Protocol Submission Information

Prior to beginning research on 4-3400, researchers are required to submit a application for approval by the CRC Advisory Committee. Depending on which IRB (RSRB or WIRB) is used for study approval, there are two ways for submitting a CRC application. Further instructions are given below.

If you have any questions regarding this process please contact the CRC administrative secretary, Mary Little at 275-5295 or the CRC administrator, Kathleen Jensen at 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 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 275-6409 for details on deadline submission and committee meeting dates.

Forms/Application Process

PROTOCOL APPROVAL: 

There are two ways for submitting a CRC application.

1. If you are submitting a brand new RSRB application, please use the RSRB Web bridge application and follow the directions listed below.

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 meeting.  CRC submission deadlines are located on the CRC website - www.urmc.rochester.edu/medicine/gcrc/.

Once the protocol is approved by the CRC Advisory Committee, the RSRB will be notified and their review process will begin.

2.  For CRC protocol submissions that are already approved by RSRB, or a new submission to WIRB, please use the electronic CRC application.

This is a 2-part process:

Part 1:        The CRC application form (located on the CRC website) must be completed and submitted electronically to Mary Little at Mary_Little@urmc.rochester.edu with the informed consent and protocol, plus any other required documents requested in the application.

Part 2:        The protocol must be reviewed and approved by the CRC Advisory Committee 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 . 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 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 protocool and informed consent.
•  Protocol Deviation Form. Navigate to the CRC Research Subject Advocate section for more details on the use of this form.