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This release marks the introduction of a mandatory channel for ASR submissions via the new CTIS safety module, requiring all clinical trial sponsors in the EU to transition their ASR submission processes to the CTIS platform.
The implementation of the new CTIS safety module will standardize how ASRs are submitted, potentially improving safety reporting efficiency and regulatory compliance across clinical trials in the EU.
Clinical trial sponsors must update their internal SOPs for safety reporting and ensure staff are trained on the new submission steps for ASRs through the CTIS platform.
Regulatory Intelligence Lead
Review in the next regulatory intelligence cycle.
Introduction of a dedicated ASR submission module within CTIS; mandatory use of this module for ASR management; updated step-by-step guidance on report creation, RFI response, and submission workflows.
Clinical trial sponsors must transition their ASR submission processes to the CTIS platform using the new safety module. This requires updating internal SOPs for safety reporting and ensuring staff are trained on the new CTIS submission steps for annual reports.
Clinical trial sponsors must update their internal SOPs for safety reporting and ensure staff are trained on the new submission steps for ASRs through the CTIS platform.
The European Medicines Agency (EMA) has introduced Training Module 18 of the Clinical Trials Information System (CTIS) that establishes a new mandatory safety reporting module for sponsors of clinical trials in the EU. This module outlines the process for creating and submitting Annual Safety Reports (ASRs), which includes updated guidance on report creation, responding to requests for information (RFIs), and submission workflows. Sponsors must update their internal SOPs for safety reporting and ensure that staff are adequately trained in the new submission procedures by the time of mandatory implementation.
What changed: This release marks the introduction of a mandatory channel for ASR submissions via the new CTIS safety module, requiring all clinical trial sponsors in the EU to transition their ASR submission processes to the CTIS platform.
Why it matters: The implementation of the new CTIS safety module will standardize how ASRs are submitted, potentially improving safety reporting efficiency and regulatory compliance across clinical trials in the EU.
Practical implication: Clinical trial sponsors must update their internal SOPs for safety reporting and ensure staff are trained on the new submission steps for ASRs through the CTIS platform.
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