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.

Klappentext

A comprehensive reference and guide on the implementation of good clinical practice (GCP) in clinical trials

Good clinical practice (GCP) is the ethical and regulatory framework for conducting biomedical clinical studies in humans. GCP has been implemented in the US, the EU, Japan, and many other global regions and nationsclinical research professionals are required to fully integrate GCP in the planning, execution, monitoring, analysis, and reporting of clinical trials. Written by authors with decades of experience in the field, The Fundamentals of Clinical Research: A Universal Guide for Implementing Good Clinical Practice provides expert guidance on the regulatory, scientific, administrative, business, and ethical aspects of the application of GCP in clinical trials.

Reflecting current ICH-GCP guidelines, this up-to-date volume describes drug development in the regulatory environment, defines the roles and responsibilities of the different players involved, discusses quality systems and procedures in clinical research, and more. Detailed chapters address key topics such as study design for GCP, trial management, resourcing and outsourcing, risk assessment, human subject protection, data collection, and regulatory authority inspection. The text offers a range of pedagogical features such as chapter objectives and content summaries, and includes self-review questions at the end of each chapter. Covering the various disciplines, stages, and best practices of clinical research, this authoritative guide:

• Describes how to successfully implement clinical trials that meet research, regulatory, GCP, and ethical objectives
• Presents a thorough overview of the clinical trial industry and the fundamentals of clinical research
• Covers the history of GCP, the present-day GCP framework, GCP for the individual clinical trial, GCP in the context of drug development, and improving the quality and outcomes of clinical trials
• Includes plates that visually summarize the content and allow readers to cross-reference details in relevant chapters
• Offers a companion website containing supplemental teaching and learning resources

The Fundamentals of Clinical Research: A Universal Guide for Implementing Good Clinical Practice is a must-have reference for clinical research scientists and managers, biostatisticians, pharmacologists, clinical research associates, data management personnel, clinical coordinators, and regulatory personnel involved in clinical trials of drugs, biologics, and medical devices. It also serves as an ideal textbook for educational programs covering clinical trial design, clinical research, and regulatory affairs.

Inhalt

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
P. Michael Dubinsky

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
Karen A. Henry

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
P. Michael Dubinsky

18 The Clinical Trial Protocol and Amendments 211
Karen A. Henry

19 Informed Consent and Other Human Subject Protection 239
Karen A. Henry

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
P. Michael Dubinsky

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