Voluntary Standards for the Operation of Clinical Pharmacology Units
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0092-861997 Copyright 0 1997 Drug Information Association Inc.
VOLUNTARY STANDARDS FOR THE OPERATION OF CLINICAL PHARMACOLOGY UNITS GARYL. STEINMAN, MEEE Resident, GLS & Associates, New Preston, Connecticut
MD SUSANAR. K. DEDENNIS, Director. Abbott Clinical Pharmacology Research Unit. Waukeegan, Illinois
ALBERTJ. DIETZ,MD, PHD Clinical Research Manager, Upjohn Research Clinics, Kalamazoo, Michigan
DONNADOROZINSKY, RSN, RN Clinical Unit Manager, SmithKline Beecham Clinical Research Unit, Philadelphia, Pennsylvania
WILLIAML. HIRSCHHORN, MS Clinical Project Manager, Ciba-Geigy Clinical Research Unit, Philadelphia, Pennsylvania
MARIANA KIEFER-JOHNSON, MS, RN Clinical Research Manager, G. D. S e a r l n e Evanston Hospital Clinical Pharmacology Unit, Evanston, Illinois
HOWARDUDERMAN, MD Medical Director, Bristol-Myers Squibb Clinical Pharmacology Unit, Princeton, New Jersey
Clinical Pharmacology Units (CPUs) are a special class of clinical research units for investigating the pharmacokinetic,pharmacodynarnic,and toxicologicproperties of drugs in man. TheAssociation of Clinical Pharmacology Units (ACPU)is a national professional sociery with a membership drawn from academic and in-house pharmaceutical industry CPUs. It was established to provide a forum facilitating cooperation and the exchange of information and ideas between CPUs. One of its mujor objectives has been to promote the establishment of voluntary minimum standard of practice and guidelines for clinical pharmacology units. In October 1992, ACPU’s Standards Committee undertook to drafi a set of principles which would guide CPUs in the development of local standards and procedures. The product of this work was adopted by the membership in October 1994 afier several review and revision cycles. ACPU invites commentsfrom the clinical research community concerning its Voluntary Standards for the Operation of Clinical Pharmacology Units. Key Words: Clinical pharmacology units; Voluntary standards; Guidelines; Association of Clinical Pharmacology Units
Reprint address: Gary L. Steinman, GLS & Associates, Po Box 2197, New Preston, CT 06777.
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ACPU Standards Comminee
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ADMINISTRATION History,Mission, and Values CPU HISTORY, MISSION, values, and code of ethics should be documented clearly, reviewed periodically, and communicated regularly to staff to assure maintenance of knowledge and perspective concerning unit purpose, capability, and standards.
Host Institution The relationship of a CPU to its host or sponsoring institution should be defined and documented clearly, including administrative, medical, and scientific reporting lines. Host institution policies should be compatible with and supportive of unit mission and the relationship should provide: 1. Sufficient unit autonomy to permit accom-
plishment of mission and compliance with applicable standards, and 2. Effective agreements and procedures to assure the availability, reliability, and quality of host-provided serv
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