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📙 A Clinical Trials Manual from the Duke Clinical Research Institute: Lessons From A Horse Named Jim, Second Edition by Margaret B. Liu, Kate Davis(auth.) — pdf free


Content:
Chapter 1 Lessons from a Horse Named Jim and Other Events in History Affecting the Regulation of Clinical Research (pages 1–11):
Chapter 2 The Process: Developing New Drugs, Biologics, and Devices (pages 13–48):
Chapter 3 Good Clinical Practice and the Regulations (pages 49–72):
Chapter 4 Informed Consent and the Regulations (pages 73–100):
Chapter 5 Institutional Review Boards (pages 101–121):
Chapter 6 Adverse Events and Unanticipated Problems Involving Risks to Subjects or Others (pages 123–139):
Chapter 7 Monitoring, Audits, and Inspections (pages 141–162):
Chapter 8 The Principal Investigator, the Clinical Research Coordinator, and the Study Site (pages 163–176):
Chapter 9 The Protocol (pages 177–198):
Chapter 10 Study Feasibility: Reviewing a Specific Protocol (pages 199–212):
Chapter 11 Study Activities (pages 213–244):
Chapter 12 Study Documents/Essential Documents (pages 245–269):
Chapter 13 Management of Study Drugs, Biologics, and Devices (pages 271–279):
Chapter 14 Managing Clinical Trial Data (pages 281–311):
Chapter 15 Global Health and International Trials (pages 313–324):

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