Please keep a full, complete copy of your approved protocol, including the approved versions of recruitment materials, consent documents, debriefing statements, instruments, etc. in your study binder.
A study binder is a tool to help you to present study documents in a well-‐organized, up-‐to-‐date, complete, convenient way. Documents should be organized and maintained in a systematic way so it can be easily be determined that the study is in compliance with regulations.
The approved version dates are on the approval letter provided to you by your OHRP manager.
You must have prior IRB approval before you implement changes. Follow the approved protocol and use the approved collateral materials until changes have been approved by the IRB.
Upon approval by the IRB of your modifications/amendment, you should incorporate the modified versions into your approved protocol in your study binder.
You will be asked to complete a renewal form (at least annually) and to provide copies of the currently approved protocol, including collateral materials, with renewal applications. The form asks for information including but not limited to enrollment numbers, adverse events, modifications, and complaints.
Providing incomplete or outdated materials may delay the renewal process.
OHRP does not have the authority to offer an investigator an extension or grace period for submission. If your protocol expires, you must begin the process over with a new application and supporting documents for the IRB review. You would end your recruitment, enrollment and data collection on your research study until you are approved by the IRB. Be safe and submit complete renewal applications early!
If you have questions about your approved versions or how to build and maintain your study binder, please contact the Research Integrity Office at (775) 327-2368.