{"product_id":"clinicaltrials-gov-requirements-clinical-trial-registration-and-trial-results-reporting-expanded-registry-and-results-data-bank-2026-08-13","title":"ClinicalTrials.Gov Requirements: Clinical Trial Registration and Trial Results Reporting, Expanded Registry and Results Data Bank","description":"\u003cp class=\"header-block-grey\"\u003eCourse Description\u003c\/p\u003e\u003cp\u003eThe purpose of the U.S. Department of Health and Human Services (HHS) final rule is to clarify and expand the requirements for the submission of clinical trial registration and results information to the ClinicalTrials.gov database. This web seminar reviews the new requirements published in September 2016, under FDAAA 801 and 42 CFR Part 11, with an implementation date of January 2017, for applicable clinical trials: Submitting registration and clinical trial summary results information, including adverse event information, of drug products (including biological products) and device products to ClinicalTrials.gov. Discussion of the expanded registry and results data bank will be provided along with a summary of all trial registration and results reporting requirements.\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eLearning Objectives\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eExplain the role and expectations of the responsible party\u003c\/li\u003e \u003cli\u003eList clinical trial registration requirements\u003c\/li\u003e \u003cli\u003eIdentify two trial documents that are required to be submitted with the clinical trial results information\u003c\/li\u003e \u003cli\u003eDescribe the trial results reporting requirements for unapproved\/unlicensed\/uncleared products and approved products\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eWho Should Attend\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eTrial Managers\u003c\/li\u003e \u003cli\u003eProject Managers\/Directors\u003c\/li\u003e \u003cli\u003eClinical Quality Assurance\/Compliance Personnel\u003c\/li\u003e \u003cli\u003ePrincipal Investigators\u003c\/li\u003e \u003cli\u003eRegulatory Professionals\u003c\/li\u003e \u003cli\u003eClinical Operations Professionals\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 2 hours (0.2 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#: 0778-0000-23-009-L99-P. Released: 2\/23. \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\u003c\/p\u003e","brand":"Barnett International","offers":[{"title":"Commercial","offer_id":53375390155117,"sku":"BI17365","price":835.0,"currency_code":"USD","in_stock":true}],"url":"https:\/\/www.barnettinternational.com\/products\/clinicaltrials-gov-requirements-clinical-trial-registration-and-trial-results-reporting-expanded-registry-and-results-data-bank-2026-08-13","provider":"Barnett International ","version":"1.0","type":"link"}