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.
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.))
SPDEVID Pre-populated | HTDDEV | ||
Record a description of the device event that occurred. | DETERM | _________________ | |
Record the date that the device event first occurred or was noted using this format (DD-MON-YYYY). | DESTDAT DESTDTC | _________________ | |
Record how often the incident occurred. | How frequently did the event occur? DEPATT | ||
Record what action was taken with the device as a result of the incident. | What action was taken with the study device? DEACNDEV | <DEACNDEV codelist> | |
Record the ID of the primary AE associated with the device event, if any. | DEAENO(n) ASSOCIATE WITH RELATED RECORD VIA RELREC | _________________ |
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