Clinical Research Support

Protocol Data Monitoring Committee

The Protocol Data Monitoring Committee (PDMC) meets on the same schedule as the IRB to review the yearly progress of clinical research. Before submission to the IRB, the study must undergo continuing Protocol Review and Monitoring System (PRMS) review by the Protocol Data Monitoring Committee. The PDMC reviews and compares information that is provided by the Data Management Office, the PI, and Clinical Research Support to ensure that all reported data is accurate and complete.

PDMC review is based on the following criteria:

  • Patient Accrual Data
  • Annual Update Information
  • Toxicity
  • Changing status of existing protocols

Studies PDMC Reviews:

  • New protocols that have been reviewed and approved by the Scientific Review Committee (SRC) and Institutional Review Board (IRB)
  • Ongoing interventional studies (Primary and Secondary Therapy Protocols)

Studies PDMC Does NOT Review:

  • Community intervention protocols
  • Non-intervention protocols
  • Protocols with appropriate external review
  • Standard treatment protocols

Note: Additional review of these protocols may be provided if requested by the chairperson from PDMC or SRC

Studies are referred to the Scientific Review Committee (SRC) under the following conditions:

  • If accrual is too high or too low
  • If there are many adverse events
  • If there are protocol exceptions

Under these conditions, the SRC will either request that the PI revise the protocol or close the study.

Renewals not received by the Clinical Research Support (CRS) on time are unable to undergo appropriate PRMS review, and are therefore ineligible for submission to the IRB. Turning in late reports will result in the suspension of accrual for your study. Accrual will be suspended until the renewal is submitted to the CRS and the appropriate PRMS review can take place.

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