{"product_id":"2940011814839","title":"Good Clinical Practice: Pharmaceutical, Biologics, and Medical Device Regulations and Guidance Documents Concise Reference; Volume 1, Regulations","description":"Topics covered include:\u003cbr\u003e\u003cbr\u003e* A brief description of the history and development of clinical research and good clinical practice\u003cbr\u003e* Title 21 CFR Parts 11, 50, 54, 56, 58, 210, 312, 314, 320, 511, 514, 601, 812, and 814 \u003cbr\u003e* FDA and ICH GCP Standards for Clinical Research \u003cbr\u003e* Form FDA 1572-Statement of Investigator \u003cbr\u003e* Informed Consent \u003cbr\u003e* Patient Recruitment \u003cbr\u003e* State Standards and GCP \u003cbr\u003e* Source Data\/Documentation \u003cbr\u003e* Investigator\/Site Requirements \u003cbr\u003e* Clinical Monitoring \u003cbr\u003e* Clinical Study Safety Reporting\u003cbr\u003e* Clinical Trial Protocols\/Protocol Changes\/Protocol Violations \u003cbr\u003e* Institutional Review Boards \u003cbr\u003e* Quality Assurance Activities\/Study Auditing\/FDA Inspections\u003cbr\u003e * Investigational Drug Accountability, Administration, and Labeling","brand":"PharmaLogika","offers":[{"title":"Default Title","offer_id":47152294396144,"sku":"2940011814839","price":36.99,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0737\/7593\/9824\/files\/2940011814839_p0.jpg?v=1763550031","url":"https:\/\/shop-qa.barnesandnoble.com\/products\/2940011814839","provider":"Barnes \u0026 Noble (DEV)","version":"1.0","type":"link"}