Protocol Review and Monitoring Committee (PRMC)
The Protocol Review and Monitoring Committee is charged with overseeing the scientific integrity of clinical cancer trials at the Markey Cancer Center. The PRMC reviews studies for scientific significance, priority and feasibility. Clinical trials will be considered by the PRMC if they are Phase I, II, or Phase III NCI cooperative group trials, industry-sponsored or institutional investigator-initiated clinical trials focusing on cancer prevention, cancer control or treatment that has been approved by the appropriate CCART. The PRMC ensures that the study design fulfills study objectives and helps principal investigators of investigator-initiated trials optimize the scientific value of their studies.
The PRMC has the authority to approve protocols for IRB submission, assign risk levels and monitoring schedules, and approve amendments to open protocols. Protocols approved by the PRMC will be reviewed by the PRMC throughout the lifetime of the study to determine whether a study continues to have scientific merit and progress is being made through accruals.
The PRMC also recommends amendments to, or termination of, a protocol. Such reasons include the development of a therapy that is superior to that proposed in the protocol, a change in the standard of care that is no longer reflected in the protocol, poor accrual, or other scientific or administrative reasons.
Study sponsors may contact the PRMC coordinator regarding the execution of Confidentiality Disclosure Agreements (CDAs) and the completion of site feasibility questionnaires at UKMCCPRMC@uky.edu.
Investigators who are interested in initiating a clinical trial should contact the PRMC Coordinator at UKMCCPRMC@uky.edu.
OnCore ePRMS Instructions
The ePRMS in OnCore is a paperless committee management system. ePRMS stands for Electronic Protocol Review and Monitoring System, and is designed to assist the workflow of the Protocol Review and Monitoring Committee (PRMC).
The ePRMS will be used by investigators, PRMC reviewers and CCART representatives to perform various functions of the PRMC as outlined below:
- Performing CCART reviews and signoffs
- Submitting studies
- Responding to PRMC Queries
- Viewing PRMC decisions
- Reviewing submissions
- Submitting PRMC review documentation
To access the ePRMS:
1) Log in to OnCore
- Visit: https://trials.mc.uky.edu/login
- Enter your LinkBlue ID and Password to log in
2) Choose ePRMS from the menu bar
Training materials for the ePRMS are available via SharePoint from within OnCore. To access the training documents:
- Log into OnCore using your LinkBlue ID and password
- Click on the Help icon in the upper right-hand corner
- Select “MCC-CRO OnCore Documentation” from the pull-down menu (If asked to authenticate, re-enter your LinkBlue ID and password)
The training documents are located in the ePRMS Training Documents section.
Training Document Title Role Description
“UKY ePRMS CCART Reviewer” CCART representatives Describes the process for performing sign-off searches and CCART sign-offs.
“UKY ePRMS SUBMITTER” Investigators Describes the process for study submission/withdrawal , responding to PRMC Queries & viewing PRMC decisions
“UKY ePRMS Reviewer PRMC Reviewers Describes the process for reviewing a submission through the ePRMS console (includes reviewer assignment notifications and review document uploads)
For assistance with submitting a protocol, doing a review or performing a CCART sign-off, contact April Bramel at 257-8213 or by email at email@example.com. Please note, that you will no longer be asked to fill out a “New Protocol Submission Form” when submitting a study for review. Instead, you will enter this information into OnCore via the ePRMS.