New CTIS Safety Module Changes How ASRs Are Filed ⚕️ Pure Clinical

Which dates and deadlines do you need to bear in mind?

October 2026: the ‘Safety’ tab appears in CTIS. New ASRs can only be submitted via this tab.
2 months: a transition period for the existing functionality.
14 days: the default deadline for responding to a request for information (RFI). The assessing Member State may shorten this period.
42 days (84 days if an RFI is raised): time allowed for assessing the report.
90 days: after this time, notifications in the Notice Centre are automatically deleted.

What will happen to reports whilst they are being assessed?

The transition period is the riskiest stage. Reports submitted via the legacy ASR functionality can be finalised within two months. Responses to RFIs are then submitted via the existing tabs. After this period, ASRs with a completed assessment will be archived. The EMA and Member States will have access to the archive, but not the sponsor.

Reports that are still under assessment will not be transferred to the new module or archived, and the assessing Member State (saMS or RMS) will finalise them outside CTIS. The advice is simple: before the end of the transition period, download any reports you have submitted, any RFIs and your responses.

Who within the company will be able to view the report?

The new module has its own role and permission model, independent of roles in the clinical trial:

The Sponsor Admin manages access but cannot view the content of the reports.
The Sponsor Safety Admin assigns roles in the ‘Safety’ tab. Current trial administrators (CT Admins) will automatically be assigned this role.
ASR Submitter is the only business role. Only this person creates reports, views RFIs and responds to them. Not even the CT Admin will see the RFIs.

Access is determined by the scope of the role, i.e. ‘All trials’ or ‘Specific trials’. Only the person whose role covers all trials included in the ASR has full access. During the transition period, roles in the old and new tabs will not synchronise.

One report per trial or per substance?

The choice is up to the sponsor. A clinical trial-centric (CT-centric) ASR, covering a single trial, is assessed by the reporting Member State (RMS). The EMA expects that this route will be chosen mainly by academic sponsors. A Substance Group-centric (SG-centric) ASR covers all trials involving the same active substance, including those conducted by different sponsors. It is assessed by the safety assessing Member State (saMS). Only authorised, temporarily halted or suspended trials can be linked to a Substance Group; trials that are under evaluation, whose authorisation has been revoked or that have ended cannot be included.

Where to start before launching?

Gain access to the CTIS training environment (section 6.2.3 of the Sponsor Handbook) and practise submitting a report.
Make sure to assign the ASR Submitter role. Without it, no one will be able to respond to an RFI.
Check that no ‘Change of sponsor’ assessment is ongoing for the trials and that the ORG-ID numbers in OMS are up to date.
Prepare the ASR and accompanying documents (SmPC, IB) in PDF format, up to 50 MB each.

What can no longer be undone?

Once you click ‘Submit’, the ASR can no longer be modified or withdrawn. While an RFI is open, you can only add supporting documents and update the applicant’s contact information, and a new file does not replace the original. The ‘Check’ button validates that mandatory fields and required documents are complete, not the content itself, so the report must be verified beforehand. Documents submitted in the module are never published, but all Member States can access them, including those not concerned by the trials in scope of the ASR.