MONITORING OF CLINICAL TRIALS AND STUDIES - NIAID Release Date: July 8, 2002 NOTICE: NOT-AI-02-032 National Institute of Allergy and Infectious Diseases (NIAID) Effective Date of New Monitoring Policy: October 1, 2002 Notice AI-00-003 in the February 25, 2000 NIH Guide announced the availability of "NIAID POLICY ON MONITORING GRANTS SUPPORTING CLINICAL TRIALS AND STUDIES" ( Standard NIAID Terms and Conditions of Award for clinical studies and trials were promulgated. These terms and conditions of award will remain in effect until September 30, 2002 will be found at: Since that time, there have been many changes in policy concerning the appropriate conduct of clinical research. As a result, NIAID is updating its policy and announcing the availability of updated "Clinical Terms of Award" that will become effective on October 1, 2002. Awardees will be required to comply with these updated Clinical Terms of Award. The terms will be incorporated in their Notices of Grant Award or contracts. These terms require that all clinical trials and studies supported by NIAID be monitored commensurate with the degree of potential risk to study subjects and complexity of the study. The details of the new policy can be found at the following location: Guidance information concerning the new policy will be available at: INQUIRIES Inquiries about a specific grant, cooperative agreement, or contract should be directed to the NIAID Program Officer for that award. For all applications and grants, the Program Officer is identified in the upper left corner of the first page of the summary statement. Inquires about potential applications or proposals should be directed to the appropriate NIAID staff member (See General inquiries related to this notice may be directed to: Director Division of Extramural Activities, NIAID Room 2142, 6700-B Rockledge Drive MSC 7610 Bethesda, MD 20892-7610 Telephone: (301) 496-7291 FAX: (301) 402-0369 E-mail: or

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