Question: If a study is closed, when do study related activities require IRB review and approval? 

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. The table below addresses which after-study activities require IRB review and approval, and which ones do not. 

After-Study Activities Requiring Review	After-Study Activities Not Requiring Review
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.	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.
Collection of new data such as review of medical records when obtaining new data related the study.	Informal distribution of treatment randomization assignment and/or unblinding/blinding information to subjects (e.g., phone call).
Formal distribution of treatment randomization assignment and/or unblinding information to subjects through written means (e.g., letter).	Return of study results. This information can be shared in any format, including written.
Any study interventions.