Nonclinical Study Contracting and Monitoring
A Practical Guide

A hands-on guide complete with checklists, practical examples and sample reports to assist readers with the challenges of ensuring high-quality GLP studies.

William F. Salminen (Edited by), Joe M. Fowler (Edited by), James Greenhaw (Edited by)

9780123978295

Paperback / softback, published 22 February 2013

262 pages
22.9 x 15.1 x 1.7 cm, 0.43 kg

"I particularly liked the detailed checklists that are provided throughout the book…this book is an excellent practical guide on how to perform, contract, monitor and report nonclinical studies.  It is well presented and easy to read and will be particularly useful for beginning study monitors and toxicologists." --British Toxicology Society, Issue 43, Winter 2013

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.

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

Subject Areas: Molecular biology [PSD], Pharmacy / dispensing [MQP], Medical toxicology [MMGT], Medical laboratory testing & techniques [MBGL]