Details

<p>Preface viii</p> <p>About the Authors xi</p> <p>About the Companion Website xii</p> <p><b>Part I Good Clinical Practice History </b><b>1</b></p> <p>1 History 3<br /><i>P. Michael Dubinsky</i></p> <p><b>Part II Drug Development in the Regulatory Environment </b><b>11</b></p> <p>2 Regulatory Environment 13<br /><i>P. Michael Dubinsky</i></p> <p>3 GCP in Context 25<br /><i>P. Michael Dubinsky</i></p> <p>4 The Intersection of GCP and Regulation 31<br /><i>P. Michael Dubinsky</i></p> <p>5 Regulatory Affairs 39<br /><i>P. Michael Dubinsky</i></p> <p><b>Part III Good Clinical Practice </b><b>47</b></p> <p>6 GCP Definition and Principles 49<br /><i>Karen A. Henry</i></p> <p>7 Players Roles and Responsibilities Overview 59<br /><i>Karen A. Henry</i></p> <p>8 IRB/IEC Roles and Responsibilities 67<br /><i>P. Michael Dubinsky</i></p> <p>9 Investigator and Sponsor Roles and Responsibilities 73<br /><i>Karen A. Henry</i></p> <p>10 The Research Volunteer 85<br /><i>Karen A. Henry</i></p> <p>11 Regulatory Authority – Roles and Responsibilities 93<br /><i>P. Michael Dubinsky</i></p> <p><b>Part IV Individual Clinical Trial </b><b>101</b></p> <p>12 Individual Clinical Trial Overview 103<br /><i>Karen A. Henry</i></p> <p>13 Risk Assessment and Quality Management 129<br /><i>P. Michael Dubinsky</i></p> <p>14 Trial Management; Start-up, On-Study, and Close-Out 135<br /><i>Karen A. Henry</i></p> <p>15 Trial Resourcing and Outsourcing 173<br /><i>Karen A. Henry</i></p> <p>16 The Investigator’s Brochure 183<br /><i>Karen A. Henry</i></p> <p>17 The Investigational Product (Clinical Supplies) 201<br /><i>P. Michael Dubinsky</i></p> <p>18 The Clinical Trial Protocol and Amendments 211<br /><i>Karen A. Henry</i></p> <p>19 Informed Consent and Other Human Subject Protection 239<br /><i>Karen A. Henry</i></p> <p>20 Data Collection and Data Management 265<br /><i>Karen A. Henry</i></p> <p>21 Safety Monitoring and Reporting 285<br /><i>Karen A. Henry</i></p> <p>22 Monitoring Overview 301<br /><i>Karen A. Henry</i></p> <p>23 Investigator/Institution Selection 323<br /><i>Karen A. Henry</i></p> <p>24 Investigator/Institution Initiation 343<br /><i>Karen A. Henry</i></p> <p>25 Investigator/Institution Interim Monitoring 363<br /><i>Karen A. Henry</i></p> <p>26 Investigator/Institution Close-out 381<br /><i>Karen A. Henry</i></p> <p>27 Study Design and Data Analysis 401<br /><i>Karen A. Henry</i></p> <p>28 The Clinical Study Report 415<br /><i>Karen A. Henry</i></p> <p>29 Essential Documents 435<br /><i>Karen A. Henry</i></p> <p><b>Part V Quality in Clinical Trials </b><b>451</b></p> <p>30 Quality Systems in Clinical Research 453<br /><i>P. Michael Dubinsky</i></p> <p>31 Quality Responsibilities 463<br /><i>P. Michael Dubinsky</i></p> <p>32 Standard Operating Procedures 475<br /><i>P. Michael Dubinsky</i></p> <p>33 Quality Assurance Components 489<br /><i>P. Michael Dubinsky</i></p> <p>34 Regulatory Authority Inspections 497<br /><i>P. Michael Dubinsky</i></p> <p>References for all Chapters 503</p> <p>Index 509</p>

<p><b>P. Michael Dubinsky </b>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.</p> <p><b>Karen A. Henry</b> 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.

<p><b>A comprehensive reference and guide on the implementation of good clinical practice (GCP) in clinical trials</b></p> <p>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 nations—clinical 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,<i> The Fundamentals of Clinical Research: A Universal Guide for Implementing Good Clinical Practice</i> provides expert guidance on the regulatory, scientific, administrative, business, and ethical aspects of the application of GCP in clinical trials. <p>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: <ul><li>Describes how to successfully implement clinical trials that meet research, regulatory, GCP, and ethical objectives </li> <li>Presents a thorough overview of the clinical trial industry and the fundamentals of clinical research</li> <li>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</li> <li>Includes plates that visually summarize the content and allow readers to cross-reference details in relevant chapters</li> <li>Offers a companion website containing supplemental teaching and learning resources</li></ul> <p><i>The Fundamentals of Clinical Research: A Universal Guide for Implementing Good Clinical Practice</i> 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.

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