CTIS Simplification Task Force

The CTIS Simplification Task Force works to help the Clinical Trials Information System (CTIS) become more efficient and future-proof. The Task Force was established in March 2024 to optimise CTIS functionalities, implement simplifications to CTIS concepts and prepare for modernisation of the CTIS in the coming years. The members of the Task Force are the EMA, the HMA, the European Commission, CTIS product owners, CTIS subject matter experts from the EU Member States, and commercial and non-commercial sponsors.

Objectives of the CTIS Task Force

The objectives of the Task Force are:

• Simplification of CTIS business rules to enable improved use
• Increased operational stability
• Optimisation of training and change management processes

The task force focuses on analysing topics prioritised based on user feedback and has now presented a list of corrective and improvement proposals. Some of these have already been completed, but others are still in progress, like, for example,

• The Clinical Trial Application (CTA) Workflow,
• The Member State Application Programming Interface (API),
• The Collaboration tool,
• The Review of structured data.

More information is available in the document CTIS Simplification Task Force: topics for analysis published on the EMA website.