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. TEDCODE was the Level 3 IMDRF term.
SPTOBID Pre-populated | VAPE-Z01 | ||
Record a description of the device event that occurred. | TETERM | _________________ | |
Record the date that the device event first occurred or was noted using this format (DD-MON-YYYY). | TESTDAT TESTDTC | _________________ | |
Record how often the incident occurred. | How frequently did the event occur? TEPATT | ||
Record what action was taken with the device as a result of the incident. | What action was taken with the study device? TEACNDEV | <DEACNDEV codelist> | |
Record the ID of the primary AE associated with the device event, if any. | TEAENO(n) ASSOCIATE WITH RELATED RECORD VIA RELREC | _________________ |
The associated SDTM datasets for the data collected above are provided below. The Tobacco Product Identifier (TO) domain is a study reference dataset that provides a mechanism for uniquely identifying a tobacco product. Only one product was of interest in the study.