VCU Massey Cancer Center

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Clinical Trials Office

The Clinical Trials Office (CTO) provides support for investigators conducting clinical research at VCU Massey Cancer Center. CTO leadership and staff facilitate the development and conduct of institutional studies (including investigator-initiated trials (IITsJ), NCI studies (including National Clinlcal Trial Network [NCTN] trials), industry-sponsored studies, and consortia trials. This office coordinates closely with the Biostatistics Shared Resource, Protocol Review and Monitoring Committee (PRMC), Data and Safety Monitoring Committee (DSMC), Cancer Informatics Core and Administration.

The types of assistance and support that are provided to principal investigators conducting clinical research include the following:

  • Assisting in developing the protocol document and consent form for IITs
  • Coordinating activities required for study activation
  • Assessing study feasibility and providing support for completion of budgets and contracts
  • Facilitating scientific review by the PRMC
  • Providing regulatory affairs support (for examp,le IRB submission and communications)
  • Screening patients to determine protocol-specific eligibility
  • Coordinating testing, treatment and other protocol-specific interventions for patients enrolled in studies
  • Collaborating with investigators to perform adverse event assessment, recording and reporting
  • Entering patient data in appropriate databases
  • Coordinating sponsor communications (for example, amendments to update safety information, revise study requirements, etc)
  • Performing internal auditing and monitoring according to PRMC and Data Safety Monitoring Committee requirements; facilitating external audits and monitor visits
  • Maintaining study records
  • Providing clinical trial information and results as required (for example on the clinicaltrials.gov website)
  • Collaborating with the principal investigator and study biostatistician to oversee data capture and analysis for IITs providing high quality data for study publication

Our listing of clinical trials is located in OnCore