Developing a successful clinical research program. ([2018])

• Record Type: Book
• Further Information: Note: Cara East.
• Authors: East, Cara
• 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
• Publisher Details: Cham, Switzerland : Springer
• Publication Date: 2018
• Copyright Date: 2018
• Extent: 1 online resource
• Subjects: 610.72/4; Medicine; Clinical trials; Medicine -- Research; HEALTH & FITNESS / Holism; HEALTH & FITNESS / Reference; MEDICAL / Alternative Medicine; MEDICAL / Atlases; MEDICAL / Essays; MEDICAL / Family & General Practice; MEDICAL / Holistic Medicine; MEDICAL / Osteopathy; Clinical trials; Medicine -- Research; Medicine & Public Health; Medicine/Public Health, general; Medical -- General; Medicine: general issues; Electronic books
• Languages: English
• ISBNs: 9783319546933; 3319546937
• Related ISBNs: 9783319546926; 3319546929
• Notes: Note: Includes bibliographical references and index.; Note: Vendor-supplied metadata.
• Access Rights: Legal Deposit; Only available on premises controlled by the deposit library and to one user at any one time; The Legal Deposit Libraries (Non-Print Works) Regulations (UK).
• Access Usage: Restricted: Printing from this resource is governed by The Legal Deposit Libraries (Non-Print Works) Regulations (UK) and UK copyright law currently in force.