Webinar | ICH E6 (R3) Data Governance & CSV: Changes-Impact-Compliance

The latest revision of ICH E6 (R3), finalised in January 2025 and enforced in Europe since 23 July 2025, marks a significant shift in clinical trial governance, moving beyond incremental updates to reflect modern trial practices and technologies. The guideline emphasises quality by design, risk-based proportionality, and clearer delineation of responsibilities across sponsors, investigators, and service providers. Of particular importance are the new requirements for Data Governance and Computerised System Validation (CSV). Key updates include:

• A dedicated Data Governance section outlining sponsor and investigator responsibilities across the data lifecycle, including metadata capture, audit trails, and control of unblinding events.
• Mandatory audit trails with clear justification for data changes and traceability for all critical data processes.
• Defined metadata standards and documented procedures for critical data elements, especially in eSource and decentralised trial environments.
• A new section on CSV requiring a risk-based, lifecycle approach to validation of all systems that impact trial data or subject safety.
• System validation documentation, including functional requirements, testing, change control, installation, decommissioning, and performance verification.
• Organisational changes such as updated SOPs, training programs, and inspection readiness planning to align with R3 expectations.

For Australia, while the TGA has endorsed the guideline and is in the process of public consultation, there is no definite implementation date and full regulatory adoption is projected in early 2026. These updates demand a strategic review of current systems and governance practices, especially for organisations relying on legacy tools or fragmented data environments.

Join our upcoming webinar to gain some insights on the ICH E6 (R3) changes, impact and compliance approach.

Register Now for the webinar on 10 September 2025.

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