What steps should I take with the IRB if I receive a grant or contract termination notice for a study involving participants?
Once a Termination notice is received:
- Submit a protocol violation/incident reporting form and select "loss of resources" (see Post Approval Reporting Form, even if you will be filing an appeal.
- Report the change in study status, and, if applicable, describe the measures you are taking to ensure a safe tapering or termination of study procedures for participants.
- Include the agency termination notice and a projected timeline for closing the study.
Note:
- The IRB will advise if a study modification will be necessary.
- Once study enrollment, visits, record review, and data analysis are completed, promptly submit a Study Closeout report.
- Do not submit a study closeout report if an appeal is currently pending. Ensure that the study does not expire by submitting Continuing Review Reports according to schedule.
If you need assistance completing the reporting form, please submit an Ask Andy request, and an analyst will contact you.