The specific aims of the Clinical Trials Core are 1) to assist investigators in the development and implementation of clinical translational trials conducted by projects within the SPORE; 2) to assist clinical investigators in the conduct of those clinical trials; 3) to ensure timely, accurate, and thorough collection and entry of clinical data into database management systems created and maintained by the Biomedical Informatics Core; 4) to monitor and assure the safety of research subjects, adherence to institutional and federal regulatory requirements, and compliance with protocol-specified activities; 5) to provide information, both on request and on an outreach basis, to patients, families, and health care professionals regarding clinical trials being conducted under this and other GI SPOREs; and 6) to monitor inquiries and track accrual to SPORE clinical trials. Establishment of a Clinical Trials Core will build upon already established mechanisms for clinical trial support at Vanderbilt including the Clinical Trials Shared Resource, the Clinical Protocol Review and Monitoring Committee of the VICCC, the VICCC Affiliate Network, and the Institutional Review Board of Vanderbilt University. The creation of a Clinical Trials Core within this GI SPORE grant is made necessary by the intensive needs and specialized nature of the clinical translational research projects described in this application.
Showing the most recent 10 out of 447 publications
