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

Edition Second edition Published Chichester, West Sussex, UK ; Hoboken, NJ : Wiley-Blackwell, 2010

Online access available from: Wiley Online Books    View Resource Record

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Description 1 online resource (xviii, 406 pages) : illustrations Series Wiley SCELC e-books Contents 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 Summary As the number of clinical trials continues to grow, there is an increasing need for education and training in the field. The clinical research climate is less forgiving of errors and oversights and therefore requires more knowledge of regulations and requirements. This brand new edition details new laws and regulations in protecting children participating in clinical trials and how a new focus on privacy of individual health information in the United States has changed how medical records are handled.: Includes a manual for investigators, research nurses and study coordinators with minimal exp Notes Revised edition of: Lessons from a horse named Jim / by Margaret B. Liu and Kate Davis. c2001 Bibliography Includes bibliographical references and index Notes Print version record Subject Clinical Trials as Topic -- legislation & jurisprudence. Clinical Trials as Topic -- ethics. Device Approval. Clinical trials -- Handbooks, manuals, etc. Drug Approval. Drugs -- Testing -- Handbooks, manuals, etc. SUBJECT United States. https://id.nlm.nih.gov/mesh/D014481 Genre/Form Handbooks and manuals. Handbooks and manuals. Form Electronic book Author Davis, Kate (Kate G.) Liu, Margaret B. Lessons from a horse named Jim Duke Clinical Research Institute. ISBN 1444315218 1444315226 (electronic bk.) 9781444315219 9781444315226 (electronic bk.) (print) (print)

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