By Margaret B. Liu, Kate Davis(auth.)
Chapter 1 classes from a Horse Named Jim and different occasions in background Affecting the rules of medical learn (pages 1–11):
Chapter 2 the method: constructing New medications, Biologics, and units (pages 13–48):
Chapter three sturdy medical perform and the laws (pages 49–72):
Chapter four trained Consent and the laws (pages 73–100):
Chapter five Institutional assessment forums (pages 101–121):
Chapter 6 antagonistic occasions and Unanticipated difficulties related to dangers to matters or Others (pages 123–139):
Chapter 7 tracking, Audits, and Inspections (pages 141–162):
Chapter eight The valuable Investigator, the scientific learn Coordinator, and the learn website (pages 163–176):
Chapter nine The Protocol (pages 177–198):
Chapter 10 research Feasibility: Reviewing a selected Protocol (pages 199–212):
Chapter eleven research actions (pages 213–244):
Chapter 12 research Documents/Essential records (pages 245–269):
Chapter thirteen administration of research medicinal drugs, Biologics, and units (pages 271–279):
Chapter 14 coping with scientific Trial info (pages 281–311):
Chapter 15 international health and wellbeing and foreign Trials (pages 313–324):
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