A clinical trials manual from the Duke Clinical Research Institute : lessons from a horse named Jim / Margaret B. Liu and Kate Davis.

STN.: 273/47 No.:01 FY:2072/73 Rev. ed. of: Lessons from a horse named Jim / by Margaret B. Liu and Kate Davis. c2001.

Includes bibliographical references and index.

Lessons from a horse named Jim and other events in history affecting the regulation of clinical research -- The process : developing new drugs, biologics, and devices -- Good clinical practice and the regulations -- Informed consent and the regulations -- Institutional review boards -- Adverse events and unanticipated problems involving risks to subjects and others -- Monitoring, audits, and inspections -- The principal investigator, the clinical research coordinator, and the study site -- The protocol -- Study feasibility : reviewing a specific protocol -- Study activities -- Study documents/essential documents -- Management of study drugs, biologics, and devices -- Managing clinical trial data -- Global health and international trials.