Research: Shared Services

Clinical Research Shared Service

Clinical Research
Shared Service

Revised Clinical Investigator Handbook coming soon

Clinical Research Protocol Office:
Program Director: Maureen Klein, R.N., B.S.N., O.C.N.

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.

This page was last updated on: August 11, 2009.