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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
Table des matières
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 509
A propos de l'auteur
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.
