Question:
If a study is closed, when do study related activities require IRB review and approval?
-Program Director, CRO
Response:
After IRB oversight has been closed out, sponsors or research sites may need to conduct after-study activities which may or may not require IRB approval. Once a study is closed with the IRB, some study related activities can occur without IRB approval, while some require IRB approval and the study to be re-opened.
What after-study activities require review and approval?
- Collection of new adverse event information or follow-up information from subject(s) for research purposes, for example, interviewing subjects or sending additional questionnaires or obtaining new feedback from use of investigational products.
- Collection of new data such as review of medical records when obtaining new data related the study.
- Formal distribution of treatment randomization assignment and/or unblinding information to subjects through written means (e.g., letter).
- Any study interventions.
What after-study activities do not require IRB review and approval?
- Review of study records if obtaining or verifying data that had already been collected prior to study conclusion unless the research is federally funded. If the research is federally funded the study would need to be re-opened until data analysis is complete.
- Informal distribution of treatment randomization assignment and/or unblinding/blinding information to subjects (e.g., phone call).
- Return of study results. This information can be shared in any format, including written.