Study Site Training Series (2018): Volume 2: FDA Clinical Research Regulations and GCPs: The Essentials

Barnett International Publication
$99.00

 SSV18 Vol 2

Study Site Training Series (2018): Volume 2 - FDA Clinical Research Regulations and GCPs: The Essentials

This volume describes the “rules” and “guidelines” developed by regulatory agencies designed to regulate the conduct of clinical research, emphasizing those requirements that most directly impact investigative site teams. This volume describes the “rules” and “guidelines” developed by regulatory agencies designed to regulate the conduct of clinical research, emphasizing those requirements that most directly impact investigative site teams.

Each volume can be purchased separately or the full 6-volume series can be purchased for $499. For details on the individual volumes and to order, click on the individual volume listed at the bottom of the page. Publications in this set include:

  • Volume 1: The Clinical Study Site Team: Roles and Responsibilities
  • Volume 2: FDA Clinical Research Regulations and GCPs: The Essentials
  • Volume 3: IRBs/IECs and Informed Consent: Protecting the Rights of Human Subjects
  • Volume 4: Sponsor Visits and Regulatory Audits: What You Need to Know
  • Volume 5: Your Role in Reporting Adverse Experiences
  • Volume 6: Understanding, Evaluating, and Implementing Clinical Protocols

Reader Testimonial:

“A common sense, practical introduction to the roles of the study coordinator and investigator. It is excellent preparation for anyone at a research site — or at a study sponsor or CRO — who wants to understand how studies are conducted at sites.”
- Norman M. Goldfarb, Managing Director, First Clinical Research LLC

 

Check out all of the volumes in the series:

Volume 1  Volume 3  Volume 5 Volume 6