2019 TheComprehensiveGuideToClinical
- (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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- http://scholar.google.com/scholar?q=%222019%22+The+Comprehensive+Guide+To+Clinical+Research%3A+A+Practical+Handbook+For+Gaining+Insight+Into+The+Clinical+Research+Industry
- https://read.amazon.com/?asin=B07R1T2GZH
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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)
- SOPs
- 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
References
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| Author | volume | Date Value | title | type | journal | titleUrl | doi | note | year | |
|---|---|---|---|---|---|---|---|---|---|---|
| 2019 TheComprehensiveGuideToClinical | Chris Sauber Dan Sfera | The Comprehensive Guide To Clinical Research: A Practical Handbook For Gaining Insight Into The Clinical Research Industry | 2019 |