Clinical Research Shared Service

Director: Ed Sausville, M.D., Ph.D.

Clinical Research Protocol Office:
Interim Program Director:
Anita Moore, M.S., R.N., C.C.R.P.

Clinical research is an essential part of the mission of the University of Maryland Greenebaum Cancer Center (UMGCC). The mission of the Clinical Research Shared Service is to enhance the quality and facilitate the conduct of this research. The Clinical Research Shared Service participates in the development, activation, conduct and monitoring of clinical trials involving people with cancer at the UMGCC. The activities of the facility include:

  • Supports the scientific review of proposed research projects through the Clinical Research Committee (CRC)
  • Submission of approved projects to the Institutional Review Board (IRB) of the University of Maryland School of Medicine
  • Patient registration and data management
  • Preparation for third party audits, and all institutional and federal regulatory reporting
  • Monitoring of accrual to clinical trials
  • Supports the Data and Safety Monitoring Committee
  • Correspondence and reporting to the IRB
  • Supports the spot auditing of investigator-initiated research for data safety and good clinical research practices
  • Supports the Response Verification Committee to verify radiographic response

The Clinical Research Shared Service maintains a strong relationship with the IRB. By written agreement, the IRB will not review any trial that involves cancer patients unless it has been previously approved by the Clinical Research Committee (CRC) of the Cancer Center, and signed off by the Cancer Center Director. The IRB receives all correspondence from the chair of the CRC to individual principal investigators regarding reviewed protocols, and all reports and audit results of the Data and Safety Monitoring Committee.

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