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Developing a Successful Clinical Research Program

  • Cara¬†East

Table of contents

  1. Front Matter
    Pages i-xix
  2. Cara East
    Pages 1-10
  3. Cara East
    Pages 19-25
  4. Cara East
    Pages 27-36
  5. Cara East
    Pages 37-44
  6. Cara East
    Pages 45-52
  7. Cara East
    Pages 53-62
  8. Cara East
    Pages 63-67
  9. Cara East
    Pages 69-76
  10. Cara East
    Pages 77-82
  11. Cara East
    Pages 83-88
  12. Cara East
    Pages 89-99
  13. Cara East
    Pages 101-107
  14. Cara East
    Pages 119-125
  15. Cara East
    Pages 145-148
  16. Cara East
    Pages 149-162
  17. Cara East
    Pages 163-170
  18. Cara East
    Pages 171-180
  19. Cara East
    Pages 181-187
  20. Back Matter
    Pages 189-270

About this book

Introduction

This unique book is designed to help a medical team become a clinical research team. It includes practical information and tips for the initial stages of clinical research: building a team, negotiating a contract, developing a budget, and writing and improving a patient consent. Chapters describing the nuts and bolts of how to actually perform the study follow, including patient recruiting and retention, screening, follow-ups and handling monitor visits. Finally, there is discussion of the yearly reviews and disclosures and not just surviving, but acing, the all-important Food and Drug Administration audit.

Clinical research moves medicine forward and is a necessary part of bringing any new therapy, device, or procedure into routine medical care. However, it can be costly and convoluted, and the methodologies of clinical research are not widely standardized. Decreasing some of the chaos present in American clinical research is the primary goal of this book. The second goal is to improve the understanding and education of those who enter clinical research, whether in the frontline work of the clinical research site, in the middleman companies who have a high turnover rate, at a research hospital or institution, or at medical corporations that depend on good clinical research to bring their products to market. The third reason is to standardize American clinical research and to remove some of the vagaries and inconsistencies in the field.

Practical and user-friendly, Developing a Successful Clinical Research Program fills a need for a clear guide to developing and improving a first-class research program in any clinical setting. 

Keywords

Adverse event Auditing Budgeting Clinical research team Clinical staff training Clinical trials Contract negotiation Financial disclosure Informed consent Medical study Patient recruiting Regulatory review Research methodology Screening visit Subject retention Subject screening

Authors and affiliations

  • Cara¬†East
    • 1
  1. 1.Baylor Soltero CV ResearchBaylor University Medical CenterDallasUSA

Bibliographic information

  • DOI https://doi.org/10.1007/978-3-319-54693-3
  • Copyright Information Springer International Publishing AG, part of Springer Nature 2018
  • Publisher Name Springer, Cham
  • eBook Packages Medicine
  • Print ISBN 978-3-319-54692-6
  • Online ISBN 978-3-319-54693-3
  • Buy this book on publisher's site
Industry Sectors
Pharma
Health & Hospitals
Biotechnology