Writing Clinical Research Protocols

Writing Clinical Research Protocols

Ethical Considerations

1st Edition - August 4, 2005

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  • Authors: Evan DeRenzo, Joel Moss
  • Paperback ISBN: 9780122107511
  • eBook ISBN: 9780080454207

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Description

This highly engaging guide for clinical researchers provides a foundation for improving skills in the understanding of ethical requirements in the design and conduct of clinical research. Writing Clinical Research Protocols includes practical information on ethical principles in clinical research, designing appropriate research studies, writing consent and assent documents, getting protocols approved, special populations, confidentiality issues, and the reporting of adverse events. A valuable appendix includes a listing of web resources about research ethics as well as a glossary. This is an invaluable resource for basic scientists collaborating in clinical trials, physician investigators, clinical research fellows, research nurse coordinators, residents, and anyone who wants a better understanding of the clinical trials process.

Key Features

  • Walks investigators and trainees through identification of the ethical aspects of each section of a clinical research protocol
  • Includes a chapter containing Case Histories
  • Contains information on conducting clinical research within the pharmaceutical industry
  • An appendix includes internet resources and world wide web addresses for important research ethics documents and regulations
  • Chapter on 'Study Design and Methodology' purposely expanded to explicitly address biostatistical considerations

Readership

Basic scientists collaborating in clinical trials, physician investigators, clinical research fellows, research nurse coordinators, residents, and anyone who wants a better understanding of the clinical trials process.

Table of Contents

  • Section I. The Basics: What You Need to Know Before Starting Human Subjects Research

    1. Introduction to the Art and Science of Clinical Research
    2. What You Need to Know About Clinical Research Ethics
    3. What You Need to Know About the Regulation of Clinical Research
    4. Section II. Preparing the Protocol

    5. Designing a Clinical Research Study
    6. Selecting Subjects for Clinical Studies
    7. Risks and Benefits in Clinical Research
    8. Recruiting Subjects
    9. Informed Consent
    10. Privacy and Control
    11. The "Ethics" Section
    12. Section III. Procedures, Methods, Statistics, Data Management, and Record Keeping

    13. Procedures and Methods
    14. Statistics, Data Collection and Management, and Record Keeping
    15. Section IV. Special Issues

    16. Use of Human Biological Materials
    17. Special Issues Raised by Evolving Areas of Clinical Research
    18. Case Histories: Learning From Experience

    Appendix: Web Resources

    References

    Glossary

    Index

Product details

  • No. of pages: 320
  • Language: English
  • Copyright: © Academic Press 2005
  • Published: August 4, 2005
  • Imprint: Academic Press
  • Paperback ISBN: 9780122107511
  • eBook ISBN: 9780080454207

About the Authors

Evan DeRenzo

Evan DeRenzo works in the Center for Ethics at Washington Hospital Center, Washington, DC, USA

Affiliations and Expertise

Center for Ethics, Washington Hospital Center, Washington, DC, USA

Joel Moss

National Institutes of Health, Bethesda, MD, USA

Affiliations and Expertise

National Institutes of Health, Bethesda, MD, USA

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