Nonclinical Study Contracting and Monitoring

Nonclinical Study Contracting and Monitoring

A Practical Guide

1st Edition - December 31, 2012

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  • Editors: William Salminen, Joe Fowler, James Greenhaw
  • Paperback ISBN: 9780123978295
  • eBook ISBN: 9780123978318

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Description

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

Readership

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

    Conclusion

    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

    Confidentiality

    Contracts

    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

    Necropsy

    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

    Reporting

    Conclusions

    Chapter 13. Draft Report

    Key Points

    Setting Expectations

    Receiving the Draft Report

    Sending Comments to the Laboratory

    Summary

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

    Key Points

    Finalizing the Report

    Amending the Final Report

    Study Close-Out

    Conclusions

    Index

Product details

  • No. of pages: 262
  • Language: English
  • Copyright: © Academic Press 2013
  • Published: December 31, 2012
  • Imprint: Academic Press
  • Paperback ISBN: 9780123978295
  • eBook ISBN: 9780123978318

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

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