Clinical Protocol and Data Management

CLINICAL PROTOCOL AND DATA MANAGEMENT ABSTRACT The goal of Clinical Protocol and Data Management (CPDM) at Roswell Park is to assist investigators in the development, implementation, conduct, completion, and reporting of clinical trials in a scientifically rigorous and regulatory compliant manner. This goal is carried out by Clinical Research Services (CRS), a centralized resource that oversees a broad portfolio of clinical trials, including institutional trials (e.g., investigator-initiated trials or IITs), trials in association with national clinical trial networks (LAPS/NCTN), other National Cancer Institute (NCI)-sponsored trials (ETCTN, CITN, EDDOP, COG), I-SPY Network and industry-sponsored trials. CPDM staff assist investigators in assembling clinical and scientific content for protocols, developing budgets, and facilitating timely initiation and completion of trial activities such as effective protocol reviews and implementation. Training and educational materials are provided to all faculty and staff engaged in clinical trial activities. CPDM oversight of clinical research extends to submission of the protocol, development of amendments, and continuing reviews in conjunction with the Scientific Review Committee (SRC) and Institutional Review Board (IRB), quality assurance, and management and tracking of all regulatory documents. CPDM staff provide critical administrative support to the Clinical Disease Teams (CDTs) for protocol prioritization and assessments of ongoing scientific relevance, and for interactions with the SRC (see Protocol Review and Monitoring System) and Data and Safety Monitoring Committee (DSMC). The work of CPDM is organized around four specific aims: 1. Provide central infrastructure foundational to collaboration and productivity, including a clinical trial management system and technical staff to support Roswell Park investigators in their efforts to promote efficient and effective clinical trial development, timely activation, and outcome reporting. 2. Ensure excellence in clinical research performance through training and education in accordance with the highest standards of conduct, applicable regulations, policies, and procedures. 3. Deliver appropriate oversight and monitoring of all cancer-related Roswell Park clinical trials, thus ensuring participant safety, data integrity, and the quality and reproducibility of the findings. 4. Coordinate and cultivate multi-investigator, transdisciplinary, and multi-institutional partnerships to promote and facilitate access to and implementation of clinical trials within the Roswell Park catchment area, State of New York, and beyond.