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Nonclinical Study Contracting and Monitoring - 1st Edition - ISBN: 9780123978295, 9780123978318

Nonclinical Study Contracting and Monitoring

1st Edition

A Practical Guide

Editors: William Salminen Joe Fowler James Greenhaw
Paperback ISBN: 9780123978295
eBook ISBN: 9780123978318
Imprint: Academic Press
Published Date: 31st December 2012
Page Count: 262
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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.

Key Features

  • Includes both the "big picture" look at complex processes, such as contracting toxicology and safety studies with CROs, as well as a detailed account of each individual step.
  • Contains several real world examples of problems in preclinical studies to provide you with an idea of the types of challenges that are routinely encountered and how this book can help you avoid these issues.
  • Provides monitoring checklists through the book that will help you comply with each GLP requirement and maintain compliance throughout the entire process.
  • Both entry level and experienced scientists involved in nonclinical toxicology study monitoring will benefit from the ideas, examples, discussions and strategies presented throughout this book.


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.

Table of Contents

List of Contributors

Chapter 1. Introduction

Key Points

GLPs and Nonclinical Studies

CROs and Nonclinical Studies

Study Directors

Examples of Study Issues


Chapter 2. Good Laboratory Practices

Key Points

US FDA (21 CFR Part 58) and OECD GLPs

Subpart A – General Provisions

Subpart B – Organization and Personnel

Subpart C – Facilities

Subpart D – Equipment

Subpart E – Testing Facilities Operation

Subpart F – Test and Control Articles

Subpart G – Protocol for and Conduct of a Nonclinical Laboratory Study

Subpart J – Records and Reports

GLP Facility Inspections

GLP Auditing Checklist

Chapter 3. Study Design

Key Points

General Study Design Issues

Study Design Checklist

Chapter 4. Animal Welfare

Key Points

The “Guide”

Regulations Established by the USDA Under the AWA

Potential Conflicts Between the Animal Welfare Requirements, GLPs, and Other Study Requirements

Animal Welfare Checklist

Chapter 5. Laboratory Selection

Key Points

Contacting and Preliminary Screening of a New Laboratory

Visiting and Auditing a New Laboratory

Laboratory Selection Checklist

Chapter 6. Project Proposal

Key Points

Detailed Study Outline

Price Negotiation

Detailed Study Outline Template

Chapter 7. Contracts and Business Ethics

Key Points



Maintaining Confidentiality During the Study

Business Ethics

Example of a Confidential Disclosure Agreement

Chapter 8. Study Protocol Preparation, Review, and Approval

Key Points

Writing the First Draft

Reviewing the Draft Protocol

Finalizing the Protocol

Changing the Finalized Protocol

Protocol Checklist

Chapter 9. Test Article

Key Points

Test and Control Article Synthesis and Sourcing

Test and Control Article Characterization

Mixtures of Test Articles

Test Article and Mixture Receipt, Storage, and Tracking

Additional Considerations

Chapter 10. Study Start Through End of In-Life

Key Points

Test Article and Formulations

Acquiring Animals

Pre-Study Meeting

First Day of Dosing

Protocol Deviations and Amendments

Study Updates, Data Auditing, and GLP Compliance


Chapter 11. Study Communication and Data Management

Key Points

Handling Issues that may Arise

Data Management

Study Reports and Archiving

Communicating Study Results

Study Audit Template

Chapter 12. A Study Director’s Perspective on Study Monitor–Study Director Interactions

Key Points

Establishing the Working Relationship

Setting Your Expectations

The Study Director’s Expectations of You

Pre-protocol Communications

Protocol Development

The Pre-Study Meeting

Visiting the Laboratory

Study Updates

Study Issues and the Unexpected



Chapter 13. Draft Report

Key Points

Setting Expectations

Receiving the Draft Report

Sending Comments to the Laboratory


Chapter 14. Final Report, Study Close-Out, and Conclusions

Key Points

Finalizing the Report

Amending the Final Report

Study Close-Out




No. of pages:
© Academic Press 2013
31st December 2012
Academic Press
Paperback ISBN:
eBook ISBN:

About the Editors

William Salminen

Affiliations and Expertise

PhD, DABT, PMP, PAREXEL International, Benton, AR

Joe Fowler

Affiliations and Expertise

BS, RQAP-GLP, Director of the Quality Assurance Unit, National Center for Toxicological Research, FDA, Jefferson, AR

James Greenhaw

Affiliations and Expertise

BS, LAT, Director of the Quality Assurance Unit, National Center for Toxicological Research, FDA, Jefferson, AR


"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

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