Cancer Clinical Trials Review Committees

Protocol Review and Monitoring Committee

All cancer-related protocols at Cedars-Sinai cancer are required to be reviewed by the Protocol Review and Monitoring Committee, also known as PRMC. PRMC is a multidisciplinary committee charged with the scientific review of clinical studies. Subject enrollment cannot begin until both PRMC and IRB approvals have been obtained and a study activation notice received for the specific protocol.

The objectives of Protocol Review and Monitoring Committee (PRMC) are to:

  • Assure through peer review scientific quality, feasibility, timeliness and ethics,
  • Foster development of the cancer institute clinical research protocols,
  • Assign priorities in the use of the instiute's resources to support clinical research, and
  • Monitor the progress of ongoing research studies

The PRMC has the authority to:

  • Approve or disapprove the submission of protocols to the Institutional Review Board (IRB)
  • Require modifications in any aspect of a study protocol prior to IRB approval
  • Require supplemental supporting background information before completing review of a protocol

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.

Cancer Clinical Trials Review Committees
Cancer Clinical Trials Review Committees
Cancer Clinical Trials Review Committees
Cancer Clinical Trials Review Committees
Cancer Clinical Trials Review Committees
Cancer Clinical Trials Review Committees

Full Committee

During the Full Committee Review process, reviewers utilize a review form to document key elements of the study; answer questions with respect to study rationale, scientific merit, quality and adequacy of the design, and eligibility criteria; and confirm an appropriate data and safety monitoring plan, data analysis plan, expected accrual rates, completion feasibility, and risk profile of the study. The PRMC assigns protocol risk to institutional trials (low, moderate, and high) based on the risk assignment criteria in the Center’s Data and Safety Monitoring Plan. The PRMC also reviews the documentation provided by the Disease Research Group to ensure there are no competing studies and the study was highly valued.

Expedited Review

Expedited Reviews are conducted by the PRMC Chair and/or Vice Chair and are generally limited to those studies identified as eligible for Expedited Review. For studies meeting the criteria, the PRMC Chair and/or the Vice Chair reviews all submission materials and gives a rapid expedited review, assuring that conflicts with current studies do not exist, resources appear to be in place to implement and complete the study, and an appropriate data and safety monitoring plan is in place. If no substantive issues are identified during the review, the PRMC Coordinator will then generate an approval letter which is then routed via email through OnCore to the PI. Expedited reviews are completed within seven business days of receipt. A summary report of all studies that received expedited review since the last PRMC Full Committee is included in the agenda and noted in the minutes for each PRMC meeting.

Exempt

The following studies are exempt from PRMC review: single-use IND, retrospective studies, registries and biorepositories and questionnaires that do not test interventions.

Data Safety Monitoring Committee (DSMC)

Cedars-Sinai places the highest priority on ensuring the safety of human subjects participating in clinical trials and the conduct of integrity-based research producing high quality data. The Data and Safety Monitoring Committee is a dedicated multidisciplinary committee of healthcare providers and statisticians who are reviewing the data and safety of studies initiated and coordinated by Cedars-Sinai Cancer Institute investigators.

The objectives of Data and Safety Monitoring Committee (DSMC) is to:

  • Ensure safety of study participants 
  • Evaluate and monitor data collection associated with the trial 
  • Evaluate interim analysis of studies as appropriate
  • Oversee the quality of protocol conduct
  • Release the final dataset associated with the trial

The DSMC has the authority to make the following final determination on all DSMC reviews for studies with accrual:

  • Approve for continued accrual
  • Approve for continued accrual with recommendations
  • Suspend accrual until further review
  • Suspend accrual and recommend for accrual closure

 DSMC is an established system in compliance with Federal/State regulatory and Good Clinical Practice requirements.

Cancer Clinical Trials Review Committees
Cancer Clinical Trials Review Committees
Cancer Clinical Trials Review Committees
Cancer Clinical Trials Review Committees
Cancer Clinical Trials Review Committees
Disease Research Groups

Multidisciplinary teams, collaborating to advance cancer clinical trials and research initiatives for 15 key disease areas.

Have Questions or Need Help?

If you have any questions or wish to learn about the Cancer Clinical Trial Office, please call us.

8700 Beverly Blvd.
Los Angeles, CA 90048