Cancer Center Protocol Review and Monitoring Committee

All interventional cancer-related clinical trials at Dan L Duncan Comprehensive Cancer Center affiliated institutions are required to be reviewed by the Protocol Review and Monitoring Committee, also known as PRMC. This review is required for NCI-designated cancer centers, and it focuses on the protocol's scientific merit and prioritization. Subject enrollment cannot begin until both PRMC and IRB approvals have been obtained for that protocol.

The purpose of the PRMC is to provide internal, centralized oversight of cancer clinical research at all DLDCCC institutions and facilities.

The review process is designed to ensure the highest quality of research according to following criteria:

• High scientific merit, including rationale, study design, and adequacy of biostatistical input
• Clinical feasibility
• Reasonable accrual for completion within a practical time frame
• Benefit to our patient population
• Protocol prioritization, to optimize the use of DLDCCC resources
• Ongoing (continuing) review for accrual, changes in scientific merit, and changes in prioritization since last PRMC review

The PRMC reviews all interventional cancer-related clinical trials within the institutions that comprise the Dan L Duncan Comprehensive Cancer Center. All interventional clinical trials whose primary aim is cancer related, or whose primary target population is cancer patients, must receive approval from the PRMC before patient enrollment

First Stage of Initial Review:  Program or Disease Working Group Review

All protocols must first be reviewed by the relevant Program or Disease Working Group, which will discuss the study’s priority, scientific merit, rationale, study design, prioritization, feasibility for completion within a reasonable time frame, and potential duplication of studies already in progress.  The Program/DWG recommendations will be recorded on the Scientific Review Score Sheet; the PI will include the completed Score Sheet with the protocol submission to the PRMC.

Second Stage of Initial Review: PRMC

After review by the Program/DWG, the PI will submit the protocol (with completed Score Sheet) to the PRMC for review. 

Protocols that have already had adequate external peer review (such as NCI NCTN studies) will undergo Expedited PRMC review. 

Other protocols (such as IITs without external peer review or Industry studies) will undergo Full PRMC review, and will be discussed at a convened PRMC meeting. 

Studies which have been approved for enrollment will be reviewed annually, or more frequently at the discretion of the PRMC. Studies will be reviewed for accrual, changes in scientific merit, and changes in prioritization since last PRMC review.

Instructions for continuing review submission in BRAIN.

Older studies (before PRMC BRAIN module) may use the coversheet linked below.

• Initial Review: All new submissions should use the PRMC BRAIN module: (instructions)
• Continuing Review in BRAIN - (instructions)
• Continuing Review Coversheet (for studies opened before the BRAIN module)
• Amendment Review Coversheet (for studies opened before the BRAIN module)

This checklist is a reference of the criteria that will be considered while the protocol goes through PRMC review.

• PRMC Reviewer Checklist 

View the current PRMC Meeting Schedule and submission deadlines.