The Preston Robert Tisch Brain Tumor Center Clinical Research Team conducts a variety of research efforts to support principal investigators. The team is comprised of research nurses, clinical trial coordinators, data managers and regulatory staff, and has experience in enrollment to Phase 1, Phase 2, Phase 3, Supportive Care and Quality of Life studies. The team collaborates with physician investigators and basic scientists to translate lab science and discoveries into Phase 1 clinical trials.
Research Nurses and Clinical Research Coordinators
Clinical research nurses and coordinators are responsible for keeping each phase of the trial on track, and must possess sharp organizational and operational skills in order to adhere to detailed protocols. They oversee a variety of procedures, including (but not limited to) recruiting patients, facilitating participant care and follow-ups, maintaining sponsor compliance and adherence to FDA regulations, and collecting data. Providing optimal patient care and keeping trial records accurate and up-to-date, our clinical research nurses and coordinators help make more effective treatment methods possible.
Data Management Team
Members of the Data Management Team (DMT) combine their medical and information technology (IT) experience to operate a complex data management system within The Preston Robert Tisch Brain Tumor Center. Among other duties, the DMT collects data from patient charts, medical records, interviews, questionnaires, diagnostic tests, and other sources. The DMT then codes this collected data and prepares appropriate documentation, enters data into study-specific data repositories, and assures that all blood samples, cultures, tissues and other specimens for laboratory analyses are obtained and collected per protocol. The team strives together to improve clinical research via data management and development of novel IT strategies.
The Regulatory Team is responsible for submitting and maintaining the necessary documentation in order to conduct clinical trials in both a compliant and safe manner. The team communicates with the Food and Drug Administration, the Duke Institutional Review Board, the Duke Cancer Protocol Committee, and external review boards, as well as other regulatory committees both internal and external to Duke. They also work with sponsors and supporters of Duke’s clinical trials to facilitate the opening of new trials, maintain regulatory compliance of current trials, and close trials at their completion. The Duke Office of Regulatory Affairs and Quality staff supports the FDA Regulatory submission process for all applicable trials and works collaboratively with The Preston Robert Tisch Brain Tumor Center's Regulatory team.