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Forms/Applications

Prior to beginning research in the Clinical Research Center (CRC) (G-5035), researchers are required to submit an application for approval by the CRC. Instructions are detailed below.  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 – Mary Little at (585) 275-0653

Nursing and DXA – Ann Miller at (585) 275-2907

Nutrition Research – Nellie Wixom at (585) 275-3918 

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.
    • 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.

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Application Process

New Protocol Submissions

Requests for CRC resources or services are submitted via 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 and the CRC will receive access to your study documents in the ROSS system.

Depending upon which IRB (RSRB, single IRB, or central IRB) is used for study approval, the next step in the process varies.

  1. Protocols reviewed by the RSRB - Once the RSRB approves the protocol, the CRC will be provided with access to the protocol submission and study documents in the ROSS system so that the CRC feasibility review can begin.
  1. Protocols reviewed by a single IRB or central IRB that indicated at initial submission in the ROSS system that the CRC would be used – Once IRB approval is received, the study team must electronically submit to CTSI documentation of IRB approval for the University of Rochester study site, the IRB-approved consent form(s), and any study documents that were revised or created during the course of protocol review.  The CRC will have access to any study documents unchanged since initial submission in the ROSS system.  Once the required documents are received, the CRC feasibility review will begin. 
  1. Protocols reviewed by a single IRB or central IRB that did not indicate at initial submission in the ROSS system that the CRC would be used – Electronically submit the CRC Protocol Submission Application located in the Forms section below, IRB approval, IRB-approved consent form(s), departmental scientific review of the study, and the required study documents detailed in the table below to  CTSI.  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.

CRC Involvement

Protocol

IRB-Approved Consent Form

IRB Documentation of Approval

Manual or the Portion thereof that Relates to the Tests Conducted on the CRC

Measures/ Assessments to be Conducted in the CRC

Nursing

yes

yes

yes

yes

yes

Nutrition Services

yes

yes

yes

no

no

Blood draw and processing (blood drawn on the CRC)

yes

yes

yes

yes

no

Blood processing (blood draws not conducted on the CRC)

yes

yes

yes

yes

no

Vital signs only

yes

yes

yes

no

no

DXA

yes

yes

yes

no

no

CRC Use (no services required)

yes

yes

yes

no

no

 

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Adding Use of CRC Resources or Services to an Ongoing Study

  1. RSRB-approved Studies - An amendment needs to be submitted to the RSRB to add CRC resources or services.  This is done by updating the RSRB application to indicate in section 62.1 that CRC services are requested, and answering the questions that are specific to the CRC.  Once the study team forwards to CTSI documentation of the amendment approval, the CRC review process will begin. 
  2. Single IRB- or Central IRB-Approved Studies – Electronically submit the CRC Protocol Submission Application, IRB approval, IRB-approved consent form(s), departmental scientific review of the study, and the required study documents detailed in the table above to CTSI.

 

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Protocol Amendments

  • When a protocol amendment impacts the CRC, a CRC Amendment Submission Form needs to be submitted to 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 for a single IRB- or central IRB-approved study is revised, a copy of the protocol or consent form needs to be forwarded to CTSI

Fees

  • Fees for use of the Clinical Research Center are substantially subsidized, up to 80% of costs.  The current fee schedule is available here .
  • The Clinical Research Center provides cost estimates to assist in budget development for grants or industry-funded protocols. To request a cost estimate, please submit to CTSI the CRC Cost Estimate Request Form below and the protocol or portion of the grant detailing the research study.   

Forms

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