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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