MONITORING OF CLINICAL TRIALS Release Date: August 16, 1999 P.T. National Cancer Institute The purpose of this Notice is to announce the availability of the "Policy of the National Cancer Institute for Data and Safety Monitoring of Clinical Trials." The policy requires that all clinical trials supported or performed by NCI be monitored in some form commensurate with the degree of risk involved in participation and complexity of the clinical trial. Monitoring exists on a continuum from monitoring by the principal investigator/project manager to a data and safety monitoring board (DSMB). All Phase III randomized clinical trials supported or performed by NCI require monitoring by a DSMB. The organization, responsibilities, and operation of the DSMBs are described in the policy. The details of this policy including requirements for data safety and monitoring can be found at the following location: http://deainfo.nci.nih.gov/grantspolicies/datasafety.htm INQUIRIES General inquiries related to this notice may be directed to: Richard Mowery, Ph. D. National Cancer Institute Executive Plaza North, Suite 712 Bethesda, MD 20892-7424 Telephone: (301) 496-0510 FAX: (301) 480-2642 Email: rm33a@nih.gov
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