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EMA Initiative To Address Information Overload In CTIS Training Materials

 
• By Vibha Sharma

The European Medicines Agency has launched a phased initiative to consolidate the wide array of training materials for the Clinical Trials Information System, aiming to eliminate duplication, ensure consistency, improve accessibility and enhance user-friendliness.

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EMA is taking steps to streamline CTIS/CTR training materials (Shutterstock)
Key Takeaways
  • The European Medicines Agency has begun revamping training materials relating to the Clinical Trials Information System to address stakeholder feedback about their excessive volume and complexity.
  • Sponsors have complained that the abundance of information sources and complexity of the materials make it challenging to locate information and train new hires.
  • The EMA initiative will be rolled out in stages, starting with enhancements for clinical trial sponsors, followed by updates for member states.
  • The agency is working closely with a diverse group of stakeholders, including academia, industry, and patient representatives, to ensure the revised materials are practical and user-friendly.

The European Medicines Agency has launched an initiative to simplify and redesign its training materials for the Clinical Trials Information System (CTIS) in response to complaints from study sponsors about...

The initiative will also address concerns by member states that the CTIS training materials for regulators need to be clearer and include more role-specific guidance, aligning more closely with their...

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