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Clinical Research Shared Resource
John D. Roberts, M.D.
Resource director
Martha D. Wellons
Assistant resource director
Phone: (804) 828-0450
Overview
The Clinical Research Shared Resource Facility consists of the director, the Office for Clinical Research (centralized protocol office), eight clinical research teams and a computer programmer/analyst team.
The role of the Office for Clinical Research is to support cooperative group and locally initiated research through the performance of centralized functions, to promote locally initiated research through support for investigators in the development and conduct of research, to facilitate communication concerning cancer-related clinical trials throughout the institution and to assure high-quality clinical research, in part through support for the Clinical Trials Review Committee and its subcommittee, the Monitoring Committee.
Services
This shared resource facility provides conceptual development for the clinical research database that currently tracks the regulatory and accrual status of all institutional cancer-related clinical trials.
Future work will direct expansion of this database to capture patient/subject-specific clinical data from other databases of the institution through the VCU Massey Cancer Center Information System. The clinical research database is used to generate reports concerning institutional cancer-related clinical research.
- Publishes monthly clinical trials menu cards.
- Maintains libraries of active trials in multiple sites of cancer-related clinical activity throughout the institution.
- Coordinates meetings of the various components of the shared resource.
- Manages the travel budget and travel arrangements.
- Handles internal (Office of Sponsored Programs, IRB, General Clinical Research Center, Radiation Safety Committee, Clinical Trials Review Committee) and external (NCI, OPRR, other NIH, FDA, cooperative group, industry) regulatory, granting and contractual affairs.
- Assists potential investigators in the writing of grant, agreement and contract applications.
- Acts as the liaison between investigators and sponsors.
- Provides administrative and clerical support for the Clinical Trials Review Committee and its Monitoring Committee.
- Creates all informed consent forms used to enroll subjects upon clinical trials on the day of use.
- Manages patients/subjects and data for clinical trials and other clinical research project.
Teams
Within eight registered nurse/clinical research assistant teams, the registered nurses assure that research procedures are accomplished within a context of high-quality patient/subject care. The role of the registered nurse includes participation in the informed consent process as well as ongoing patient/subject education, coordination of clinical interventions, coordination with the investigational pharmacy, systems “trouble shooting” and ongoing patient/subject assessment, especially assessment and management of toxicities. The clinical research assistants assure that research documentation procedures are accomplished. Clinical research assistants are responsible for eligibility assurance, adherence to study schedules, the development of patient-specific calendars, acquisition of test results and maintenance of the research record, the completion and filing of case report forms, preparation for audits, and generation of reports.
- Hematology oncology phase I team – consists of a registered nurse coordinator, a registered nurse and three clinical research assistants. The team supports participation of hematologists/oncologists in two NCI-sponsored cooperative groups, CALGB and the M.D. Anderson Community Oncology Program, and many or most pilot/phase I trials regardless of discipline.
- Surgical oncology team – consists of a registered nurse coordinator, and one full-time and one part-time clinical research assistant. The team supports participation of surgical oncologists in NSABP and occasional other trials.
- Cancer control team – consists of a registered nurse and two clinical research assistants. The team supports participation of diverse investigators in cancer control studies of four NCI-sponsored cooperative groups: CALGB, M.D. Anderson Community Oncology Program, University of Rochester Cancer Control Program and NSABP.
- Radiation oncology team – consists of one registered nurse. It supports participation of radiation oncologists in RTOG and locally initiated clinical trials.
- Gynecologic oncology team – consists of a clinical research assistant who coordinates closely with the clinical/research registered nurse staff of the gynecologic oncology program; in addition, the registered nurse coordinator from surgical oncology serves as consultant research registered nurse for this team. It supports participation of gynecologic oncologists in GOG.
- Bone marrow transplantation team – consists of two clinical research assistants who coordinate closely with the clinical/research registered nurse staff of the Bone Marrow Transplantation Program. It supports participation in NCI-sponsored cooperative group trials of CALGB and POG, other NIH-sponsored trials, and the National Marrow Donor Program.
- Pediatric oncology team – consists of a clinical research assistant who coordinates closely with the clinical/research registered nurse staff of the Pediatric Oncology Program. It supports participation in POG.
- Neuro-oncology team – consists of one registered nurse. It supports participation of neurosurgeons, medical oncologists and radiation oncologists in the M.D. Anderson Community Oncology Program, an FDA-funded glioma trial, and locally initiated trials.
