Summary and Info
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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