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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.

CRDM Flow Chart JPG 

The PRMC has the authority to approve protocols for IRB submission, assigning risk levels and monitoring schedules and approving 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 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 initiate this process via the ePRMS in OnCore.

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:

CCART representatives

  • Performing CCART reviews and signoffs

Investigators

  • Submitting studies
  • Responding to PRMC Queries
  • Viewing PRMC decisions

PRMC Reviewers

  • Reviewing submissions
  • Submitting PRMC review documentation

To access the ePRMS:

1) Log into OnCore

2) Choose ePRMS from the menu bar

ePRMS Training

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)

If you need assistance with an OnCore account, contact Bryan Baseheart at 323-3604 or by email at bjbase@uky.edu.

For assistance with submitting a protocol, doing a review or performing a CCART sign-off, contact Elizabeth Rush at 257-8213 or by email at elizabeth.rush2@uky.edu. 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.

Page last updated: 6/4/2014 3:55:56 PM