Module 5 Presentations

05/07/2024

Results posting and Clinical study report notifications

• Result posting • CTD : Final results. Currently managed via structured data populated in EudraCT database. This will continue after January 2025 for all trials not transitioned under CTR. • CTR : Interim (as applicable) and Final results. To be managed initially via pdf upload while structured data posting functionality is being developed (timeline TBD), to be considered for all trials authorized or transitioned under CTR. To be complemented by lay person summary results • Clinical Study report • Under current regulatory framework, Marketing Authorization Holder obligation currently limited to centrally approved products under EMA Policy 70 • CTR: obligation to publish CSR for all marketing authorizations as per CTR Article 37.4 (fourth paragraph), within 30 days of completion of marketing authorization procedure. This is the responsibility of the MA Holder • Interplay between Policy 70 and CTR requirements for CSRs yet to be clarified

The Organisation for Professionals in Regulatory Affairs

Regulatory requirements for CTs – EU (Jul2024)

39

CTR: MS supervision

Topic

CTR

Ad-hoc assessment

Specific questions raised by MSC outside of assessments triggered by Sponsor applications. This may relate to a notification send by the sponsor ( e.g. temporary halt, serious breach, unexpected event or urgent safety measures) or related to other aspects of a CT e.g. safety submission made for the same or another CT using the same active substance, class effect seen on another CT… Where an MSC has justified grounds according to CTR Art.77, they may take corrective measures. Unless where immediate action is required, the MSC must ask the sponsor and/or investigator for their opinion before taking (applying) the corrective measure. 7 days Turn around time for that request for Sponsor Opinion.

Corrective measure (require modification/ suspend / revoke authorization)

The Organisation for Professionals in Regulatory Affairs

Regulatory requirements for CTs – EU (Jul2024)

40