{"product_id":"book-1c-2026-good-clinical-practice-regulations-in-the-us-the-eu-copy","title":"Book 1C:  2026 Good Clinical Practice Regulations in the US \u0026 the EU \u003cspan style=\"color: #b70202\"\u003e(With FDA\/ICH GCP E6(R3))\u003c\/span\u003e","description":"\u003cdiv id=\"tabs\"\u003e\n\u003cul\u003e\n\u003cli\u003e\u003ca href=\"#tabs-1\"\u003eDescription\u003c\/a\u003e\u003c\/li\u003e\n\u003cli\u003e\u003ca href=\"#tabs-2\"\u003eContents\u003c\/a\u003e\u003c\/li\u003e\n\u003cli\u003e\u003ca href=\"#tabs-3\"\u003eCover\u003c\/a\u003e\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cdiv id=\"tabs-1\"\u003e\n\u003cp class=\"bigblacktext\" align=\"left\"\u003e\u003cspan class=\"smallgray\"\u003eThis spiral-bound, 5\" x 7.5\" book consists of US FDA GCP regulations, including all of 21 CFR Part 314 (NDAs), ICH Guidelines,  the new EU Clinical Trials Regulation, as well as the EU GCP Directive and the repealed EU Clinical Trials Directive.\u003c\/span\u003e\u003c\/p\u003e\n\u003cp class=\"smallblack\" align=\"left\"\u003e\u003cspan style=\"color: #000099;\" color=\"#000099\"\u003eWho Uses this Book and How?\u003c\/span\u003e\u003cspan class=\"smallgray\"\u003e\u003cbr\u003e• Clinical Research staff, as job aids\u003cbr\u003e• Training departments, as training handouts\u003cbr\u003e• Human Resources, as part of new-employee orientation\u003cbr\u003e• Legal\/Regulatory\/QA staff, for company-wide distribution\u003cbr\u003e\u003c\/span\u003e\u003cbr\u003e\u003cspan style=\"color: #000099;\" color=\"#000099\"\u003eWhat's the Price?\u003c\/span\u003e\u003cbr\u003e\u003cspan class=\"smallgray\"\u003e• 1-99 copies:  $25.95             • 100-249 copies:  $24.95\u003cbr\u003e• 250-499 copies: $23.95          • 500+ copies:  $22.95\u003cbr\u003e\u003cspan style=\"color: #000099;\" color=\"#000099\"\u003e\u003cbr\u003e\u003c\/span\u003e\u003c\/span\u003e\u003cspan style=\"color: #000099;\" color=\"#000099\"\u003eCustom Cover Prices*?\u003c\/span\u003e\u003cspan class=\"smallgray\"\u003e\u003cbr\u003e• 1-24 copies:  unavailable             • 25-100 copies:  $2.00\/book\u003cbr\u003e• 100-249 copies: $1.00\/book        • 250+ copies:  No charge \u003cspan style=\"color: #000099;\" color=\"#000099\"\u003e\u003c\/span\u003e\u003cbr\u003e\u003cbr\u003e\u003cspan style=\"color: #000099;\" color=\"#000099\"\u003e* Based on quantities of a single book title\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cp style=\"text-align: center;\" class=\"smallblack\" align=\"left\"\u003e\u003cspan class=\"smallgray\"\u003eContents\u003c\/span\u003e\u003c\/p\u003e\n\u003c\/div\u003e\n\u003cdiv id=\"tabs-2\"\u003e\n\u003cp\u003e\u003cspan style=\"color: #ff2a00;\"\u003e \u003cstrong\u003e\u003cspan style=\"color: #000000;\"\u003e•  \u003c\/span\u003e\u003cspan style=\"color: rgb(204, 0, 0);\"\u003eEU Regulation No. 536\/2014\u003c\/span\u003e \u003cspan style=\"color: #000000;\"\u003eon clinical trials on medicinal products for human use, and repealing Directive 2001\/20\/EC\u003c\/span\u003e\u003c\/strong\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003e\u003cstrong\u003e•  CFR Title 21:  Food and Drugs\u003c\/strong\u003e\u003cspan style=\"color: #cc0000;\"\u003e \u003cstrong\u003e(Revised as of April 1, 2026)\u003c\/strong\u003e\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cp style=\"padding-left: 30px;\"\u003e\u003cspan\u003e\u003cspan\u003e\u003cspan\u003e\u003cstrong\u003e11\u003c\/strong\u003e    Electronic Records\/Electronic Signatures\u003c\/span\u003e\u003cspan style=\"color: #cc0000;\"\u003e \u003c\/span\u003e\u003c\/span\u003e\u003cbr\u003e\u003cstrong\u003e50\u003c\/strong\u003e    Protection of Human Subjects\u003cbr\u003e\u003cstrong\u003e54\u003c\/strong\u003e    Financial Disclosure\u003cbr\u003e\u003cstrong\u003e56\u003c\/strong\u003e    Institutional Review Boards \u003cbr\u003e\u003cstrong\u003e312\u003c\/strong\u003e  Investigational New Drug Application\u003cbr\u003e\u003cstrong\u003e314\u003c\/strong\u003e  Applications for FDA Approval to Market a New Drug \u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003e\u003cstrong\u003e•  Index to 21 CFR Parts 11, 50, 54, 56, 312, 314\u003c\/strong\u003e\u003cbr\u003e\u003cbr\u003e\u003cstrong\u003e•  ICH Guidelines\u003c\/strong\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cp style=\"padding-left: 30px;\"\u003e\u003cspan\u003e\u003cstrong\u003e\u003cspan style=\"color: rgb(204, 0, 3);\"\u003eE6(R3)  FDA\/ICH Good Clinical Practice Guidance (US Step 5 version) \u003c\/span\u003e\u003c\/strong\u003e\u003cbr\u003e\u003cstrong\u003eE2A\u003c\/strong\u003e   Clinical Safety Data Management: Definitions and Standards for Expedited Reporting\u003cbr\u003e\u003cstrong\u003eE8(R1)\u003c\/strong\u003e  General Considerations for Clinical Trials\u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan\u003e\u003cstrong\u003e•  European Directives on GCP \u003c\/strong\u003e\u003cstrong\u003e(2001 and 2005)\u003c\/strong\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003c\/div\u003e\n\u003cdiv id=\"tabs-3\"\u003e\n\u003cp\u003eClick \u003ca href=\"https:\/\/cdn.shopify.com\/s\/files\/1\/0856\/8592\/files\/book1c-fdae6r3coiled.pdf?v=1760474706\" rel=\"noopener\" target=\"_blank\"\u003ehere\u003c\/a\u003e to see an enlarged pdf cover\u003cbr\u003e\u003c\/p\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e","brand":"Clinical Research Resources, LLC","offers":[{"title":"Default Title","offer_id":44561131896947,"sku":null,"price":25.95,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0856\/8592\/files\/2026book1ccoiled.png?v=1775164259","url":"https:\/\/www.clinicalresearchresources.com\/products\/book-1c-2026-good-clinical-practice-regulations-in-the-us-the-eu-copy","provider":"Clinical Research Resources, LLC","version":"1.0","type":"link"}