Apply for CRC Support

Prior to beginning research in the Clinical Research Center (SRB 1.302) or Clinical Research Infusion Center (G-8169), researchers are required to submit an application for approval by the CRC. It is most helpful to address issues of concern prior to protocol submission. Questions about the application process or use of CRC services should be addressed to the following CRC personnel:

• Application Process: Karen Grabowski at karen_grabowski@urmc.rochester.edu 
• Nursing and DXA: Ann Miller at (585) 275-2907
• Nutrition Research: Nellie Wixom at (585) 275-4761 
• Coordinator Services: JoAnne VanBuskirk at (585) 275-4729

Protocol Approval Process

The CRC must approve a protocol prior to conducting research procedures on study subjects on the CRC or using CRC resources.

Please note the following information about the CRC protocol submission/review process:

• IRB (RSRB, single IRB, or central IRB) approval is required prior to CRC review.
• CRC review consists of a feasibility review for the requested use of CRC services or resources. The CRC is committed to prompt review of the protocol for feasibility.
• The review process starts upon receipt of the CRC application, IRB approval, and all required study documents.  All protocol materials need to be submitted at the same time.
• If there are no questions or issues needing clarification during the review process, the protocol can be approved and a CRC protocol number can be provided by the fifth business day after CRC receipt of the protocol.
• If the PI responds promptly to any questions or items of clarification arising from the review, it is estimated that the turnaround time for the feasibility review would be a total of two weeks from CRC receipt of the complete protocol submission package.
• The CRC strongly encourages study teams to work with the CRC staff prior to protocol submission to work out potential issues and reduce time to approval.

New Protocol Submissions

Protocols reviewed by the RSRB:

1. When filling out the protocol application in the Click IRB system, indicate that the study will use the resources of the CRC.
2. After RSRB approval has been received, complete the online application.

Protocols reviewed by an IRB external to the University of Rochester

After IRB approval indicating that the University of Rochester has been approved as a site for the research has been received, complete the online application.

Once the required documents are received, the CRC feasibility review will begin.

The table below details the components required for CRC protocol review. The required components are based upon the involvement of the CRC in the study. Incomplete submissions may result in delay of review.

Adding Use of CRC Resources or Services to a Study that has Already Received IRB Approval

Complete the online application. If the study was reviewed by an IRB external to the University of Rochester, the IRB approval document must indicate that the University of Rochester has been approved as a site for the research.

Protocol Amendments

When a protocol amendment impacts the CRC, a CRC Amendment Submission Form and supporting documentation need to be submitted to UR CTSI for CRC review. It is the responsibility of the study team to communicate protocol changes that impact the CRC.

Regardless of whether or not an amendment directly impacts the CRC, if the protocol or consent form is revised, a revised copy of the protocol or consent form needs to be forwarded to UR CTSI.

Fees

View the current fee schedule.

Cost Estimates

It is highly recommended that investigators obtain a CRC cost estimate as budgets are developed for grants and industry-funded protocols. The cost estimate request form must be submitted to CTSI@urmc.rochester.edu.  Please note that when studies using the CRC are submitted through IORA, a budget review is conducted to ensure that CRC costs are appropriately included. If a cost estimate has not been obtained before submission in IORA, there could be a delay in approving the study while a cost estimate is developed, and the updated budget is reviewed.

To request a cost estimate, please submit a CRC Cost Estimate Request Form to UR CTSI, along with the protocol or portion of the grant detailing the research study.

Forms

• CRC Amendment Submission Form
• CRC Cost Estimate Request Form
• Application Information and General Instructions. There are several steps to starting a study on the CRC. This document outlines the steps that will help to ensure a well-planned study and a smooth initiation.
• Preparing-for-a-CRC-In-service-Form
• CRC-Subject-Visit-Checklist-for-Coordinators
• Patient Care Orders - 1 open text section, Patient Care Orders - 2 open text sections, Patient Care Orders - 3 open text sections
• Patient Care Orders - 4 open text sections. Once completed and signed appropriately, these templates can be used for Patient Care Orders. Any questions regarding this form should be directed to CRC Nurse Manager, Ann Miller at (585) 275-2907.
• Study Visit Orders (to be used for studies that are minimal risk and have no medications ordered)
• Suggested Wording for CRC Procedures for Protocols/Consents. This document details research procedures commonly used on the CRC and specific descriptive wording, which can be used in the protocol and informed consent.