CTIS: EMA´s Risk Mitigation Plan

Recommendation

5-7 November 2024
Hamburg, Germany

GMP meets Development
GMP and FDA Compliance in Pharmaceutical Development and IMP Manufacturing

A risk mitigation plan (RMP) is available to help CTIS (Clinical Trials Information System) users carry out regular activities within the system in different risk scenarios. The Agency published the CTIS risk mitigation plan in February 2023. For its setup, the EMA worked together with Members States and the European Commission. The RMP is effective immediately and is subject to constant review and update to ensure business as usual operations.

However, the following User Support activities are still listed in status "planned":

• Increase user support service capacity, provided by EMA experts, on CTIS functionalities and establish dedicated priority teams, working on specific system areas to manage incidents.
• Draft a (communication/training) plan for the EMA staff that provides users support to CTIS users, in order to swiftly and efficiently address issues raised from CTIS in production environment.
• Develop a report and continuously monitor workload for reported issues, including submitted clinical trial applications.

In case of system failure and persistent system downtime, submissions of clinical trials data, assessment and supervision of authorized trials outside CTIS should be allowed. The exchange outside CTIS should be enabled especially in those cases when safety and wellbeing of clinical trials participants' is at risk, for example, in case of safety issues to be notified to the Regulatory Authorities. In the event of prolonged down time, such activity should also be enabled for critical new clinical trial applications.

For more information please see EMA´s Clinical Trials Information System - Risk Management Plan published on the agency´s website in Development of the Clinical Trials Information System.