PV Bulletin

Clinical Trials E-mail Notifications Activation in CTIS

The Danish Medicines Agency announces the activation of a new email notification feature in CTIS for users running clinical trials.

Primary source: Danish Medicines Agency (DKMA)

PV Impact Brief

Urgency: HighConfidence: high

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).

Action needed

CTIS users are now required to actively monitor notifications daily to ensure timely awareness of safety-related tasks.

Relevant for
Regulatory Intelligence LeadQPPV
Processes impacted
Country Compliance
Owner

Regulatory Intelligence Lead

Review cadence

Review in the next regulatory intelligence cycle.

Policy change details

Document type
Regulatory Update
Policy status
effective
Publication date
2026-06-29
Policy change
The European Medicines Agency (EMA) has introduced a new functionality in the Clinical Trials Information System (CTIS) that allows users to subscribe to daily consolidated email notifications for notices and alerts received in the system over the previous 24 hours.

Key changes

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.

Affected workflows

Country Compliance

Responsible groups

Clinical OperationsPV OperationsRegulatory Affairs

PV impact

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.

View regulator source

Source document details

Exact policy details

Email Notifications Subscription
Users must activate the relevant slider under their personal CTIS profile to subscribe to email notifications.
Applies to: CTIS users
Users remain responsible for actively monitoring notifications in CTIS. · p. 1 · High · Source
Frequency of Notifications
One email notification is sent per day, typically during the night.
Applies to: CTIS users
Containing a consolidated list of the notices and alerts received in CTIS over the past 24 hours. · p. 1 · High · Source

Workflow rule impacts

Country ComplianceCTIS users

Increased responsibility on users to check notifications daily.

Users required to actively monitor notifications to ensure timely awareness of time-sensitive tasks.

Users remain responsible for actively monitoring notifications in CTIS. · p. 1 · High · Source

Extracted documents

Evidence and confidence

Confidence: highSource updated: Jun 29, 2026

Full briefing

Practical implication

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.

View original source

Published from the Firecrawl policy change extraction pipeline.

#Safety Signals#Regulatory Update#effective#Danish Medicines Agency (DKMA)#guidance#policy-change#firecrawl-policy-agent

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