Deborah Rosenbaum, Fred Smith

Physician Investigator Handbook (eBook, ePUB)

GCP Tools and Techniques, Second Edition

• Format: ePub

Produktbeschreibung

A comprehensive guide for physicians conducting clinical research, this second edition addresses a broader research perspective. It includes information on the implications of the ICH Guidelines, current FDA regulations, and an Internet address directory. Everything the clinical trial manager, planner, monitor, and investigator need to know about t

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Produktdetails

• Verlag: Taylor & Francis eBooks
• Seitenzahl: 482
• Erscheinungstermin: 1. Januar 2002
• Englisch
• ISBN-13: 9781040204870
• Artikelnr.: 72583929

Autorenporträt

Rosenbaum, Deborah; Smith, Fred

Inhaltsangabe

Overview and Elements of Clinical Research. The Physician as Investigator.
Professional Interactions. FDA Regulations and Good Clinical Practices
Guidelines. Investigational Agent Management. Designing a Study and
Protocol Development. The Informed Consent Process. Conducting the Study.
Monitoring of Clinical Trials. Interactions with the Study Subjects.
Adverse Events and Drug Safety. Data Management. The Study Results. Audits
of Clinical Research Sites.