Army Drug Development Program. Phase I. Clinical Testing.
Abstract
In the period from 15 February 1975 to 18 August 1983 Bio-Med, Inc. was involved in the following activities; (1) Consultation with the Division of Experimental Therapeutics at the Walter Reed Army Institute of Research (WRAIR) regarding drugs under development. (2) The development of protocols for Phase I Clinical Studies and the administrative and technical processing of these protocols including (a) appropriate scientific consultation regarding medical aspects of the studies, (b) institutional review including review of the protocol by a duly constituted Institutional Review Board, and (c) submission of the protocol(s) to the sponsoring agency for their internal review mechanisms. (3) The implementation of protocols which included subject recruitment, identification and medical qualification; the provision for the clinical environment for the conduct of the study including the nursing, dietetic, laboratory and custodial services; the conduct of the study including immediate medical supervision of drug administration, subject evaluation and specimen collection; the timely analysis of prescribed procedures such as EOGs, roentegenograms, etc.; and the medical follow-up of each subject and his eventual separation from the study.
Document Details
- Document Type
- Technical Report
- Publication Date
- Oct 01, 1983
- Accession Number
- ADA148820
Entities
People
- K. G. Barry
- L. B. Altstatt
- R. C. Reba