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Dan L. Duncan Cancer Center

Houston, Texas

BCM has 25 departments and more than 90 research and patient-care centers.
Dan L. Duncan Cancer Center
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Protocol Review and Monitoring Committee

All cancer-related clinical trials at Dan L. Duncan Cancer Center affiliated institutions are required to be reviewed by the Protocol Review and Monitoring Committee, also know as PRMC. Subject enrollment cannot begin until both PRMC and IRB approvals have been obtained for that protocol.

Structure

The system is comprised of the Protocol Review and Monitoring Committee, which is subdivided into three working groups, overseen by an Executive Committee (see Organizational Chart and Roster for membership):

  • Cell and Gene Therapy: All adult and pediatric protocols that meet one or more of these criteria must go to the CAGT WG:
    • involve the infusion of whole cell or vectors designed to modify the existing genetic structure of cells in subject,
    • target hemopoietic stem cell transplant patients,
    • are ancillary to cell or gene therapy studies, or
    • require RAC review.
  • Pediatric: All protocols that target patients less than or equal to the age of 21 and do not involve cell or gene therapy.
  • Adult: All protocols that target patients over the age of 21 and do not involve cell or gene therapy.

Function

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

Initial Protocol Review

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

The PRMC provides a mechanism to oversee the prioritization of competing protocols, ensuring the optimal use of DLDCC clinical resources for scientific purposes.

Continuing Protocol Review

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.

Scope

The PRMC reviews all cancer-related clinical trials at DLDCC institutions, including intervention studies (therapeutic or prevention) and screening, diagnostic, supportive care, epidemiological, ancillary, or correlative studies.

Process

Protocols should be submitted using the PRMC module in BRAIN, preferably prior to or concurrent with IRB submission. Instructions for using the PRMC module can be found here.

The working group (WG) will review the study, and the PI will be notified of the WG’s recommendation. Once the WG review is finished, the protocol will be presented to the Executive Committee for final approval. Subject enrollment cannot begin until this final PRMC approval is received from the Executive Committee.

Protocols must also be reviewed at least annually using the Continuing Review Coversheet (see coversheet for instructions). Please submit protocols for PRMC continuing review at the same time that you submit the annual IRB review.

Forms and Administrative Information

Coversheets for Protocol Submission (with instructions):

Reviewer Checklist (criteria for protocol review):

Meeting Schedules

PRMC Membership:

Standard Operating Procedures (SOPs)

PRMC Structure

Protocol Submission and Review Process

Clinical Trials Available

For a list of current cancer clinical trails available, please click here.

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