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Forms/Applications

Protocol Approval Process | Application Process | Forms

Prior to beginning research in the Clinical Research Center (CRC) (G-5035) or the Satellite CRC in the Saunders Research Building (1.302), researchers are required to submit an application for approval by the CRC. Depending upon which IRB (RSRB or WIRB) is used for study approval, there are two ways to submit a CRC application. Further instructions are provided below.

If you have any questions regarding this process, please contact the CTSI Administrative Assistant, Mary Little, at (585) 275-0653 or the CRC administrator, Kathleen Jensen, at (585) 275-0674. In addition, the rest of the CRC team is available for your inquiries regarding the operational protocol procedure. It is most helpful to address issues of concern prior to protocol submission.

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 changes to the CRC protocol submission/review process that took effect on January 1, 2013:

• IRB (RSRB or WIRB) approval will be required prior to CRC review.
• CRC review will consist 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 with IRB approval, as a scheduled review meeting is no longer required.
• If there are no questions or issues needing clarification during the review process, the protocol can be approved and a CRC protocol number will 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 protocol. 
• 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.
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Application Process

Depending upon which IRB (RSRB or WIRB) is used for study approval, there are two ways to submit a CRC application, including: 

1. CRC Protocol Submission Using the RSRB Online Submission System (ROSS).
   • When completing the RSRB application, select the check box requesting CRC services in section 62.1 of the application.  By checking this box, you will be provided with several questions to answer that are specific to the CRC. 
   • Once the RSRB approves the protocol, the CRC will be provided with access to the protocol submission in the ROSS system so that the CRC feasibility review can begin.
2. Electronic CRC Protocol Submission Application (to be used for studies reviewed by WIRB)
   • This CRC application form must be completed and submitted electronically to Mary Little, along with documentation of WIRB protocol approval, and the other required documents detailed in the table below.  Once these documents are received, the CRC feasibility review will begin. 

Please use the table below to determine the components that you must submit 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. 

CRC Involvement	Protocol	RSRB- or WIRB-Approved Consent Form	RSRB/WIRB Documentation of Approval	Investigator Brochure	Laboratory Manual or the Portion thereof that Relates to the Tests Conducted on the CRC	Measures / Assessments to be Conducted in the CRC	Cost Estimate Provided by the CRC
Nursing	yes	yes	yes	yes	yes	yes	yes
Nutrition Services	yes	yes	yes	yes	no	no	yes
Blood draw and processing (blood drawn on the CRC)	yes	yes	yes	no	yes	no	yes
Blood processing (blood draws not conducted on the CRC)	yes	yes	yes	no	yes	no	yes
Vital signs only	yes	yes	yes	no	no	no	yes
DEXA	yes	yes	yes	yes	no	no	yes
Space Only	yes	yes	yes	no	no	no	yes

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Forms

• CRC Protocol Submission Using the RSRB Online Submission System (ROSS)
• CRC Protocol Submission Application
• CRC Amendment Submission Form
• Application Information and General Instructions. There are several steps to starting a study on the CRC. This file outlines the steps that will help to ensure a well-planned study and a smooth initiation.
• Patient Care Orders-1 page and Patient Care Orders-2 pages. Once completed and signed appropriately, these templates can be used for Patient Care Orders. Any questions regarding this form should be directed to Research Nurse, Ann Miller at 275-2907.
• 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 protocol and informed consent.

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NIH Funding Acknowledgement ** Important ** All publications resulting from the utilization of CTSI resources are required to credit the CTSI grant by including the NIH FUNDING ACKNOWLEDGEMENT and must comply with the NIH Public Access Policy.