{"product_id":"fda-requirements-for-electronic-source-data-in-clinical-investigations-2026-06-13","title":"FDA Requirements for Electronic Source Data in Clinical Investigations","description":"\u003cp class=\"header-block-grey\"\u003eCourse Description\u003c\/p\u003e\u003cp\u003eAs the use of electronic source documentation (eSource) increases, so does the scrutiny for ensuring the integrity of the systems used to generate and retain electronic source data. In late 2010, the FDA issued a draft guidance regarding the use of eSource, providing direction on capturing, using, and archiving electronic data. A final FDA guidance was released in September 2013 focusing on identification and specification of authorized source data originators, the creation of data element identifiers to facilitate examination of the data audit trail, capture of source data into the eCRF, and Investigator responsibilities. This web seminar will review how the requirements for paper source documentation translate to the electronic source document as well as examine real-world examples of the FDA's review of eSource.\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eLearning Objectives\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eNavigate initiatives in the regulatory climate leading to the eSource guidance\u003c\/li\u003e \u003cli\u003eExamine the three tiers of data management\u003c\/li\u003e \u003cli\u003eDiscuss the Clinical Investigator's responsibilities for eSource data origination, integrity, review, release for processing and retention\u003c\/li\u003e \u003cli\u003eAssess the implications of the guidance on source documentation practices and policy\u003c\/li\u003e \u003cli\u003eReview the FDA's expectations and inspection processes for eSource\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eWho Should Attend\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eClinical Research Associates and Managers\u003c\/li\u003e \u003cli\u003eProject Managers\u003c\/li\u003e \u003cli\u003eClinical Investigators and Staff\u003c\/li\u003e \u003cli\u003ePersonnel involved in site and IRB assessment and\/or selection\u003c\/li\u003e \u003cli\u003eAcademia Professionals involved in oversight, documentation, and conduct of clinical research\u003c\/li\u003e \u003cli\u003eQuality Assurance and Compliance Professionals\u003c\/li\u003e \u003cli\u003eData Management 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$735*\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#: 0778-0000-25-003-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\u003c\/p\u003e","brand":"Barnett International","offers":[{"title":"Commercial","offer_id":52823803756909,"sku":"BI17261","price":735.0,"currency_code":"USD","in_stock":true}],"url":"https:\/\/www.barnettinternational.com\/products\/fda-requirements-for-electronic-source-data-in-clinical-investigations-2026-06-13","provider":"Barnett International ","version":"1.0","type":"link"}