FAQs

Q: What IRB documents should I keep in the Regulatory Binder?

Copies of all signed and dated IRB submissions and written correspondence between the study site and the IRB should be kept on file.

Q: How should these documents be filed?

The QI Program recommends filing documents in reverse chronological order. Only one copy of each correspondence is needed.

Q: Where can I get copies of missing IRB documentation?

Request a copy of any missing documents from your protocol administrator.