A Practical Guide to Managing Clinical Trials

A comprehensive guide to conducting clinical trials. This textbook is designed clinical research management academic programs and for individuals working in research site operations. This user-friendly reference guides the reader through each step of the clinical trial process from site selection, to site set-up, subject recruitment, study visits, and study close-out. Topics include staff roles and responsibilities, budget and contract review and management, subject study visits, data management, event reporting, research ethics, audits and inspections, consenting process, IRB oversight, FDA regulations and GCPs. 

Pfeiffer, JoAnn & Wells, Cris. (2016) CRC Press. ISBN: 978-1-138-19650-6