Protocol Review and Monitoring Committee
What is the PRMC?
The Protocol Review and Monitoring Committee (PRMC) is a joint multidisciplinary committee between UF Health Cancer Center (UFHCC), UF Health Cancer Center-Orlando Health (UFHCC-OH) and UF Health Proton Therapy Institute (UFPTI). The committee’s mission is to enhance the quality of cancer research conducted at the University of Florida Health Cancer Center, UF Health Cancer Center-Orlando Health, and the UF Health Proton Therapy Institute by providing scientific oversight for national or cooperative group research protocols, investigator-initiated research protocols and sponsor-initiated research protocols.
The committee will ensure effective allocation of UFHCC, UFHCC-OH and UFPTI resources to support research protocols by evaluating each protocol for:
- Scientific merit
- Risk/benefit ratio
- Biostatical soundness
- Resource utilization
- Adequate and feasible progress towards achievement of study endpoints
What authority and responsibility does the PRMC have?
The PRMC reviews all studies of cancer or specific to patients with cancer that require the consent of participants, and are conducted by faculty at any of three participating institutions supported by the PRMC. The PRMC reviews studies for scientific design, priority and feasibility. Clinical trials will be considered by the PRMC if they are considered Phase I, II or III, NCI cooperative group trials, industry sponsored or institutional investigator-initiated clinical trials focusing on cancer prevention, cancer control or cancer treatment. Studies under review by the PRMC must have been approved by the appropriate disease site group. The PRMC ensures that the study design fulfills study objectives and helps principal investigators (PIs) of investigator-initiated clinical trials optimize the scientific value of their studies.
The PRMC has the authority of approving protocols prior to Internal Review Board (IRB) approval and assigning a PRMC review schedule for approved protocols. Protocols approved by the PRMC will be reviewed while open to accrual to determine if a study demonstrates continued scientific merit and meets satisfactory progress towards achievement of study endpoints.
During the initial submission and annual reviews, the PRMC may recommend amendments to, or termination of, a protocol. Such reasons include the development of therapy which is superior to that proposed in the protocol or a change in the standard of care which is no longer reflected in the protocol, poor accrual, or other scientific or administrative reasons. These recommendations should be inclusive of recommendations and oversight from the Data Safety Monitoring Board (DSMB), where appropriate.
When does the PRMC meet?
The PRMC meets twice per month on the first and third Mondays at 12:30 p.m. The meetings are held at the following locations for the three participating sites:
- Gainesville: Communicore Building (C3-17)
- Orlando: Telemedicine Conference Room 4th Floor UF Health Cancer Center
- Jacksonville: Marco Conference Room
How do I submit a study or protocol to the PRMC for review?
The PRMC utilizes OnCore®, a clinical trials management system to document the submission and electronic routing and workflow tracking system. In order to submit documents into the ePRMS module of OnCore®, you must have an OnCore® user account.
If you need an OnCore® account in order to submit a protocol to the PRMC, please contact our user access team at email@example.com. If you are an employee of UF Health, you can complete the OnCore® user account request form here.
How do I know if my study needs to be submitted through the PRMC?
All studies of cancer or specific to patients with cancer that require the consent of participants and are conducted by UFHCC, UFHCC-OH, or UFPTI faculty or on the UFHCC partner institutions’ campus must be reviewed by the PRMC.
Who can I speak to regarding the PRMC or for more information?
For information related to the PRMC, please contact Brian Sevier, associate director at firstname.lastname@example.org or 352.273.8280; or David Ortiz, PRMC and DSMB coordinator at email@example.com or 321.841.7031
This core is available to individuals who are Cancer Center members. In order to become a member of the UF Health Cancer Center, please visit the Membership Policy and Application site. For further questions about membership with the UFHCC, please contact Wendy Malorzo or call 352.273.8294.