IDE Reports: Investigator Annual Progress Reports and Final Reports

The IDE regulations do not specify the content of the annual progress or final reports. Therefore, the contents of these reports may largely be dictated by the sponsor. With respect to reports to the IRB, the IRB itself may specify what information it wishes to be included in these reports. Because FDA does require the information listed below, it is suggested that, at a minimum, the annual progress and final reports to the sponsor and the IRB include the following items:

1. IDE number
2. name
3. Indications for use
4. Brief summary of study progress in relation to investigational plan
5. Number of subjects enrolled
6. Number of devices received, used, and, in the final report, the final disposition of unused devices
7. Brief summary of results and, in the final report, conclusions
8. Summary of anticipated and unanticipated adverse device effects
9. Description of any deviations from investigational plan
10. Reprints of any articles published by the investigator in relation to the study