CRED SMPC 2024
User testing
One way of demonstrating compliance with Regulation 260 (3).
Diagnostic test • Performance-based not content-based • Flexible • Identifies barriers to understanding but does not provide solutions
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What are we looking for ?
• Key safety messages have been identified
• Patients who are likely to rely on the leaflet can find these messages
• Having found the information users can act appropriately
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