The Fundamentals of Clinical Research

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

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