1st Edition
Physician Investigator Handbook GCP Tools and Techniques, Second Edition
488 Pages
by
CRC Press
482 Pages
by
CRC Press
482 Pages
by
CRC Press
Also available as eBook on:
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 the design, establishment, monitoring, and... Read more
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.
Biography
Rosenbaum, Deborah; Smith, Fred
