Roswell Park Cancer Institute (RPCI) is dedicated to the safety of patients participating in clinical research studies, study compliance, and data integrity. The guidelines presented here pertain to the data and safety monitoring of all RPCI phase II and Pilot studies. RPCI phase I studies are monitored weekly by the RPCI Phase I Committee. Study-specific plans vary based on the degree of risk involved in participation and the size and complexity of the clinical research study. The development of study monitoring plans and reporting requirements are influenced by the study sponsor, the nature of the investigational agent, and the phase of the study. Each RPCI phase II and Pilot study must contain a plan for data and safety monitoring. The RPCI Data &Safety Monitoring Board coordinates and provides oversight for data and safety monitoring for all therapeutic trials consistent with the NIH Policy for Data and Safety Monitoring dated June 10, 1998, and updated June 22, 1999 and June 5, 2000. The Roswell Park Cancer Institute Data & Safety Monitoring Plan (DSMP) was approved by the National Cancer Institute on March 23, 2002. Data &Safety Monitoring is led by Alex Adjei MD, PhD, Associate Director for Clinical Research, with Stephen B. Edge, MD, functioning as the Chairperson of the Data and Safety Monitoring Board (DSMB). Clinical Research Services (CRS) provides the administrative support for the DSMB. Funding for this Resource provides continuing support for ongoing implementation and conduct of the DSMP. Data and Safety Monitoring responsibilities encompass three areas: support for the formation and maintenance of a Data and Safety Monitoring Board (DSMB), performance of regular audits of clinical research studies for study compliance and data quality and the ongoing monitoring of reported adverse events.

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