Physician Investigator Handbook

GCP Tools and Techniques, Second Edition

Deborah Rosenbaum, Fred Smith

$131

Paperback

Not in-store but you can order this
How long will it take?

Availability Information

We source books from suppliers in Australia and overseas. For books we don't currently have in stock, the time it takes to get them from our suppliers can vary widely - from a few days to a few months - so we check each book with each supplier to determine the expected time it will take to be supplied to us.

We then advise you accordingly. If the time taken to get any book is too long for you, you can let us know and we will cancel or adjust your order, and refund as required.

To find out the anticipated arrival time for specific items prior to ordering, please contact us by phone or email:

Phone +61 2 9264 3111, or 1800 4 BOOKS (1800 4 26657) if outside Sydney:
option 1 Abbey's Bookshop (Crime, History, Science, Kids & more) • info@abbeys.com.au
option 2 Language Book Centre (ESL & Foreign Languages) • language@abbeys.com.au
option 3 Galaxy Bookshop (Sci-fi, Fantasy, Romance, Graphic Novels) • sf@galaxybooks.com.au

QTY:

English

CRC Press
10 October 2019

Clinical trials

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 close-out of a trial is in this book. The chapters 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.

By: Deborah Rosenbaum, Fred Smith
Imprint: CRC Press
Country of Publication: United Kingdom
Dimensions: Height: 276mm, Width: 219mm,
Weight: 902g
ISBN: 9780367396428
ISBN 10: 0367396424
Pages: 482
Publication Date: 10 October 2019
Audience: Professional and scholarly , Undergraduate
Format: Paperback
Publisher's Status: Active

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.

Rosenbaum, Deborah; Smith, Fred