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: hausmans@exchange.nih.gov
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