Navigating EMA Policy 0070—How Do We Ensure Compliance?
EMA Policy 0070 requires sponsors to publish anonymized versions of clinical study reports (CSRs) and submission documents submitted in support of a marketing authorization application (MAA) after January 1, 2015. Sponsors must prevent re-identification of people named or referred to in those documents. Anonymizing sensitive information from clinical trial documents while maintaining their clinical utility is a daunting task.
Watch this webinar with Lora Killian, Director of Transparency and Disclosure at Synchrogenix, a Certara company, to learn how EMA Policy 0070 will affect your organization and how to facilitate compliance. She addressed the following critical transparency and disclosure issues:
- The old requirements vs. new detailed requirements for clinical reports
- New timelines and milestones for redacting and publishing clinical reports
- Short-term compliance deliverables: patient narratives, CCI justification tables and validation, and anonymization reports
- Which anonymization techniques best preserve data utility and result interpretation while preventing subject re-identification