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Author East, Cara, author

Title Developing a successful clinical research program / Cara East
Published Cham, Switzerland : Springer, [2018]
Online access available from:
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Description 1 online resource
Contents Intro; Preface; Abbreviations; Contents; Chapter 1: Why Do Clinical Research?; 1.1 How Clinical Research Used to Be; 1.2 How Clinical Research Is Practiced Today; 1.3 Bench to Clinical: Mice, Humans, and Viagra; 1.4 Benefits: Prevention, Treatment, and New Therapies; 1.5 Reasons to Participate in Clinical Research; 1.6 Conclusion; References; Chapter 2: How Clinical Research Should Never Have Been Done: Ethical Measures for Protection and Respect; 2.1 The Nuremberg Code; 2.2 Unethical Medical Experimentation in the United States; 2.3 The Belmont Report; 2.3.1 Respect for Persons
2.3.2 Beneficence2.3.3 Justice; 2.4 Conclusion; References; Chapter 3: Choosing a Study; 3.1 Area of Interest; 3.2 Optimal Recruiting; 3.3 Consider the Staff; 3.4 Consider the Institution; 3.5 Consider the Mission; 3.6 Pay the Bills; 3.7 Change the World; 3.8 Expand Horizons; 3.9 Conclusion; References; Chapter 4: Starting a Clinical Research Team; 4.1 Medical Background; 4.2 Attention to Detail; 4.3 Lengthy Processes; 4.4 Characteristics of Research Staff; 4.5 The Clinical Trial Disclosure Agreement; 4.6 The Protocol; 4.7 The Sponsor and CRO; 4.8 Contract and Budget; 4.9 The Consent
4.10 Overview of Study Procedures4.11 Conclusion; References; Chapter 5: Developing a Budget; 5.1 The Initial Budget Overview; 5.2 Budget Per Subject; 5.3 Line Items; 5.4 Start-Up Costs; 5.5 Ongoing Study Line Items; 5.6 Sponsor and CRO Penalties; 5.7 Site Rewards; 5.8 Institutional Overhead; 5.9 Final Budget; 5.10 Long-Term Goal of the Budget; 5.11 Ongoing Study Payments; 5.12 Conclusion; Chapter 6: Negotiating a Contract; 6.1 Certifications; 6.2 The Protocol and Consent; 6.3 Documentation; 6.4 Compensation; 6.5 Subjects Enrolled; 6.6 Investigational Product; 6.7 Equipment; 6.8 Audits
6.9 Confidentiality and Intellectual Property6.10 Publications; 6.11 Termination and Indemnification; 6.12 Overview of the Contract; 6.13 Conclusion; References; Chapter 7: Writing a Great Consent; 7.1 Why Would You Want a Great Consent?; 7.2 A Signed Consent Is Not a Contract; 7.3 Writing the Consent; 7.4 Responsibility for the Consent; 7.5 The Consent Process; 7.6 The Belmont Report Relationship with the Consent; 7.7 Sponsor Approval of the Consent; 7.8 IRB Submission; 7.9 Consent Dates; 7.10 Consent Revisions; 7.11 New Procedures or Risks; 7.12 Consent Templates; 7.13 Conclusion; Reference
Chapter 8: Starting the Study8.1 Site Initiation Visit; 8.2 Mock Subject Drill; 8.3 Chart Templates; 8.4 Correction of Errors; 8.5 Study Update Meeting; 8.6 First Monitor Visit; 8.7 Conclusion; Chapter 9: Institutional Review Board (IRB); 9.1 Scientific Rationale; 9.2 Scientific Design; 9.3 IRB Exempt Review; 9.4 IRB Expedited Review; 9.5 IRB Full Board Review; 9.6 FDA Phases of Clinical Research; 9.7 Research Site Details; 9.8 Higher-Risk Activities; 9.9 Research Subjects; 9.10 Research Risks; 9.11 Subject Confidentiality and Payments; 9.12 Conclusion; References; Chapter 10: Recruiting
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
Bibliography Includes bibliographical references and index
Notes Vendor-supplied metadata
Subject Clinical trials.
Medicine -- Research.
Form Electronic book
ISBN 3319546937 (electronic bk.)
9783319546933 (electronic bk.)