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What is included with this book?
This book focuses on the practical application of good clinical practice (GCP) fundamentals and provides insight into roles and responsibilities included in planning, executing, and analyzing clinical trials. The authors describe the design of quality into clinical trial planning and the application of regulatory, scientific, administrative, business, and ethical considerations.
P. Michael Dubinsky has more than forty years of experience in the field of GxP quality and compliance in government and industry. He has worked with the FDA and as a regulatory consultant for private corporations. He was also an Instructor in the areas of clinical trial compliance, regulatory audits, and quality at the University of California Berkeley Extension Programs.
Karen A. Henry has worked as a clinical research professional since 1990. She has expertise in regulatory medical writing, standards and processes, trial management and monitoring, biostatistics, and data management. She is also a Lead Instructor for the Certificate Program in Clinical Research Conduct Management at the University of California Berkeley Extension Programs.
Preface viii
About the Authors xi
About the Companion Website xii
Part I Good Clinical Practice History 1
1 History 3P. Michael Dubinsky
Part II Drug Development in the Regulatory Environment 11
2 Regulatory Environment 13P. Michael Dubinsky
3 GCP in Context 25P. Michael Dubinsky
4 The Intersection of GCP and Regulation 31P. Michael Dubinsky
5 Regulatory Affairs 39P. Michael Dubinsky
Part III Good Clinical Practice 47
6 GCP Definition and Principles 49Karen A. Henry
7 Players Roles and Responsibilities Overview 59Karen A. Henry
8 IRB/IEC Roles and Responsibilities 67P. Michael Dubinsky
9 Investigator and Sponsor Roles and Responsibilities 73Karen A. Henry
10 The Research Volunteer 85Karen A. Henry
11 Regulatory Authority – Roles and Responsibilities 93P. Michael Dubinsky
Part IV Individual Clinical Trial 101
12 Individual Clinical Trial Overview 103Karen A. Henry
13 Risk Assessment and Quality Management 129P. Michael Dubinsky
14 Trial Management; Start-up, On-Study, and Close-Out 135Karen A. Henry
15 Trial Resourcing and Outsourcing 173Karen A. Henry
16 The Investigator’s Brochure 183Karen A. Henry
17 The Investigational Product (Clinical Supplies) 201P. Michael Dubinsky
18 The Clinical Trial Protocol and Amendments 211Karen A. Henry
19 Informed Consent and Other Human Subject Protection 239Karen A. Henry
20 Data Collection and Data Management 265Karen A. Henry
21 Safety Monitoring and Reporting 285Karen A. Henry
22 Monitoring Overview 301Karen A. Henry
23 Investigator/Institution Selection 323Karen A. Henry
24 Investigator/Institution Initiation 343Karen A. Henry
25 Investigator/Institution Interim Monitoring 363Karen A. Henry
26 Investigator/Institution Close-out 381Karen A. Henry
27 Study Design and Data Analysis 401Karen A. Henry
28 The Clinical Study Report 415Karen A. Henry
29 Essential Documents 435Karen A. Henry
Part V Quality in Clinical Trials 451
30 Quality Systems in Clinical Research 453P. Michael Dubinsky
31 Quality Responsibilities 463P. Michael Dubinsky
32 Standard Operating Procedures 475P. Michael Dubinsky
33 Quality Assurance Components 489P. Michael Dubinsky
34 Regulatory Authority Inspections 497P. Michael Dubinsky
References for all Chapters 503
Index 505
The New copy of this book will include any supplemental materials advertised. Please check the title of the book to determine if it should include any access cards, study guides, lab manuals, CDs, etc.
The Used, Rental and eBook copies of this book are not guaranteed to include any supplemental materials. Typically, only the book itself is included. This is true even if the title states it includes any access cards, study guides, lab manuals, CDs, etc.