RUT, Readability User Testing

Readability User Testing for Patient Information Leaflets

M.P.C.A. International BV has been involved in consultation with target groups for readability testing since the beginning of the requirement in November 2005 and has developed a validated webtool to facilitate the work and handle a databank of readers.

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250+

Package leaflets guided to EU submission

100%

PIL user test approval rate to date

48h

Quick turnaround within a 4-week period

About RUT

Readability testing, why it matters

"Reading the information on a leaflet is not the same as understanding it."

The most important part of our work is to ensure that people understand how to use a medicinal drug safely and correctly. Consultation with target groups for Readability testing of Patient Information Leaflets (PIL) generates a validated Module 1.3.4 in the eCTD.

The package leaflet shall reflect the results of consultations with target patient groups to ensure that it is legible, clear and easy to use. M.P.C.A. has developed a validated webtool, visit www.MPCA-leesbaarheid.be

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Validated by these authorities

🇪🇺 EMA (EU)

🇬🇧 MHRA (UK)

🇳🇱 CBG-MEB

🇧🇪 FAGG/FAMHP

🇫🇷 ANSM

🇩🇪 BfArM/PEI

🇮🇹 AIFA

Our RUT offer

What we offer for readability testing

PIL reformatting to current QRD template

Review of Word text (20 or twice 10 interviews) for optimal readability

Mock-up handling

Quick turnaround, as little as 48 hours within 4 weeks

Reports according to guidelines, ready for e-submission

Cost-effective solution, very competitive pricing

100% approval rate to date

Proven effective test methods, online available during special circumstances

Frequently asked questions

Readability User Testing

What is Readability User Testing (RUT)?

Readability User Testing is a process required in the EU to ensure that the package leaflet (PIL) of a medicine is clear and understandable for patients. It involves testing the leaflet with a sample of users to confirm they can find and understand key information.

Is readability testing mandatory for package leaflets?

Yes. EU legislation requires that the package leaflet reflects the results of consultations with target patient groups to ensure it is legible, clear and easy to use. RUT or Readability user testing is the standard way to demonstrate this.

What is your track record with readability testing?

We have guided more than 250 package leaflets to EU submission with a 100% approval rate, providing validated, fast and cost-effective readability testing for pharmaceutical companies.

How do I arrange a readability test for my leaflet?

You can contact our team to discuss readability user testing for your package leaflet.