Clinical Protocol and Data Management/Clinical Trials Office (Core-015)

Vanderbilt University Medical Center, Nashville TN

Investigators

Linked publications, trials & patents

Abstract

CORE 015: Clinical Protocol and Data Management; Data and Safety Monitoring; Inclusion of Women, Minorities and Children Project Summary The VICC Clinical Trials Shared Resource (CTSR) serves as a comprehensive resource to support adult and pediatric clinical research of the Cancer Center members ensuring timely and accurate protocol management. The CTSR continuously evaluates its systems to respond to the ever-changing landscape of clinical research now emphasizing increasingly complex genotype-driven trials. The CTSR assists investigators in all portions of clinical trial (CT) management, including financial, regulatory, data, screening, nursing management, imaging support and sample processing. The CTSR has dedicated budget and contracting analysts to negotiate budgets and contracts; regulatory staff to assist in preparation of all regulatory documents, including submissions to the Scientific Review Committee (SRC), the IRB, the Clinical Research Center (CRC), and IND submissions to the FDA. Scientific review, budgeting and contracting and regulatory submission occur in parallel, leading to an average time to final contract and Institutional Review Board (IRB) approval of 94 calendar days. Research staff report protocol deviations and Serious Adverse Event (SAE), while providing a robust data management team for all CTs. Additionally, Research Nurses support Investigators in the day-to-day protocol implementation, including consenting and patient visits. In response to the increasing complexity of biospecimen requirements, the Clinical Trial Processing Laboratory underwent a major redesign and is now processing more than 1100 specimens per month. The CTSR assists in patient accrual by screening new patients for CT eligibility and interacting with referring physicians to identify potential studies for them. VICC places highest priority on ensuring the safety of our patients participating in clinical research and provides a compliance team who performs monitoring and internal audits as outlined by the Data and Safety Monitoring Committee (DSMC). Additionally, CTSR provides investigator support for study registration and results reporting to ClinicalTrials.gov and the NCI Clinical Trials Reporting Program. Continuing its commitment to increasing diversity in clinical trials, VICC supported the recruitment of several key faculty whose work focuses on disparities and community engagement in clinical research. Since 2010, VICC sustained a 37% increase in accruals to interventional trials (699 to 961) and a 15% increase in therapeutic trials (581 to 666). Under the direction of the Medical Director, Vicki Keedy, MD, MSCI and the Director, Debra Wujcik, PhD, RN, the CTSR assists faculty in performing a large portfolio of CTs bringing innovative discoveries from the laboratory to clinical care.