Readability user test (RUT)

We conduct readability user testing of patient information leaflets for our clients in an interview process.

The methods for these tests developed, validated and standardised by Diapharm guarantee reliable, and most importantly, fast results for medicinal products in the last phase of the marketing authorisation procedure.

Our standard turnaround time for sending our final report on the test – which conforms to approvals requirements and is written in English – is only four weeks from you sending us the final mock-up. We conduct the validated readability user testing in English or German.

Key points of our readability user tests

Where permitted we offer bridging studies for readability user testings without active interviewing. Our readability user tests consist of:

  • One-on-one interviews with 20 volunteers from the medicinal products target group
  • Readability User Test with native speakers in either the United Kingdom or Germany
  • Evaluations performed immediately after each interview allowing for confusing passages to be corrected quickly, such reducing costs for the test
  • Our biometricians analyse the data based on the evaluation criteria of the European authorities
  • Alternatively: bridging study, focus test
  • We prepare all documentation for the CTD module 1.3.4 ready for submission


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