Audit and Oversight Challenges in GCP Systems, with a Focus on Clinical Site Systems
Complimentary
Learning Level: Intermediate
Time: 1000 - 1100 EST
Session Length: 1 hour
The data generated at clinical sites are the foundation of clinical trials, directly influencing patient safety, regulatory approval, and the credibility of trial results. However, ensuring the integrity, reliability, and compliance of this data presents significant challenges for both clinical sites, service providers and sponsors.
This webinar will explore the critical audit and oversight challenges in computerized GCP systems, with a special focus on clinical site systems. Attendees will gain insights into regulatory expectations, practical challenges, and solutions for ensuring compliance and data integrity.
We will show that the GAMP® Good Practice Guide: Validation and Compliance of Computerized GCP Systems and Data – Good eClinical Practice (2nd Edition) provides a comprehensive framework to address these challenges and discuss best practices for system validation, effective collaboration between sponsors and clinical sites, and strategies for meeting regulatory expectations.
Learning Objective
- Importance of Clinical (Site) Data: Understand the vital role clinical site data plays in the success of clinical trials, and the risks posed by inadequate system validation or oversight.
- Regulatory Expectations: Review the EMA’s guidelines on computerized systems and electronic data in clinical trials, including the emphasis on compliance, data integrity, and system validation.
- Sponsor Oversight Challenges: Discuss the difficulties sponsors encounter in establishing robust oversight of clinical site systems, ensuring regulatory compliance, and maintaining trial data integrity across decentralized and hybrid models.
