NOT-AI-02-032: MONITORING OF CLINICAL TRIALS AND STUDIES

Department of Health
and Human Services (HHS)
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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" (http://grants.nih.gov/grants/guide/notice-files/NOT-AI-00-003.html).
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: 
http://www.niaid.nih.gov/ncn/pdf/clintermfy2002.pdf

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:
http://www.niaid.nih.gov/ncn/pdf/clinterm.pdf. Guidance information 
concerning the new policy will be available at: 
http://www.niaid.nih.gov/ncn/pdf/clintermguidance.pdf

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 http://www.niaid.nih.gov/ncn/staff/p-and-s.htm).

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: [email protected] or [email protected]
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