Protocol Submission Information
Prior to beginning research on G-5035, 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 inquiries regarding the 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 at 275-5295 for details concerning submission deadline and committee meeting dates.
CRC Advisory Committee - 2009 Schedule |
||
Due Date: Protocol Submission to CRC |
Review Date for the Monday CRC Advisory Committee Meeting |
|
| January 12th | January 26, 2009 | |
| February 9th | February 23, 2009 | |
| March 9th | March 23, 2009 | |
| April 13th | April 27, 2009 | |
| May 4th | May 18, 2009 | |
| June 8th | June 22, 2009 | |
| July 13th | July 27, 2009 | |
| August 10th | August 24, 2009 | |
| September 14th | September 28, 2009 | |
| October 12th | October 26, 2009 | |
| November 9th | November 23, 2009 | |
| December 7th | December 21, 2009 | |
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. If you are submitting a brand new RSRB application, please use the RSRB electronic submission system 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 several questions to you that are specific to the CRC. Required information is located in section 72 (Parts, 1, 2 and 3), which include 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.
Once the protocol is approved, 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 Protocol Submission Application below.
This is a two-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 and the RSRB or WIRB 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
- CRC Protocol Application Instructions
- CRC Amendment Submission Form
- Safety Monitoring Requirement Policy
- Safety Monitoring Waiver Request Application
- Safety Monitoring Waiver Request Policy
- 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, 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.


Email this page