Developing a successful clinical research program /

Developing a successful clinical research program /

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Bibliographic Details
Author / Creator:East, Cara, author.
Imprint:Cham, Switzerland : Springer, 2018
©2018
Description:1 online resource
Language:English
Subject:
Clinical trials.
Medicine -- Research.
Biomedical Research.
Research Design.
Clinical Medicine.
Clinical Studies
Clinical trials.
Medicine -- Research.
Format: E-Resource Book
URL for this record:http://pi.lib.uchicago.edu/1001/cat/bib/11690213
Hidden Bibliographic Details
ISBN:9783319546933
3319546937
9783319546940
3319546945
9783319546926
3319546929
Digital file characteristics:text file PDF
Notes:Includes bibliographical references and index.
Vendor-supplied metadata.
Summary: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.
Other form:Print version: East, Cara. Developing a successful clinical research program. Cham, Switzerland : Springer, [2018] 3319546929 9783319546926
Standard no.:10.1007/978-3-319-54693-3
10.1007/978-3-319-54
Table of Contents:
  • Why Do Clinical Research?
  • How Clinical Research Should Never Have Been Done: Ethical Measures for Protection and Respect
  • Choosing a Study
  • Starting a Clinical Research Team
  • Developing a Budget
  • Negotiating a Contract
  • Writing a Great Contest
  • Starting the Study
  • Institutional Review Board (IRB)
  • Recruiting
  • Getting Subjects Through the Door
  • The Screening Visit
  • Follow-Up Subject Visits
  • Maintaining Subject Retention and Avoiding Study Fatigue
  • Adverse Events and Protocol Deviations
  • Contract Research Organizations and Monitors
  • Annual Reviews and Financial Disclosures
  • Finishing the Study
  • Staff Training and Incentives
  • Study Closeout
  • Acing an Audit
  • Expanding the Team
  • Appendix A: Sample Budget
  • Appendix B: Sample Informed Consents
  • Appendix C: Sample Recruiting Form
  • Appendix D: Sample Recruiting Pamphlet
  • Appendix E: Sample Adverse Events and Protocol Deviation Log
  • Appendix F: Sample Audit Forms
  • Appendix G: Sample Subinvestigator
  • Index

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