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 kjarema@cc.nih.gov.
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
Biostatistics
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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