Clinical Research Services (CRS) is a CCSG Resource critical to the execution of the clinical and translational research programs of Roswell Park Cancer Institute (RPCI). CRS is a comprehensive program that provides a full range of research services for all RPCI investigators at all RPCI clinical sites and in the clinical sites of its affiliates. It is directed by Joyce Yasko, PhD, VP Clinical Research Administration and Services and overseen by Alex Adjei, MD, PhD, Associate Director for Clinical Research. CRS provides resources and oversight for the development, review, implementation, and conduct of clinical research studies;tracks regulatory documents and submits studies and amendments to the Scientific Review Committee (SRC) and Institutional Review Board (IRB) and continuing reviews to the IRB. Dr Yasko defines the role and responsibilities;establishes the standard operating procedures and facilitates the orientation and ongoing education of the CRS staff. CRS includes 40 FTE Clinical Research Coordinators under the supervision of Linda Schmieder, RN, MSN, Director, Study Implementation;12 FTE regulatory research associates under the supervision of Julie Haney, RN, BS, Director, Study Submission and Regulatory Affairs and 6 FTE compliance staff under the supervision of Janet Pantano, RN, BSN, Director, Compliance. In addition, CRS has a Clinical Research Network under the supervision of Mary Eileen McPhee, RN, MSN, Director, RPCI Clinical Research Network. The Network is responsible for the implementation of clinical research in locations external to RPCI. CRS also provides support for the SRC, Response Review Committee, Phase I Committee and the Data and Safety Monitoring Board;prepares, negotiates and manages study budgets;provides study sponsors and regulatory agencies with all required study documents;coordinates the conduct of all RPCI studies and ensures that complete and accurate study data are collected and entered into a centralized electronic research database (eRT). CRS also ensures that all adverse events are reported promptly and accurately. In CY 2006, CRS managed 256 active intervention studies with an accrual of 906 participants and 233 non-intervention studies with an accrual of 11,953 participants. $155,187 in CCSG support is requested, representing 3% of the total operating budget.
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