The Fundamentals of Clinical Research A Universal Guide for Implementing Good Clinical Practice

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.

• Describes the design of quality into the clinical trial planning
• Has end-of-chapter questions and answers to check learning and comprehension
• Includes charts that visually summarize the content and allow readers to cross-reference details in relevant chapters
• Offers a companion website containing supplemental training resources

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 3
P. Michael Dubinsky

Part II Drug Development in the Regulatory Environment 11

2 Regulatory Environment 13
P. Michael Dubinsky

3 GCP in Context 25
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4 The Intersection of GCP and Regulation 31
P. Michael Dubinsky

5 Regulatory Affairs 39
P. Michael Dubinsky

Part III Good Clinical Practice 47

6 GCP Definition and Principles 49
Karen A. Henry

7 Players Roles and Responsibilities Overview 59
Karen A. Henry

8 IRB/IEC Roles and Responsibilities 67
P. Michael Dubinsky

9 Investigator and Sponsor Roles and Responsibilities 73
Karen A. Henry

10 The Research Volunteer 85
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11 Regulatory Authority – Roles and Responsibilities 93
P. Michael Dubinsky

Part IV Individual Clinical Trial 101

12 Individual Clinical Trial Overview 103
Karen A. Henry

13 Risk Assessment and Quality Management 129
P. Michael Dubinsky

14 Trial Management; Start-up, On-Study, and Close-Out 135
Karen A. Henry

15 Trial Resourcing and Outsourcing 173
Karen A. Henry

16 The Investigator’s Brochure 183
Karen A. Henry

17 The Investigational Product (Clinical Supplies) 201
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18 The Clinical Trial Protocol and Amendments 211
Karen A. Henry

19 Informed Consent and Other Human Subject Protection 239
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20 Data Collection and Data Management 265
Karen A. Henry

21 Safety Monitoring and Reporting 285
Karen A. Henry

22 Monitoring Overview 301
Karen A. Henry

23 Investigator/Institution Selection 323
Karen A. Henry

24 Investigator/Institution Initiation 343
Karen A. Henry

25 Investigator/Institution Interim Monitoring 363
Karen A. Henry

26 Investigator/Institution Close-out 381
Karen A. Henry

27 Study Design and Data Analysis 401
Karen A. Henry

28 The Clinical Study Report 415
Karen A. Henry

29 Essential Documents 435
Karen A. Henry

Part V Quality in Clinical Trials 451

30 Quality Systems in Clinical Research 453
P. Michael Dubinsky

31 Quality Responsibilities 463
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32 Standard Operating Procedures 475
P. Michael Dubinsky

33 Quality Assurance Components 489
P. Michael Dubinsky

34 Regulatory Authority Inspections 497
P. Michael Dubinsky

References for all Chapters 503

Index 505

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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.