Protocol Submission Information
Prior to beginning research on 4-3400, researchers are required to submit an application for approval by the CRC Advisory Committee. Depending on 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 CRC administrative secretary, Mary Little, at (585) 275-5295 or the CRC administrator, Kathleen Jensen, at (585) 275-6409. In addition, the rest of the CRC team is available for your inquires regarding operational protocol procedure. It is most helpful to address issues of concern prior to protocol submission.
Protocol submission deadline is usually the 2nd Monday of every month. The CRC Advisory Committee (GAC) meeting is held on the 4th Monday of every month. Should one of these dates fall close to a holiday, check with the CRC office at (585) 275-6409 for details on deadline submission and committee meeting dates.
CRC Advisory Committee (GAC) - 2007 Schedule |
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Due Date: Protocol Submission to CRC |
Review Date for the Monday GAC Meeting |
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| January 8 | January 22 | |
| February 12 | February 26 | |
| March 12 | March 26 | |
| April 9 | April 23 | |
| May 7 | May 21 | |
| June 11 | June 25 | |
| July 9 | July 23 | |
| August 13 | August 27 | |
| September 10 | September 24 | |
| October 8 | October 22 | |
| November 12 | November 26 | |
| December 3 | December 17 | |
Forms/Application Process
Protocol Approval
Depending on which IRB (RSRB or WIRB) is used for study approval, there are two ways to submit a CRC application.
1. For CRC protocol submissions using the RSRB approval process, please complete the RSRB application.
The RSRB application contains all the information required by the CRC for review. This application is available at https://rsrb01.urmc.rochester.edu and you must select the check box requesting CRC services in section 62.1 of the RSRB application. By checking this box, the application will forward you to several questions that are specific to the CRC. Required information is located in section 72 (Parts, 1, 2, and 3), which includes specific instructions to assist in answering the questions.
Once the RSRB application is completed and submitted by the Principal Investigator, the system will automatically notify the CRC that a protocol is waiting for review. You do not need to provide the CRC with any additional information.
Your CRC protocol will be reviewed at the next regularly scheduled CRC Advisory Committee (GAC) meeting. Once the protocol is approved by the GAC, the RSRB will be notified and their review process will begin.
2. For CRC protocol submissions using the WIRB approval process, please use the CRC application.
This is a two-part process:
Part 1: The CRC application form (located on the CRC website) must be completed and submitted to the CRC with a copy of the informed consent form (WIRB-approved or draft) and the protocol (as submitted to the WIRB).
Part 2: The protocol must be reviewed and approved by the CRC Advisory Committee (GAC) prior to conducting research procedures on study subjects on the CRC, or using CRC resources.
Click on the pertinent bullet below:
- CRC Protocol Submission Using the RSRB Website Application Approval Process
- CRC Protocol Submission Application Using the WIRB Approval Process
- CRC Protocol Application Instructions for WIRB Approval Process
- Conducting Research Studies on the Clinical Research Center - CRC Information Sheet. 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 Mark Cloninger at (585) 275-2907.
- 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.
- Protocol Deviation Form. Navigate to the CRC Research Subject Advocate section for more details on the use of this form.


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