{"product_id":"good-clinical-practice-mindy-j-allport-settle-9780982147672","title":"Good Clinical Practice: Pharmaceutical, Biologics, and Medical Device Regulations and Guidance Documents Concise Reference; Volume 1, Regulati","description":"Topics 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\u003cbr\u003e\u003cbr\u003e\u003cb\u003eAuthor:\u003c\/b\u003e Mindy J. Allport-Settle\u003cbr\u003e\u003cb\u003eISBN-10:\u003c\/b\u003e 0982147678\u003cbr\u003e\u003cb\u003eISBN-13:\u003c\/b\u003e 9780982147672\u003cbr\u003e\u003cb\u003ePublisher:\u003c\/b\u003e Pharmalogika\u003cbr\u003e\u003cb\u003eLanguage:\u003c\/b\u003e English\u003cbr\u003e\u003cb\u003ePublished:\u003c\/b\u003e 08\/26\/2010\u003cbr\u003e\u003cb\u003ePages:\u003c\/b\u003e 712\u003cbr\u003e\u003cb\u003eFormat:\u003c\/b\u003e Paperback\u003cbr\u003e\u003cb\u003eWeight:\u003c\/b\u003e 2.06lbs\u003cbr\u003e\u003cb\u003eSize:\u003c\/b\u003e 9.00h x 6.00w x 1.42d","brand":"Mindy J. Allport-Settle","offers":[{"title":"Paperback","offer_id":43926982557951,"sku":"9780982147672","price":46.99,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0662\/2982\/9887\/products\/img_dcd31be4-c790-448b-bc72-07b349cac701.jpg?v=1681086124","url":"https:\/\/www.whiterainbookhouse.com\/products\/good-clinical-practice-mindy-j-allport-settle-9780982147672","provider":"WR Book House","version":"1.0","type":"link"}