2019 TheComprehensiveGuideToClinical

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  • (Sauber & Sfera, 2019) ⇒ Chris Sauber, and Dan Sfera. (2019). “The Comprehensive Guide To Clinical Research: A Practical Handbook For Gaining Insight Into The Clinical Research Industry.” Amazon Digital Services LLC - KDP Print US. ISBN:9781090349521

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Book Overview

Condensing the most important topics in all of clinical research in an easy to understand presentation. The 20 percent of what you need to know in order to be 80 percent proficient!

The authors who have operated various levels of businesses in the clinical research industry since 2005 believe that more practical information pertaining to clinical research needs to be accessible to individuals who are new to the industry or are curious about entering the rewarding world of clinical trials.

This book reads in an easy to understand style and is based on proven methods the authors have developed to train their own employees and students of their various clinical research academies throughout the years. Picking this up and absorbing the information will allow anyone to gain much better insight into the complicated dynamics of clinical research. This practical roadmap is all you will need to get started on your clinical trial journey!

In this book you will learn about:

  • Regulations and the history as well as evolution of GCP.
  • Clinical Research Site Operations
  • Monitoring Dynamics and Typical Monitoring Vists
  • CRO Activities
  • Sponsor Level Dynamics
  • Industry Vendors
  • Common Career Opportunities and Employment Roadmaps

Table of Contents

Chapter 1: A Bird’s Eye View of the Clinical Research Landscape

Chapter 2: Phases and Design of Clinical Trials

Chapter 3: Regulations

Chapter 4: Site Level Dynamics

Finding a PI
Office Layout and Necessary Equipment
Getting Studies
Two Types of Documents for Every Study
Source Documents
Regulatory Documents
Serious Adverse Events (SAEs) and Suspected Unexpected Serious Adverse Reactions (SUSARs)
Study Staff and Training
Quality Assurance

Chapter 5: Monitoring

Monitoring Visits
Site Selection Visits
Site Initiation Visits
Interim Monitoring Visits
Close Out Visits
Booster Visits
Pre-Audit Visits

Chapter 6: CRO/Sponsor Dynamics

Chapter 7: Jobs in the Research Industry

Chapter 8: Common Vendors, Useful Certification and Training Links Conclusion



 AuthorvolumeDate ValuetitletypejournaltitleUrldoinoteyear
2019 TheComprehensiveGuideToClinicalChris Sauber
Dan Sfera
The Comprehensive Guide To Clinical Research: A Practical Handbook For Gaining Insight Into The Clinical Research Industry2019