Helpdesk Activity Report for Non-Commercial Sponsors

This document is a report detailing the activities of the helpdesk established by the European Medicines Agency (EMA) for non-commercial sponsors (NCSs) over a six-month period. The report outlines the background of the helpdesk, which aims to facilitate communication between NCSs and regulators regarding the Clinical Trials Regulation (EU) No 536/2014 and the Clinical Trial Information System (CTIS). It describes the processes for submitting requests for support, including technical issues and inquiries about CTIS functionalities. The report analyzes the types of incidents and questions raised by NCSs, providing statistics on the resolution of these requests, including timelines and categories of inquiries. Key findings indicate that a significant number of requests pertained to training and known issues, highlighting the challenges faced by NCSs in navigating the CTIS. The report also emphasizes the collaborative role of National Competent Authorities in addressing complex queries.