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A Practical Guide to Managing Clinical Trials is a basic, comprehensive guide to conducting clinical trials. Designed 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 to study close-out. Topics include staff roles/responsibilities/training, budget and contract review and management, subject study visits, data and document management, event reporting, research ethics, audits and inspections, consent processes, IRB, FDA regulations, and good clinical practices. Each chapter concludes with a review of key points and knowledge application.
Unique to this book is “A View from India,” a chapter-by-chapter comparison of clinical trial practices in India versus the U.S. Throughout the book and in Chapter 10, readers will glimpse some of the challenges and opportunities in the emerging and growing market of Indian clinical trials.
Features of A Practical Guide to Managing Clinical Trials PDF
Here are important features of this book:
- Step-by-step process guides to conducting clinical trials
- Practical references for site evaluations, managing budgets and contracts, determining study feasibility and performing various site activities
- Examples and scenarios related to current practices in the industry
- Resources, references, tools, templates and regulatory/ethical references
Dr. JoAnn Pfeiffer (Author)
Dr. Pfeiffer earned her doctorate and master’s in Regulatory Science from the University of Southern California International Regulatory Science Program. Recent research include current practices of US investigators in the management of clinical trial agreements. She has an extensive background in clinical trial operations. Her expertise and education also include: regulatory compliance, CFRs, GCPs, HIPAA, budget management, contract management, site audits, performance management, SOPs, protocol, consents, IRB submissions, and regulatory reporting
Table of Contents
Below is the complete table of contents offered inside A Practical Guide to Managing Clinical Trials PDF:
Chapter 1 Rules, Roles, and Responsibilities
Chapter 2 Products, Protocols, and Pretrial Preparation
Chapter 3 Sponsor, Site, and Study Start-Up
Chapter 4 Enticement, Enrollment, and Engagement: The Informed Consent Process
Chapter 5 From Enrollment to Final Visit
Chapter 6 Collaborating for Compliance and Quality Data—Monitoring and Audits
Chapter 7 Building Budgets
Chapter 8 Contracts, Clauses, and Closing the Dea
Chapter 9 U.S. Clinical Trials—Additional Topics
Chapter 10 Clinical Research and India.
Below are the technical specifications of A Practical Guide to Managing Clinical Trials PDF:
- Book Name: A Practical Guide to Managing Clinical Trials
- Edition : 1st Edition | | ISBN : 1138196509
- Author Name: JoAnn Pfeiffer, Cris Wells
- Category: Medical
- Format / Pages : PDF – 276 Pages
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A Practical Guide to Managing Clinical Trials PDF Free Download
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