Clinical Trials Office

About the Clinical Trials Office

Massey's Clinical Trials Office (CTO) supports investigators conducting clinical, translational and population science research at Massey. Through the services listed below, CTO leadership and staff promote the conduct of high-quality human subjects research and facilitate the development of numerous cancer-related studies including the following:

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CTO support services

The services listed below are available to principal investigators conducting clinical research at MCC:

Clinical operations provide disease working group support, study initiation oversight, patient screening, eligibility confirmation and enrollment, protocol activity management, study data collection, clinical research sample processing and preparation, and collaboration with all patient care teams to ensure study parameters are met.

Regulatory services provide new trial feasibility review management, study activation coordination, FDA IND and IDE application preparation and submission, and overall management of regulatory activities through the lifecycle of a study.

The research finance team assists with both pre- and post-award activities including coverage analysis, OnCore study calendar creation, study budgets preparation and negotiation, contract review and execution in coordination with the VCU Department of Sponsored Programs, clinical research charge review, investigators and ancillary service payment, and monthly account reconciliation. This team also supports the development of budgets and/or cost estimates for IIT concepts or Letters of Intent.

This team provides expertise in new concept development, protocol writing, electronic case report form creation and overall study management of both single- and multi-site IITs through close out and manuscript development.

QAC activities include independent monitoring and auditing of Massey IITs per the risk assignment level outlined in Massey's NCI-approved Data and Safety Monitoring Plan.

The Affiliate Network team provides operational support, training and education, progress reporting and compliance monitoring for sites participating under Massey’s MU-NCORP.

This unit ensures all clinical research reporting requirements are met such as and NCI Clinical Trials Reporting Program.

Clinical research committees and resources

Protocol Review and Monitoring Committee (PRMC) 

The PRMC conducts independent, peer review of the scientific merit and progress of all clinical cancer research studies conducted at Massey.

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Data and Safety Monitoring Committee (DSMC)

The DSMC is directly responsible for the data and safety monitoring of approved and activated Massey investigator-initiated, interventional studies.

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Clinical and Translational Research Laboratory

The Clinical and Translational Research Laboratory (CTRL) supports the design, development and implementation of correlative studies for IITs.

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Clinical Trials Concept Review

Massey supports the advancement of translational clinical trial concepts based on laboratory discoveries of Massey research members.

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