Keeping All Institutional Review Board/Office for Research Protections (IRB/ORP) Correspondence!

These steps will help you start and maintain your IRB/ORP correspondence file throughout the course of your study.

1. Put your IRB application and all supporting materials you submitted for approval in a designated binder or electronic file. Supporting materials include scripts, recruitment brochures/posters/flyers, all survey/questionnaire instruments, letters of support, safety letters, etc.

2. Keep your IRB file updated:

• Remember to include updated IRB applications, emails from the IRB/ORP requesting additional information, your responses to requests for additional information and the research study's grant proposal (if applicable).
• Always keep the final, approved versions of instruments, recruitment materials, etc. on file, too.
• As communications (such as modification requests and approvals, Continuing Progress Reports [CPRs], etc.) are exchanged between you and the IRB/ORP add them to the binder or electronic file.

3. Check all emails received from the ORP/IRB for ATTACHMENTS - especially approval emails.

• Newly dated consent forms are sent via attachment after they are approved.
• Immediately print out the updated consent forms and use only the updated and approved ones to enroll new participants.

4. Using a log sheet may be useful to keep a chronological record of when you receive requests, when you submit documents, when you receive approvals.

Go to

• Avoiding the Consent Form Problem Area!
• Keeping Research Study Information Secure!
• Enrolling Participants - The Numbers Are Important!
• Communicating Is Key!
• Continuing Reviews. . .and a Final Note
• ORP Investigator Manual