{"product_id":"the-fundamentals-of-clinical-research-9781118949597","title":"The Fundamentals of Clinical Research","description":"\u003cb\u003eBook Synopsis\u003c\/b\u003e\u003cbr\u003e\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\u003cbr\u003e\u003cbr\u003e\u003cb\u003eTable of Contents\u003c\/b\u003e\u003cbr\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","brand":"John Wiley \u0026 Sons Inc","offers":[{"title":"Default Title","offer_id":49989969248599,"sku":"9781118949597","price":138.56,"currency_code":"GBP","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0817\/1739\/5799\/files\/9781118949597.jpg?v=1739542850","url":"https:\/\/bookcurl.com\/products\/the-fundamentals-of-clinical-research-9781118949597","provider":"Book Curl","version":"1.0","type":"link"}