All faculty who hold an IND or IDE for a particular study are considered the sponsor or sponsor-investigator of the study. If you are an IND/IDE sponsor-investigator, please refer to the DUHS policy “Responsibilities of an Investigator Who is Also a Sponsor” and the ORAQ page.
Additional reminders:
- You must upload the protocol that is submitted to FDA as part of your iRIS submission. The protocol submitted to FDA should match what is submitted on the IRB protocol application. All modifications/changes to the protocol should be submitted to both FDA and the IRB and the IRB protocol application should be updated accordingly.
- The DUHS IRB Policy “Significant Risk or Non-Significant Risk Device Determinations by the DUHS IRB” has been revised to include Sponsor/Investigator Responsibilities and information regarding when to reach out to ORAQ. .
- Recommendation: Study team members supporting a clinical study with an IND or IDE are encouraged to take the applicable ORAQ Sponsor and Investigator LMS training, which is required for all faculty who hold an IND or IDE. This training will provide information to all study team members on sponsor and investigator requirements for an IND or IDE as well as resources to ensure compliance with FDA regulations.
There are two separate training modules within the LMS that focus on the requirements for the specific regulatory application that the sponsor or sponsor-investigator holds. The training module entitled “Duke University Training Modules on IND Sponsor and Investigator Responsibilities” outlines the regulatory requirements for sponsors who hold an IND (for drugs and biologics). The training module entitled “Duke University Training Modules on IDE Sponsor and Investigator Responsibilities” outlines the regulatory requirements for sponsors who hold an IDE (for medical devices).