Course Description

The 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.

Learning Objectives

• Explore the distinctions between the EU Guideline and other computer systems validation guidances and methods
• Recognize the role of metadata in ensuring the integrity and traceability of electronic data
• Grasp the significance of ALCOA++ in maintaining data reliability
• Describe risk management methods outlined in ICH E6
• Differentiate between investigator and sponsor systems, understanding their respective roles and responsibilities within the guideline’s framework

Who Should Attend

• Quality Assurance Professionals
• Clinical Research Associates
• Clinical Trial Leads, Managers, Coordinators, and Investigators
• Data Managers/Data Scientists/Statisticians
• Information Technology/Information Systems (IT/IS)
• Regulatory Affairs and Compliance Officers

Instructor

Andy Lawton

Click here for complete trainer biographies

Registration Fees

$835

Includes up to 20 participants at one site. 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 sites, please call +1 781.972.5400 or toll-free in the U.S. 800.856.2556 for pricing.

Note: Due to COVID-19, we understand that most teams cannot currently dial-in together. As such, we are able to offer additional logins at a highly reduced rate. Please contact Barnett Customer Service at +1 781.972.5400 or toll-free in the U.S. 800.856.2556 to register with your additional participants requiring login credentials. Or email Customer Service at: customer.service@barnettinternational.com 

Accreditation Information

Barnett 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. 

Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.