Protocol Development / Review

In preparing for submission to the Institutional Review Board (IRB), faculty members consult with the CRO staff for protocol development and to review their clinical research studies for operational feasibility.

On this page:

Why do we need protocol development and review?

Many IRB approvals are delayed because of poorly prepared or incomplete submission documentation. A review may help you identify areas of the protocol that require clarification or additional information that can facilitate IRB approval. 

To help speed up the approval timelines, the IRB might ask you to work with the CRO, particularly if there are many areas to be reviewed. This allows for more effective use of the IRB members in reviewing those studies that are truly ready for IRB review and approval.

Questions on protocol review?

Contact Kimberly Brunton, RN, MSN

(716) 888-4840

How do we complete a protocol review?

All Investigator-initiated protocols submitted to the IRB must be on the template HRP-503-Template Protocol.

All sponsored protocols, when submitted to the IRB, must include both the sponsor protocol and a completed supplement document, called HRP-508-Template Site Supplement to Sponsor Protocol.

You can find both these documents in the Click portal, in the IRB Library section under the “Templates” tab. Submitting your protocol information to the CRO on one of these two templates is a first step in the review.

How much time does it take to complete a protocol review?

It will take three—five business days for a review of the protocol and to receive feedback, depending on the number of studies being reviewed at any one time. The CRO will provide protocol feedback through a tracked changes/comment type format. 

If requested, we will meet with you one-on-one to go over comments or suggested edits.