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

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 viiiAbout the Authors xiAbout the Companion Website xiiPart I Good Clinical Practice History 11 History 3P. Michael DubinskyPart II Drug Development in the Regulatory Environment 112 Regulatory Environment 13P. Michael Dubinsky3 GCP in Context 25P. Michael Dubinsky4 The Intersection of GCP and Regulation 31P. Michael Dubinsky5 Regulatory Affairs 39P. Michael DubinskyPart III Good Clinical Practice 476 GCP Definition and Principles 49Karen A. Henry7 Players Roles and Responsibilities Overview 59Karen A. Henry8 IRB/IEC Roles and Responsibilities 67P. Michael Dubinsky9 Investigator and Sponsor Roles and Responsibilities 73Karen A. Henry10 The Research Volunteer 85Karen A. Henry11 Regulatory Authority - Roles and Responsibilities 93P. Michael DubinskyPart IV Individual Clinical Trial 10112 Individual Clinical Trial Overview 103Karen A. Henry13 Risk Assessment and Quality Management 129P. Michael Dubinsky14 Trial Management; Start-up, On-Study, and Close-Out 135Karen A. Henry15 Trial Resourcing and Outsourcing 173Karen A. Henry16 The Investigator's Brochure 183Karen A. Henry17 The Investigational Product (Clinical Supplies) 201P. Michael Dubinsky18 The Clinical Trial Protocol and Amendments 211Karen A. Henry19 Informed Consent and Other Human Subject Protection 239Karen A. Henry20 Data Collection and Data Management 265Karen A. Henry21 Safety Monitoring and Reporting 285Karen A. Henry22 Monitoring Overview 301Karen A. Henry23 Investigator/Institution Selection 323Karen A. Henry24 Investigator/Institution Initiation 343Karen A. Henry25 Investigator/Institution Interim Monitoring 363Karen A. Henry26 Investigator/Institution Close-out 381Karen A. Henry27 Study Design and Data Analysis 401Karen A. Henry28 The Clinical Study Report 415Karen A. Henry29 Essential Documents 435Karen A. HenryPart V Quality in Clinical Trials 45130 Quality Systems in Clinical Research 453P. Michael Dubinsky31 Quality Responsibilities 463P. Michael Dubinsky32 Standard Operating Procedures 475P. Michael Dubinsky33 Quality Assurance Components 489P. Michael Dubinsky34 Regulatory Authority Inspections 497P. Michael DubinskyReferences for all Chapters 503Index 509