{"product_id":"book-1b-2026-fda-good-clinical-practice-guide-copy","title":"Book 1B:  2026 FDA Good Clinical Practice Guide \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 align=\"left\"\u003e\u003cspan class=\"smallgray\"\u003e This spiral-bound, 5\" x 7.5\" book is a compilation of the FDA Good Clinical Practice regulations (21 CFR Parts 11, 50, 54, 56, and 312) and ICH Guidelines (E6, E2A, and E8), as well as the FDA Information Sheets and other guidance documents that govern the conduct of clinical trials for drug research.  Please note that this book does NOT contain the sections of 21 CFR Part 314 on New Drug Applications (NDAs).  21 CFR Part 314 is contained in its entirety in Book 1A, \u003cem\u003eSelected Regulations and Guidance for Drug Studies.\u003c\/em\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cp align=\"left\" class=\"smallblack\"\u003e\u003cspan color=\"#000099\" style=\"color: #000099;\"\u003eWho Uses this Book and How?\u003c\/span\u003e\u003cbr\u003e\u003cspan class=\"smallgray\"\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 color=\"#000099\" style=\"color: #000099;\"\u003eWhat's the Price?\u003c\/span\u003e\u003cbr\u003e\u003cspan class=\"smallgray\"\u003e• 1-99 copies:  $26.95             • 100-249 copies:  $25.95\u003cbr\u003e• 250-499 copies: $24.95          • 500+ copies:  $23.95\u003cbr\u003e\u003cbr\u003e\u003c\/span\u003e\u003cspan color=\"#000099\" style=\"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\u003cbr\u003e\u003cbr\u003e\u003cspan color=\"#000099\" style=\"color: #000099;\"\u003e* Based on quantities of a single book title\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003c\/div\u003e\n\u003cdiv id=\"tabs-2\"\u003e\n\u003cp align=\"left\" class=\"smallblack\"\u003e\u003cstrong\u003e•  Index to 21 CFR Parts 11, 50, 54, 56, 312, 314\u003c\/strong\u003e\u003cbr\u003e\u003cbr\u003e\u003cstrong\u003e•  CFR Title 21:  Food and Drugs\u003c\/strong\u003e\u003cspan color=\"#CC0000\" style=\"color: #cc0000;\"\u003e \u003cspan class=\"address\"\u003e (Revised as of April 2026)\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cp align=\"left\" class=\"smallblack\" style=\"padding-left: 30px;\"\u003e\u003cspan class=\"smallgray\"\u003e\u003cstrong\u003e11\u003c\/strong\u003e    Electronic Records\/Electronic Signatures \u003c\/span\u003e\u003cspan class=\"smallgray\"\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  Sections 314.80, 314.81:\u003c\/strong\u003e Post-Marketing Reporting\u003cbr\u003e\u003cstrong\u003eSection 314.126\u003c\/strong\u003e: Adequate and Well-Controlled Studies \u003c\/span\u003e\u003c\/p\u003e\n\u003cp align=\"left\" class=\"smallblack\"\u003e\u003cstrong\u003e•  Selected FDA Information Sheets, \u003c\/strong\u003eGuidance for IRBs, Clinical Investigators and Sponsors \u003c\/p\u003e\n\u003cul\u003e\n\u003cli\u003eFAQs on IRBs and informed consent\u003c\/li\u003e\n\u003cli\u003eCooperative Research\u003c\/li\u003e\n\u003cli\u003eNon-Local IRB Review\u003c\/li\u003e\n\u003cli\u003eSponsor-Investigator Relationship\u003c\/li\u003e\n\u003cli\u003eCharging for Investigational Products\u003c\/li\u003e\n\u003cli\u003eRecruiting Study Subjects\u003c\/li\u003e\n\u003cli\u003ePayment and Reimbursement to Research Subjects\u003c\/li\u003e\n\u003cli\u003eScreening Tests Prior to Enrollment\u003c\/li\u003e\n\u003cli\u003eOff-Label Use of Marketed Products\u003c\/li\u003e\n\u003cli\u003eEmergency Use of Investigational Products\u003c\/li\u003e\n\u003cli\u003eTreatment Use of Investigational Drugs\u003c\/li\u003e\n\u003cli\u003eWaiver of IRB Requirements\u003c\/li\u003e\n\u003cli\u003eDrug Study Designs\u003c\/li\u003e\n\u003cli\u003eEvaluation of Gender Differences\u003c\/li\u003e\n\u003cli\u003eFAQs on Form FDA 1572\u003c\/li\u003e\n\u003cli\u003eFDA IRB Inspections and Clinical Investigators\u003c\/li\u003e\n\u003cli\u003eClinical Investigator Disqualification\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003cp\u003e\u003cstrong style=\"font-size: 0.875rem;\"\u003e•  \u003cspan style=\"color: #ff2a00;\"\u003eNEW\u003c\/span\u003e Informed Consent Guidance (August 2023)\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp align=\"left\" class=\"smallblack\"\u003e\u003cstrong style=\"font-size: 0.875rem;\"\u003e•   ICH Guidelines\u003c\/strong\u003e\u003cspan style=\"font-size: 0.875rem;\"\u003e \u003c\/span\u003e\u003cbr\u003e\u003c\/p\u003e\n\u003cp align=\"left\" class=\"smallblack\" style=\"padding-left: 30px;\"\u003e\u003cspan class=\"smallgray\"\u003e\u003cspan style=\"color: rgb(204, 0, 0);\"\u003e\u003cstrong\u003eE6(R3) FDA\/ICH Good Clinical Practice Guidance (US Step 5)\u003c\/strong\u003e\u003c\/span\u003e\u003cbr\u003eE2A  Clinical Safety Data Management: Definitions and Standards for Expedited Reporting (FDA Step 5)\u003cbr\u003e\u003cspan style=\"color: #000000;\"\u003eE8(R1)     General Considerations for Clinical Trials (FDA Step 5)\u003c\/span\u003e\u003c\/span\u003e\u003c\/p\u003e\n\u003cp align=\"left\" class=\"smallblack\"\u003e\u003cstrong\u003e• Additional FDA Guidance Documents:\u003c\/strong\u003e\u003c\/p\u003e\n\u003cp align=\"left\" class=\"smallblack\" style=\"padding-left: 30px;\"\u003e\u003cspan class=\"smallgray\"\u003e• Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring\u003cbr\u003e\u003c\/span\u003e\u003cspan class=\"smallgray\"\u003e• Qs \u0026amp; As on Monitoring\u003cbr\u003e\u003c\/span\u003e\u003cspan class=\"smallgray\"\u003e• FDA Compliance Program 7348.810: Sponsors, CROs \u0026amp; Monitors\u003cbr\u003e• Adverse Event Reporting to IRBs - Improving Human Subject Protection\u003cbr\u003e• Safety Reporting Requirements for INDs and BA\/BE Studies \u003c\/span\u003e\u003c\/p\u003e\n\u003cp\u003e\u003cspan style=\"font-size: 0.875rem;\"\u003eClick \u003c\/span\u003e\u003ca href=\"https:\/\/cdn.shopify.com\/s\/files\/1\/0856\/8592\/files\/book1b-e6r3coiled.pdf?v=1744396467\" style=\"font-size: 0.875rem;\" rel=\"noopener\" target=\"_blank\"\u003ehere\u003c\/a\u003e\u003cspan style=\"font-size: 0.875rem;\"\u003e to see an enlarged pdf cover\u003c\/span\u003e\u003cbr\u003e\u003c\/p\u003e\n\u003c\/div\u003e\n\u003cdiv id=\"tabs-3\"\u003e\n\u003cp\u003eClick \u003ca rel=\"noopener\" href=\"https:\/\/cdn.shopify.com\/s\/files\/1\/0856\/8592\/files\/book1b-fdae6r3coiled.pdf?v=1760474706\" target=\"_blank\"\u003ehere\u003c\/a\u003e to see an enlarged pdf cover \u003c\/p\u003e\n\u003c\/div\u003e\n\u003c\/div\u003e","brand":"Clinical Research Resources, LLC","offers":[{"title":"Default Title","offer_id":44561131864179,"sku":null,"price":26.95,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0856\/8592\/files\/2026book1bcoiled.png?v=1775164291","url":"https:\/\/www.clinicalresearchresources.com\/products\/book-1b-2026-fda-good-clinical-practice-guide-copy","provider":"Clinical Research Resources, LLC","version":"1.0","type":"link"}