Implementation of Data Safety Monitoring Plan (DSMP)

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The Roswell Park Cancer Institute (RPCi) is an NCI-designated comprehensive cancer center which conducts extensive preclinical and clinical research in cancer etiology, prevention, and treatment. The Office of Institutional Protocols and Scientific Integrity (OIPSI) is the RPCI office responsible for oversight of processes that insure protection of human subjects and conduct of clinical research according to the highest principles of scientific practice and compliance and supports the Institute Scientific Review Committee (SRC) and the Institutional Review Board (IRB). This office manages more than 130 new protocols and 425 amendments each year. Recent recruitment in preclinical and clinical sciences are proceeding so successfully that we estimate a substantial increase in clinical research activity over the next 2-3 years, in addition, RPCI is committed to implementing the most modem and complete program in clinical research management possible. In accordance with the guidelines of the National Cancer Institute Office of Deputy Director for Extramural Science, RPCI has implemented a plan for Data Safety Monitoring. This plan provides a comprehensive scheme for conduct and oversight of human subjects research at RPCI. The objective of this proposal is to develop information technologies that support the implementation of this plan. This implementation will proceed in three phases: Specific Aim 1: update automation of existing documentation of protocols for scientific review and 1RB approval covering protocols currently accruing patients in co-operative programs or investigator-initiated studies; Specific Aim 2: implement the auditing system with automated compliance monitoring documentation to insure regular monitoring of subjects in approved studies; Specific Aim 3: establish an FDA and HIPAA compliant internal web-based system for adverse event reporting (ADR) that will allow for reat time reporting of adverse events and the creation of an adverse event database for the Iongterm monitoring and investigational profiling of adverse events. Implementation of these specific aims will provide system enhancements that will assure compliance of RPCI protocols with the highest standards and guidelines for protection of human subjects and conduct of clinical research.