{"product_id":"good-clinical-practice-pharmaceutical-biologics-and-medical-device-regulations-and-guidance-documents-concise-reference-volume-1-regulations-9780982147672","title":"Good Clinical Practice: Pharmaceutical, Biologics, and Medical Device Regulations and Guidance Documents Concise Reference; Volume 1, Regulations","description":"\u003cp\u003e • Author(s): Mindy J. Allport-Settle\u003cbr\u003e • Publisher: Pharmalogika\u003cbr\u003e • Publisher Imprint: Pharmalogika\u003cbr\u003e • BISAC: Clinical Medicine\u003c\/p\u003e\u003cp\u003e\u003c\/p\u003e\u003cp\u003eTopics covered include: * A brief description of the history and development of clinical research and good clinical practice * Title 21 CFR Parts 11, 50, 54, 56, 58, 210, 312, 314, 320, 511, 514, 601, 812, and 814 * FDA and ICH GCP Standards for Clinical Research * Form FDA 1572-Statement of Investigator * Informed Consent * Patient Recruitment * State Standards and GCP * Source Data\/Documentation * Investigator\/Site Requirements * Clinical Monitoring * Clinical Study Safety Reporting * Clinical Trial Protocols\/Protocol Changes\/Protocol Violations * Institutional Review Boards * Quality Assurance Activities\/Study Auditing\/FDA Inspections * Investigational Drug Accountability, Administration, and Labeling\u003c\/p\u003e","brand":"Pharmalogika","offers":[{"title":"Paperback","offer_id":45508704960663,"sku":"9780982147672","price":4228.0,"currency_code":"INR","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0666\/3471\/1191\/files\/9780982147672.webp?v=1767459742","url":"https:\/\/atlanticbooks.com\/products\/good-clinical-practice-pharmaceutical-biologics-and-medical-device-regulations-and-guidance-documents-concise-reference-volume-1-regulations-9780982147672","provider":"Atlantic Books","version":"1.0","type":"link"}