CRC Protocol Application Process
All requests for use of CRC services are reviewed for scientific merit and appropriateness resource utilization.
- New submissions and amendments will be handled as they are received on a rolling submission basis.
- Format: Submit electronically as MS Word document or pdf file to amy.Marra@uvmhealth.org
- Brief e-mail notification will be sent out following the review.
- Official memo with action and requirements, reviewers' comments, and cost analysis will be mailed to you within 2-3 days of the review.
- Contingencies attached to the approval of a protocol must be addressed in writing and approved by the CRC prior to scheduling the protocol meeting.
The CRC recognizes that research is a continuous process and that changes in the conduct of a study and/or changes to the consent document are necessary. However, no changes to an approved protocol should be implemented until the CRC Scientific Review Committee and the IRB has reviewed and approved the changes. This includes, but is not limited to,
- scientific changes, new research questions and or methods
- subject recruitment methods
- consent form changes
- treatment changes
- amendments to the sponsor’s master protocol
- as well as changes or additions in study sites, investigators, or key personnel
- changes in utilization and needs of the CRC resources.
Major modifications/amendments potentially affecting the risk/benefit ratio are reviewed through the full committee review process, minor modifications not affecting the risk to subjects may be reviewed through an expedited review process.
Materials Required for submission of an amendment to the CRC are as follows (as applicable):
- Copy of the Request for Modification/Amendment to Approved Protocol
- Revised CRC Resource Request Form
- Materials justifying changes
- Revised protocols, tracked changes and clean copy
- Revised consent or information sheets
- Revised recruitment materials
- Any revised documents provided to subjects (questionnaires/diaries/educational materials)
Prior to release of CRC approval of an amendment we must have a copy of the IRB approval for the amendment, for Cancer protocols we also require a copy of the PRMC approval.
Investigators have the responsibility to formally close a study with current IRB/CRC approval once it is completed or discontinued. Among other reasons for closing out a study, this informs the IRB and CRC on the conduct and outcomes of the study, including any risks or problems that may have arisen since the last study renewal and which may need to be disclosed to the study participants or others.
Do not close-out a study if any of the following six conditions apply. Such studies must remain active and continue to receive ongoing IRB review and approval.
- Enrollment ongoing
- Research-related interventions and/or follow-up ongoing
- Subject follow-up ongoing
- Biological specimens containing personally identifiable information are being maintained in a repository that has been approved as part of this study or upon which analysis or research is ongoing. If, however, specimens have been transferred to a separate repository that has ongoing IRB approval, the study may be closed
- Primary data analysis or manuscript preparation that involves the use or access to personally identifiable information ongoing.
- If there is an external study sponsor and the sponsor has not provided permission to close the study with the IRB.
You must close out a protocol utilizing a Request for Continuing Review form.
Phone: (802) 656-8990