Clinical Protocol and Data Management

Roswell Park Cancer Institute Corp, Buffalo NY

Investigators

Linked publications, trials & patents

Abstract

The RPCI Clinical Protocol and Data Management/Clinical Trials Office (CPDM) is a comprehensive resource that provides a full range of clinical research services for all RPCI investigators at all RPCI clinical sites and in the clinical sites of its affiliates. CPDM is directed by Joyce Yasko, PhD, with Assistant Director Laurie Musial RN, MS and overseen by Alex Adjei, MD, PhD, Associate Director for Clinical Research. CPDM provides resources and oversight for the development, review, implementation, and conduct of clinical research studies and tracks regulatory documents. In collaboration with the study principal investigator, CPDM submits studies and amendments to the Scientific Review Committee (SRC) and Institutional Review Board (IRB) and submits continuing reviews to the IRB. CPDM also provides administrative support for the Clinical Research Prioritization and Feasibility Committee (CRPC), Scientific Review Committee (SRC), Response Review Committee (RRC), Phase I Committee and the Data and Safety Monitoring Board (DSMB). CPDM prepares, negotiates and manages study budgets and contracts; provides study sponsors and regulatory agencies with all required study documents; coordinates the conduct of all RPCI clinical studies and ensures that complete and accurate study data are collected and entered into a centralized electronic research database (eClinical). CPDM also ensures that all adverse events are reported promptly and accurately. In CY 2012, CPDM managed 213 active intervention studies with an accrual of 870 participants (1235 consented accrual) and 256 non-intervention studies with an accrual of 591,727 participants. The RPCI Data & Safety Monitoring Board (DSMB) coordinates and provides oversight for data and safety monitoring for all treatment intervention studies consistent with the NIH Policy for Data and Safety Monitoring dated June 10, 1998. The revised Roswell Park Cancer Institute Data & Safety Monitoring Plan (DSMP) was approved by the National Cancer Institute on April 4, 2011