October 2021: European Union CTIS Go-live Planning

On 08 October 2021, EMA published a Go-Live plan for European Union CTIS system. On 21 April 2021, following an independent successful audit of CTIS, the EMA’s Management Board confirmed that CTIS is fully functional and meets the agreed functional specifications. The European Commission subsequently issued a Commission Decision which specifies that the entry into application of the CTR and hence the go-live date for the CTIS will be on 31 January 2022.

This CTIS Go-Live Plan provides an overview of the final remaining activities with the aim to:

  • Address the functional and non-functional areas as set out in the CTIS Project Release Plan for go-live
  • Prioritise the development of the sponsor workspace, followed by the authorities workspace and the public portal
  • Set up of a dedicated EMA Service Desk
  • Address operational and procedural aspects in relation to CTIS and supporting systems
  • Prepare extended stakeholder training
  • Support change management
  • Prepare for the initial scope of safety reporting and monitoring in clinical trials

A dedicated training environment will be made available for use by Member States and sponsors. A phased rollout schedule and controlled access based on needs and European Union Clinical Trials Information System CTIS: Go-live Planning. Access will first be provided to Master Trainers enabling them to train users within their organizations. The rollout is foreseen first for Member State Master Trainers mid-October 2021, followed by providing access to Sponsor Master Trainers from mid-November 2021 and thereafter additional Member States and sponsor users in subsequent batches.