{"product_id":"fda-s-draft-guidance-on-integrating-randomized-controlled-trials-for-drug-and-biological-products-into-routine-clinical-practice-2026-08-06","title":"FDA's Draft Guidance on Integrating Randomized Controlled Trials for Drug and Biological Products into Routine Clinical Practice","description":"\u003cp class=\"header-block-grey\"\u003eCourse Description\u003c\/p\u003e\u003cp\u003eThe FDA is exploring the integration of randomized controlled drug trials (RCTs) into routine clinical practice. These \"point of care trials\" aim to streamline protocols, focusing on essential data collection. This approach could improve accessibility and diversity in enrollment. This web seminar will review the FDA's initiative on bridging the gap between clinical research and everyday patient care. \u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eLearning Objectives\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eDiscuss Sponsors' role in engaging healthcare institutions\u003c\/li\u003e \u003cli\u003eAssess Clinical Investigators' and local healthcare providers' roles\u003c\/li\u003e \u003cli\u003eExamine processes for aligning trials with clinical practice\u003c\/li\u003e \u003cli\u003eReview quality by design elements in clinical trials\u003c\/li\u003e \u003cli\u003eExplain guidance on informed consent, data privacy, and ethics\u003c\/li\u003e \u003cli\u003eDescribe leveraging real-world data sources in trial conduct\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eWho Should Attend\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eClinical Research Coordinators and Managers\u003c\/li\u003e \u003cli\u003ePrincipal Investigators and Sub-Investigators\u003c\/li\u003e \u003cli\u003eRegulatory Affairs Professionals\u003c\/li\u003e \u003cli\u003eQuality Assurance Specialists\u003c\/li\u003e \u003cli\u003eClinical Trial Sponsors\u003c\/li\u003e \u003cli\u003eIRB\/Ethics Committee Members\u003c\/li\u003e \u003cli\u003eMedical Affairs Professionals\u003c\/li\u003e \u003cli\u003eClinical Operations Team Members\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eInstructor\u003c\/p\u003e\u003cp\u003eElizabeth Ronk Nelson, M.P.H.\u003c\/p\u003e\u003cp\u003e\u003cspan class=\"purple-link\"\u003e\u003ca href=\"https:\/\/stage.barnettinternational.com\/instructor-biographies\" title=\"Click here for complete trainer biographies\"\u003eClick here for complete trainer biographies\u003c\/a\u003e\u003c\/span\u003e\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eRegistration Fees\u003c\/p\u003e\u003cp\u003e$835*\u003c\/p\u003e\u003cp\u003e*Includes up to 20 participants per login at a single location. All participants (up to 20) are eligible for \"Certificates of Attendance,\" and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional logins for other locations, please call +1 781.972.5400 or toll-free in the U.S. 800.856.2556, or email customer.service@barnettinternational.com for pricing.\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eAccreditation Information\u003c\/p\u003e\u003cp\u003eBarnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 1.5 hours (0.15 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation. Barnett International will issue a receipt of completion for earned CEUs within three weeks of program completion. ACPE#: 0778-0000-25-026-L99-P. Released: 2\/25. \u003c\/p\u003e\u003cp align=\"center\"\u003e\u003cspan class=\"bold\"\u003eHold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471. \u003c\/span\u003e \u003cfont color=\"black\" face=\"Verdana, Arial, Helvetica, sans-serif\" size=\"-1\"\u003e \u003c\/font\u003e\u003c\/p\u003e","brand":"Barnett International","offers":[{"title":"Commercial","offer_id":53375390777709,"sku":"BI17351","price":835.0,"currency_code":"USD","in_stock":true}],"url":"https:\/\/www.barnettinternational.com\/products\/fda-s-draft-guidance-on-integrating-randomized-controlled-trials-for-drug-and-biological-products-into-routine-clinical-practice-2026-08-06","provider":"Barnett International ","version":"1.0","type":"link"}