Primary source: Danish Medicines Agency (DKMA)
Users must activate the relevant slider in their personal CTIS profile to subscribe to daily email notifications, which will summarize notices and alerts received over the previous 24 hours.
This operational change enhances the monitoring of safety-related notifications, improving timely responses to time-sensitive tasks, such as Requests for Information (RFIs).
CTIS users are now required to actively monitor notifications daily to ensure timely awareness of safety-related tasks.
Regulatory Intelligence Lead
Review in the next regulatory intelligence cycle.
Users can now opt-in for daily email alerts via their personal CTIS profile. This feature consolidates associated notices and alerts (including safety-related ones) into a single nightly email notification.
Improves the efficiency of monitoring safety-related notifications and Requests for Information (RFIs) in CTIS. However, sponsors remain responsible for active monitoring to ensure same-day task completion as required by the Clinical Trials Regulation.
Increased responsibility on users to check notifications daily.
Users required to actively monitor notifications to ensure timely awareness of time-sensitive tasks.
CTIS users are now required to actively monitor notifications daily to ensure timely awareness of safety-related tasks.
CTIS users can now activate a feature that sends daily consolidated email notifications about notices and alerts received in the system. This notification includes safety-related alerts and is aimed at improving the efficiency of monitoring tasks while ensuring sponsors remain responsible for active monitoring.
What changed: Users must activate the relevant slider in their personal CTIS profile to subscribe to daily email notifications, which will summarize notices and alerts received over the previous 24 hours.
Why it matters: This operational change enhances the monitoring of safety-related notifications, improving timely responses to time-sensitive tasks, such as Requests for Information (RFIs).
Practical implication: CTIS users are now required to actively monitor notifications daily to ensure timely awareness of safety-related tasks.
Published from the Firecrawl policy change extraction pipeline.
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