guide for preparing and conducting clinical research study

Note from the Editor

As the general editor for this edition of "Protomechanics," I would like to thank the individuals listed below for their time and important contributions. "Protomechanics" is designed as a reference guide to assist investigators in the development of research protocols. Changes, revisions or modifications will be incorporated into future editions, and may be submitted to Kim Jarema, Chief, Protocol Coordination Service Center at 435-2401, or via e-mail at

Mai Khuu, RRA
General Editor
Protocol Coordination Service Center, CC

John Decker, M.D.
Director Emeritus, Clinical Center
Author and Contributing Editor

John I. Gallin, M.D.
Director, Clinical Center
Contributing Editor

Contributing Subject Matter Experts

Debra Byram, R.N.
Nursing Department, CC
Clinical Center Resource Use
Protocol Mapping

Bernice Crossley, R.N.
Medical Record Department, CC
Medical Information System
Predefined Order Sets

Charles Daniels, Ph.D.
George Grimes, P.D.
Pharmacy Department, CC
Investigational New Drugs and Devices
FDA Reporting
Drug Development

Cynthia Dunbar, M.D., NHLBI
Harry Malech, M.D., NIAID
Robert Walker, M.D., NIAID
Human Gene Therapy
Institutional Biosafety Committee
Office of Recombinant DNA Activities
Recombinant-DNA Advisory Committee

Janet Smith
Office of Human Subjects Research
Federal Regulations
Internal Scientific Review
Institutional Review Boards
Single and Multiple Project Assurance

Seth Steinberg, Ph.D., NCI
Statistical Considerations
Power Determination
Meta Analysis

Carol Verderese, R.N.
Office of Financial Resources Management, CC
Clinical Center Resource Use
Protocol Mapping

David Wendler, M.D.
Department of Clinical Bioethics, CC
Advance Directives
Durable Power of Attorney

In addition, there were many others who provided important input into this edition, including the Institutional Review Board Chairs and the Institute Clinical Directors.

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