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.
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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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The sponsor based on previous experinece
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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 | 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 |
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| | 2 | DESPID | What is the device event identifier? | Device Event Identifier | text |
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| Sponsor-defined |
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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 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 replaced;
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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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The associated SDTM datasets for the data collected above are provided below. The DI domain is used to identify the device. Only one device was of interest in the study.
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| Row | STUDYID | DOMAIN | SPDEVID | DISEQ | DIPARMCD | DIPARM | DIVAL |
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| 1 | TOB07 | DI | HTDDEV | 1 | DEVTYPE | Device Type | Heatstick System Holder and Charger | | 2 | TOB07 | DI | HTDDEV | 2 | MANUF | Manufacturer | Reliable Devices | | 3 | TOB07 | DI | HTDDEV | 3 | MODEL | Model Number | |
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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: | 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. | | Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | SPDEVID | DESEQ | DETERM | DEDECOD | DESEVDEVACT | DESTDTC | 1 | TB005 | DE | 2029 | HTDDEV | 1 | Broken Heater | Heater Malfunction | MinorDevice Replaced | 2009-12-28 | 2 | TB005 | DE | 1059 | HTDDEV | 1 | Won’t charge | Battery Malfunction | MajorBattery Replaced | 2009-01-05 | 3 | TB005 | DE | 3067 | HTDDEV | 1 | Battery Malfunction | Battery Malfunction | MajorBattery Replaced | 2009-01-05 |
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