Clinical Research Management Office

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

Clinical Research Management Office:
Program Director:
Theresa Cummings

Clinical research is an essential part of the mission of the University of Maryland Greenebaum Comprehensive Cancer Center (UMGCCC). The mission of the Clinical Research Management Office is to enhance the quality and facilitate the conduct of this research. The office participates in the development, activation, conduct and monitoring of clinical trials involving people with cancer at the UMGCCC. 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 Management Office 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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