Readability User Tests
Approval requires the completion of readability tests to ensure that patients can understand the package leaflet. Participants from various age groups and educational backgrounds are selected, and their understanding is assessed through questions.
Several methods are available for conducting readability tests, with Diapharm using an interview-based procedure.
Diapharm’s validated and standardized test method guarantees reliable and, most importantly, rapid results – critical for medicines in the final stages of the approval process.
Key Data
Wherever permissible, Diapharm conducts Bridging Studies as a readability check without active interviews. Bridging Studies replace readability tests by referencing suitable, successfully tested package leaflets.
Readability User Tests include:
- Individual interviews with 20 participants from the target group of the medicine
- Readability tests with native speakers, optionally in the UK or Germany
- Direct evaluations after each interview allow for quick corrections of unclear sections
- Data analysis based on the evaluation criteria of European authorities
- Alternatively: Bridging Study, Focus Test
Diapharm integrates the results into the CTD Module 1.3.4 for submission.
