{"product_id":"eu-guideline-on-computerised-systems-and-electronic-data-in-clinical-trials-2026-09-01","title":"EU Guideline on Computerised Systems and Electronic Data in Clinical Trials","description":"\u003cp class=\"header-block-grey\"\u003eCourse Description\u003c\/p\u003e\u003cp\u003eThe EU Guideline on computerised systems and electronic data in clinical trials represents a unique perspective on computer system validation (CSV). Unlike conventional CSV guidance, which primarily focuses on system validation, this guideline offers a holistic framework deeply rooted in the context of clinical trials. Notably, it is crafted by EU GCP Inspectors, placing a strong emphasis on the clinical trial setting. While a substantial portion of the guideline aligns with traditional CSV principles, this web seminar is designed to shed light on the areas where it diverges from mainstream CSV methodologies such as Good Automated Manufacturing Practice (GAMP). Participants will delve into these distinctive aspects, gaining valuable insights into electronic data management in clinical trials.\u003c\/p\u003e\u003cp class=\"header-block-grey\"\u003eLearning Objectives\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eExplore the distinctions between the EU Guideline and other computer systems validation guidances and methods\u003c\/li\u003e \u003cli\u003eRecognize the role of metadata in ensuring the integrity and traceability of electronic data\u003c\/li\u003e \u003cli\u003eGrasp the significance of ALCOA++ in maintaining data reliability\u003c\/li\u003e \u003cli\u003eDescribe risk management methods outlined in ICH E6\u003c\/li\u003e \u003cli\u003eDifferentiate between investigator and sponsor systems, understanding their respective roles and responsibilities within the guideline's framework\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eWho Should Attend\u003c\/p\u003e\u003cul type=\"disc\"\u003e \u003cli\u003eQuality Assurance Professionals\u003c\/li\u003e \u003cli\u003eClinical Research Associates\u003c\/li\u003e \u003cli\u003eClinical Trial Leads, Managers, Coordinators, and Investigators\u003c\/li\u003e \u003cli\u003eData Managers\/Data Scientists\/Statisticians\u003c\/li\u003e \u003cli\u003eInformation Technology\/Information Systems (IT\/IS)\u003c\/li\u003e \u003cli\u003eRegulatory Affairs and Compliance Officers\u003c\/li\u003e \u003c\/ul\u003e\u003cp class=\"header-block-grey\"\u003eInstructor\u003c\/p\u003e\u003cp\u003eAndy Lawton\u003c\/p\u003e\u003cp\u003e\u003ca href=\"https:\/\/www.barnettinternational.com\/instructor-biographies\" title=\"Click here for complete trainer biographies\" style=\"font-family:inherit;font-size:inherit;text-align:inherit;text-transform:inherit;white-space:inherit;word-spacing:normal;\"\u003eClick here for complete trainer biographies\u003c\/a\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#: 0778-0000-24-035-L99-P. Released: 2\/24. \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":53375388483949,"sku":"BI17391","price":835.0,"currency_code":"USD","in_stock":true}],"url":"https:\/\/www.barnettinternational.com\/products\/eu-guideline-on-computerised-systems-and-electronic-data-in-clinical-trials-2026-09-01","provider":"Barnett International ","version":"1.0","type":"link"}