Nonclinical Study Contracting and Monitoring

A Practical Guide

Edited by

  • William Salminen, PhD, DABT, PMP, PAREXEL International, Benton, AR
  • Joe Fowler, BS, RQAP-GLP, Director of the Quality Assurance Unit, National Center for Toxicological Research, FDA, Jefferson, AR
  • James Greenhaw, BS, LAT, Director of the Quality Assurance Unit, National Center for Toxicological Research, FDA, Jefferson, AR

Nonclinical Study Contracting and Monitoring: A Practical Guide offers a systematic and straightforward handbook for obtaining high quality preclinical Good Laboratory Practice (GLP) studies. This book is full of real-world examples, processes, procedures, useful templates, checklists and sample reports to provide readers with a better understanding of exactly what happens during all stages of a GLP study and the critical aspects of GLP study design and conduct. Designed for both the novice and experienced scientist, this book covers the GLP regulations and how they impact preclinical studies, the differences between GLP, non-GLP and peer-reviewed studies, preclinical GLP study design, laboratory selection, contracts and business ethics, how to obtain test material for the study, animal sourcing and release for study, preparation of a draft report and much more. By illustrating the overall big picture and tying it together with the individual steps, this book is an essential resource to help scientists ensure a high quality GLP study that passes both scientific and regulatory scrutiny.
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Audience

Toxicologists in pharmaceutical, agrochemical, food additive and industrial chemical industries, as well as study monitors, quality assurance unit (QUA) personnel, and other scientists who are responsible for contracting preclinical GLP studies with CROS and internal company laboratories.

 

Book information

  • Published: January 2013
  • Imprint: ACADEMIC PRESS
  • ISBN: 978-0-12-397829-5


Table of Contents

1. Introduction
2. Good Laboratory Practices
3. Study Design
4. Animal Welfare
5. Laboratory Selection
6. Project Proposal
7. Contracts and Business Ethics
8. Study Protocol, Preparation, Review, and Approval
9. Test Article
10. Study Start through End of In -Life
11. Study Communication and Data Management
12. A Study Director’s Perspective on Study Monitor-Study Director Interactions
13. Draft Report
14. Final Report, Study Close-Out, and Conclusions