Services and rates
The Clinical Research Shared Resource (CRSR) Core assists clinical investigators through the following services:
- Regulatory compliance
Regulatory coordinators serve as liaisons with institutional and external regulatory authorities, including the Protocol Review and Monitoring Committee (PRMC) at VCU Massey Cancer Center, Institutional Review Board (IRB), Institutional Biosafety Committee (IBC), Cancer Therapy Evaluation Program (CTEP), U.S. Food and Drug Administration (FDA), etc.
- Subject recruitment
Research nurses and clinical research associates (CRAs) assist in case findings for research participants, informed consent discussion and evaluation for protocol eligibility.
- Protocol compliance
Research nurses and CRAs support clinical investigators through coordination with the various components of the VCU Health System (VCUHS), including clinics, imaging services, investigational pharmacy and pathology services involved in the clinical management of patients. They also assist in participant/patient education and treatment management.
- Data collection and reporting
CRAs collect trial data from patients’ medical records and study-specific data collection forms, ensure review by appropriate clinicians and transcribe data to case report forms for data submission to sponsors.
- Quality assurance
CRSR Core staff ensure that trials are implemented in a consistent way and in compliance with all federal and local regulations.
- Information dissemination
Access to approved protocols and informed consent forms are made available through Oncore®. Monthly protocol cards listing trials that are actively enrolling patients are published and distributed to oncology physicians as well as to referring physicians within the VCUHS and the regional referral community. In addition, a more extensive list of clinical research studies that are active is published on Massey's website.
- Reporting on clinical trials activity
Registration and reporting of cancer-related trials through the Clinical Trials Reporting Program (CTRP) and clinicaltrials.gov is managed by the CRSR Core staff.
- Project management for investigator-initiated clinical trials
As concepts for clinical trials arise from Massey’s research programs. The CRSR Core personnel assist investigators by connecting them to clinical investigators with other experts/disciplines, such as other experienced clinical trialists, translational laboratory personnel, imaging experts, biostatisticians, scientific writers, etc., to move the concept to activation of the trial.
Revenue from grants, contracts and other funding sources earmarked to support cancer clinical research are used to reimburse the CRSR Core for its services.