Roswell Park Cancer Institute (RPCI) is dedicated to the safety of patients participating in clinicalresearch studies, study compliance, and data integrity. The guidelines presented here pertain to the dataand safety monitoring of all RPCI phase II and Pilot studies. RPCI phase I studies are monitored weekly bythe RPCI Phase I Committee. Study-specific plans vary based on the degree of risk involved in participationand the size and complexity of the clinical research study. The development of study monitoring plans andreporting requirements are influenced by the study sponsor, the nature of the investigational agent, and thephase 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 safetymonitoring for all therapeutic trials consistent with the NIH Policy for Data and Safety Monitoring datedJune 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, withStephen 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 thisResource provides continuing support for ongoing implementation and conduct of the DSMP. Data andSafety Monitoring responsibilities encompass three areas: support for the formation and maintenance of aData and Safety Monitoring Board (DSMB), performance of regular audits of clinical research studies forstudy compliance and data quality and the ongoing monitoring of reported adverse events.
Showing the most recent 10 out of 1555 publications
