GUIDELINES FOR INVESTIGATOR-INITIATED CLINICAL TRIALS - NIAMS

Release Date:  August 16, 2000

NOTICE:  AR-00-003

National Institute of Arthritis and Musculoskeletal and Skin Diseases

The purpose of this Notice is to announce the availability of the "Guidelines 
for Submission of Applications for Investigator-Initiated Clinical Trials."  
This document outlines the NIAMS policy and procedures for investigator-
initiated clinical trials and provides guidelines for the preparation and 
submission of these applications.  It lists the requirements placed on the 
receipt, review, and funding of these applications and presents guidelines for 
the conduct of such trials.  These guidelines apply to investigator-initiated 
clinical trials irrespective of the grant mechanism being used (e.g., R01, 
P01, P50, P60, etc.).  An application for a clinical trial should be submitted 
as a whole rather than applications from individual sites or components.  
Clinical trials submitted as projects in a P50 (Specialized Center of 
Research) or P60 (Multidisciplinary Clinical Research Center) should follow 
the application format described in these guidelines (Section C) and include a 
discussion of data safety and monitoring (Section D).  

This document may be found at the following location:
http://www.nih.gov/niams/grants/gsaiict.htm

INQUIRIES

General inquiries related to this notice may be directed to:

Steven J. Hausman, Ph.D.
Director, Extramural Program, NIAMS
Natcher Building, RM 5AS13F
45 Center Drive  MSC 6500
Bethesda, MD  20892
Telephone: (301) 594-2463
FAX: (301) 480-4543
Email: [email protected]

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