battery.)) |
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| Order | CDASHIG Variable | Question Text | Prompt | Data Type | CRF Completion Instructions | SDTMIG Target | SDTM Variable Mapping | Controlled Terminology Codelist Name | CRF Implementation Notes | Permissible Values | Pre-populated Value | Query Display | List Style | Hidden |
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| 1 | SPDEVID | What device experienced the event? | Device Experienced Event | text | Indicate the device that was involved in the incident. | SPDEVID |
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| .HTDDEV | HEATED STICK DEVICE |
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| | 2 | DESPID | What is the device event identifier? | Device Event Identifier | text |
| DESPID | Sequential number usually populated by the system for use in associated the event with other CRFs, e.g,. AE |
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| Y | | 6 | DETERM | Describe the device event. | Device Event | text | Record a description of the device event that occurred. | DETERM |
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| | 7 | DESTDAT | 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). | DESTDTC |
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| | 10 | DEPATT | How frequently did the event occur? | Event Frequency | text | Record how often the incident occurred. | DEPATT |
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| Single Event; Intermittent; Continuous |
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| | 11 | DEACNDEV | What action was taken with or to the study device? | Action Taken With Device | text | Record what action was taken with the device as a result of the incident. | DEACNDEV |
| (DEACNDEV) | No change; Device modified/adjusted; Device replaced; Removed temporarily; Removed
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| | 12 | DEAENO(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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| Rows 1-4: | Show the 3 characteristics chosen to create the device identifier SPDEVID for a CGM. The DEVTYPE is required for all devices in DI; the manufacturer, model, together identify the device to the degree of granularity required in the study.
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Rows 5-8: | Show the same 3
characteristics used to create a device identifier (SPDEVID) for a second CGM. |
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| Row | STUDYID | DOMAIN | SPDEVID | DISEQ | DIPARMCD | DIPARM | DIVAL |
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| 1 | TOB07 | DI | 01-ABCHTDDEV | 1 | DEVTYPE | Device TypeMouthpiece | Heatstick System Holder and Charger | | 2 | TOB07 | DI | 01-ABCHTDDEV | 2 | MANUF | Manufacturer | Reliable Devices | | 3 | TOB07 | DI | 01-ABCHTDDEV | 3 | MODEL | Model Number | | | 5 | TOB07 | DI | 02-ABC | 1 | DEVTYPE | Device Type | Cartridge | | 6 | TOB07 | DI | 02-ABC | 2 | MANUF | Manufacturer | ManF A Device | | 7 | TOB07 | DI | 02-ABC | 3 | MODEL | Model Number | 900 Tob |
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| Row 1: | Shows a malfunction of an MRI calibration affecting 1 subject. In this case the individual MRI unit is not under study (e.g., when the MRI is used to obtain study measurements), and the sponsor decided to use the site number in SPDEVID. |
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| Row 2: | Shows a malfunction of the device under study where all subjects for the day were affected. If this single record is sufficient detail for the sponsor’s requirements, then no further records would be added; if there were a need to associate the malfunction with each subject (e.g., it led to several ral AEs), then a record could be added for each affected subject. USUBJID is null because this device malfunction was not specific to one subject. | | Row 3: | Shows a malfunction for a specific device under study and the associated subject. |
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Row | STUDYID | DOMAIN | USUBJID | SPDEVID | DESEQ | DETERM | DEDECODDECAT | DESEVDEDTC | DESTDTC | 1 | ABC-123TB005 | DE | 20222029 | Site 22HTDDEV | 1 | First calibration failed | Calibration failed | Calibration Failure | Minor | Broken Heater | Heater Malfunction | Minor2010-01-01 | 2009-12-28 | 2 | ABC-456TB005 | DE | 1059 | HTDDEV15033 | 1 | Data Loss | Data failure | Data Storage Failure | Won’t charge | Battery Malfunction | Major | 2009-01-062009-01-05 | 3 | ABC-789TB005 | DE | 2222 | 3067 | HTDDEV334-XRS-09 | 1 | Alignment Failure | Calibration failed | Calibration Failure | Major | Battery Malfunction | Battery Malfunction | Major2009-01-05 | 2009-01-05 |
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