{"product_id":"the-fundamentals-of-clinical-research-isbn-9781118949597","title":"The Fundamentals of Clinical Research","description":"\u003cp\u003eThis 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.\u003c\/p\u003e \u003cul\u003e \u003cli\u003eDescribes the design of quality into the clinical trial planning\u003c\/li\u003e \u003cli\u003eHas end-of-chapter questions and answers to check learning and comprehension\u003c\/li\u003e \u003cli\u003eIncludes charts that visually summarize the content and allow readers to cross-reference details in relevant chapters\u003c\/li\u003e \u003cli\u003eOffers a companion website containing supplemental training resources\u003c\/li\u003e \u003c\/ul\u003e \u003cp\u003ePreface viii\u003c\/p\u003e \u003cp\u003eAbout the Authors xi\u003c\/p\u003e \u003cp\u003eAbout the Companion Website xii\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePart I Good Clinical Practice History \u003c\/b\u003e\u003cb\u003e1\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e1 History 3\u003cbr\u003e\u003ci\u003eP. Michael Dubinsky\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePart II Drug Development in the Regulatory Environment \u003c\/b\u003e\u003cb\u003e11\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e2 Regulatory Environment 13\u003cbr\u003e\u003ci\u003eP. Michael Dubinsky\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e3 GCP in Context 25\u003cbr\u003e\u003ci\u003eP. Michael Dubinsky\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e4 The Intersection of GCP and Regulation 31\u003cbr\u003e\u003ci\u003eP. Michael Dubinsky\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e5 Regulatory Affairs 39\u003cbr\u003e\u003ci\u003eP. Michael Dubinsky\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePart III Good Clinical Practice \u003c\/b\u003e\u003cb\u003e47\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e6 GCP Definition and Principles 49\u003cbr\u003e\u003ci\u003eKaren A. Henry\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e7 Players Roles and Responsibilities Overview 59\u003cbr\u003e\u003ci\u003eKaren A. Henry\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e8 IRB\/IEC Roles and Responsibilities 67\u003cbr\u003e\u003ci\u003eP. Michael Dubinsky\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e9 Investigator and Sponsor Roles and Responsibilities 73\u003cbr\u003e\u003ci\u003eKaren A. Henry\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e10 The Research Volunteer 85\u003cbr\u003e\u003ci\u003eKaren A. Henry\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e11 Regulatory Authority – Roles and Responsibilities 93\u003cbr\u003e\u003ci\u003eP. Michael Dubinsky\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePart IV Individual Clinical Trial \u003c\/b\u003e\u003cb\u003e101\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e12 Individual Clinical Trial Overview 103\u003cbr\u003e\u003ci\u003eKaren A. Henry\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e13 Risk Assessment and Quality Management 129\u003cbr\u003e\u003ci\u003eP. Michael Dubinsky\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e14 Trial Management; Start-up, On-Study, and Close-Out 135\u003cbr\u003e\u003ci\u003eKaren A. Henry\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e15 Trial Resourcing and Outsourcing 173\u003cbr\u003e\u003ci\u003eKaren A. Henry\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e16 The Investigator’s Brochure 183\u003cbr\u003e\u003ci\u003eKaren A. Henry\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e17 The Investigational Product (Clinical Supplies) 201\u003cbr\u003e\u003ci\u003eP. Michael Dubinsky\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e18 The Clinical Trial Protocol and Amendments 211\u003cbr\u003e\u003ci\u003eKaren A. Henry\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e19 Informed Consent and Other Human Subject Protection 239\u003cbr\u003e\u003ci\u003eKaren A. Henry\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e20 Data Collection and Data Management 265\u003cbr\u003e\u003ci\u003eKaren A. Henry\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e21 Safety Monitoring and Reporting 285\u003cbr\u003e\u003ci\u003eKaren A. Henry\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e22 Monitoring Overview 301\u003cbr\u003e\u003ci\u003eKaren A. Henry\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e23 Investigator\/Institution Selection 323\u003cbr\u003e\u003ci\u003eKaren A. Henry\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e24 Investigator\/Institution Initiation 343\u003cbr\u003e\u003ci\u003eKaren A. Henry\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e25 Investigator\/Institution Interim Monitoring 363\u003cbr\u003e\u003ci\u003eKaren A. Henry\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e26 Investigator\/Institution Close-out 381\u003cbr\u003e\u003ci\u003eKaren A. Henry\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e27 Study Design and Data Analysis 401\u003cbr\u003e\u003ci\u003eKaren A. Henry\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e28 The Clinical Study Report 415\u003cbr\u003e\u003ci\u003eKaren A. Henry\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e29 Essential Documents 435\u003cbr\u003e\u003ci\u003eKaren A. Henry\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e\u003cb\u003ePart V Quality in Clinical Trials \u003c\/b\u003e\u003cb\u003e451\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003e30 Quality Systems in Clinical Research 453\u003cbr\u003e\u003ci\u003eP. Michael Dubinsky\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e31 Quality Responsibilities 463\u003cbr\u003e\u003ci\u003eP. Michael Dubinsky\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e32 Standard Operating Procedures 475\u003cbr\u003e\u003ci\u003eP. Michael Dubinsky\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e33 Quality Assurance Components 489\u003cbr\u003e\u003ci\u003eP. Michael Dubinsky\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003e34 Regulatory Authority Inspections 497\u003cbr\u003e\u003ci\u003eP. Michael Dubinsky\u003c\/i\u003e\u003c\/p\u003e \u003cp\u003eReferences for all Chapters 503\u003c\/p\u003e \u003cp\u003eIndex 509\u003c\/p\u003e \u003cp\u003e\u003cb\u003eP. Michael Dubinsky \u003c\/b\u003ehas 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.\u003c\/p\u003e \u003cp\u003e\u003cb\u003eKaren A. Henry\u003c\/b\u003e 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.   \u003c\/p\u003e\u003cp\u003e\u003cb\u003eA comprehensive reference and guide on the implementation of good clinical practice (GCP) in clinical trials\u003c\/b\u003e\u003c\/p\u003e \u003cp\u003eGood 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,\u003ci\u003e The Fundamentals of Clinical Research: A Universal Guide for Implementing Good Clinical Practice\u003c\/i\u003e provides expert guidance on the regulatory, scientific, administrative, business, and ethical aspects of the application of GCP in clinical trials. \u003c\/p\u003e\u003cp\u003eReflecting 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: \u003c\/p\u003e\u003cul\u003e\n\u003cli\u003eDescribes how to successfully implement clinical trials that meet research, regulatory, GCP, and ethical objectives \u003c\/li\u003e \u003cli\u003ePresents a thorough overview of the clinical trial industry and the fundamentals of clinical research\u003c\/li\u003e \u003cli\u003eCovers 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\u003c\/li\u003e \u003cli\u003eIncludes plates that visually summarize the content and allow readers to cross-reference details in relevant chapters\u003c\/li\u003e \u003cli\u003eOffers a companion website containing supplemental teaching and learning resources\u003c\/li\u003e\n\u003c\/ul\u003e \u003cp\u003e\u003ci\u003eThe Fundamentals of Clinical Research: A Universal Guide for Implementing Good Clinical Practice\u003c\/i\u003e 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.\u003c\/p\u003e","brand":"Wiley","offers":[{"title":"Default Title","offer_id":47990233301221,"sku":"NP9781118949597","price":199.95,"currency_code":"USD","in_stock":false}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/1842\/7735\/files\/9781118949597.jpg?v=1761787009","url":"https:\/\/k12savings.com\/es\/products\/the-fundamentals-of-clinical-research-isbn-9781118949597","provider":"K12savings","version":"1.0","type":"link"}