Physician Investigator Handbook: Gcp Tools and Techniques, Second Edition

ISBN-13: 9780367396428 / Angielski / Miękka / 2019 / 482 str.

Deborah Rosenbaum; Fred Smith

Opis

Presenting a broad research perspective, this second edition of a bestseller is a comprehensive guide for physicians conducting clinical research. 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 close-out of a trial is in this book. The authors address the elements of clinical research, professional interactions, FDA regulations and good clinical practices guidelines, investigational agent management, designing a study and protocol development, conducting the study, and more.

Spis treści

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.

O autorze

Rosenbaum, Deborah; Smith, Fred