Matthew Lowrie, quality assurance manager, Almac Clinical Technologies explores how the evolving regulatory guidance around data integrity is impacting clinical trial applications and data.
Key insights:
- Tracing, storage, return, accountability and destruction arrangements must be in place and detailed in the clinical trial application.
- Annex VI also allows for the information on the label to be managed through alternative means, such as a central IXRS system, however some particulars cannot be omitted from labels - such as expiry date.
- IXRS also provides reporting and alert mechanisms to ensure the trial is on track, avoiding any end-of-study push to catch up on tasks and data reconciliation that should be done throughout.
EU Regulation 536/2014 came into effect for new trials in January 2023, impacting supply management practices for clinical trials conducted in the EU, replacing Directive 2001/20/EC. With an aim to simplify trials and enforce consistent rules throughout Europe, these changes have a definitive impact on clinical trial planning activities.