Implementing the New GCP R3 Guidelines.
Authored by Carmel Dafna
The updated ICH E6 R3 introduces key improvements from Version 2. Here are fundamental changes, focusing on how they directly impact the sponsor role:
Increased focus on Sponsor Oversight:
The update focuses on the responsibility of the sponsors to have a greater level of oversight. ICH E6 Version 3 emphasizes a more robust and proactive approach to ensure that the sponsors will play a critical role in protecting the participant’s safety and the integrity of clinical trials. This includes increasing the highlight on risk management and quality management systems.
Enhanced Sponsor Quality Assurance:
Version 3 emphasizes a proactive approach to quality management for sponsors and suggests tools and strategies to ensure the highest standards of data integrity, compliance, and overall trial success. This includes recommendations for sponsors to adopt Quality Management Systems, indicating that Sponsor Quality Assurance is adapting and evolving with the clinical research.
Risk-Based Monitoring Integration:
Significant change, allowing sponsors to evaluate how to allocate resources where they are most needed. This ensures sponsors can cultivate a more dynamic and responsive approach to managing study conduct and identifying risks.
Data Integrity and Security:
With an increased focus on data integrity and security, sponsors should be able to protect sensitive information throughout the trial. This not only addresses compliance concerns but also improves the reliability of the data generated.
Continuous Improvement Mindset:
ICH E6 Version 3 asks for continuous improvement from sponsors, expecting them to proactively assess and improve their processes to ensure that sponsors will optimize trial conduct and outcomes.
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