Readability user test
Readability user test
RUT – readability compliance
RUT – the readability user test demonstrates the readability and intelligibility of the patient information leaflet (PL) using test subjects
→ full readability test, focus test or bridging report
orangeglobal – the specialist in RUTs in Europe
orangeglobal has been conducting readability studies since the commitment to provide evidence of readability for medicinal products began in 2005. We can therefore help you with our more than two decades and over 1,000 projects of experience.
This means we can adapt the test to your product in a flexible manner but still comply with all of the necessary guidelines and requirements.
We advise you right from the start of your project about your options for a bridging report, full RUT or focus test, and provide information about adapting your patient information leaflet for an optimal test result.
PL preparation
- Adaptation to SmPC and/or official requirements
- Checking for patient-friendly formulation and layout
RUT
- Creation and printing of the patient information leaflet (PL) to be tested
- Pilot test: 3 test subjects
- Main test: 2 × 10 test subjects
- Tests in all 24 EU languages, mainly in English and German
- Final report in English fully formatted for insertion into the eCTD – dossier module 1.3.4, PL in the tested language in module 1.3.1., PL mock-up in module 1.3.2
Focus tests
- Creation and printing of the patient information leaflet (PL) to be tested
- 1 × 10 test subjects
- Tests in all 24 EU languages, mainly in English and German
- Final report in English fully formatted for insertion into the eCTD – dossier module 1.3.4, PL in English in module 1.3.1., PL mock-up in module 1.3.2
Bridging reports
- Consultation on the options for bridging for your patient information leaflet
- Design of the daughter PL mock-up (on request)
- Creation of the bridging report according to the specifications of the official CMDh or EMA template
- Depending on the customer’s wishes, content and layout bridging or pure content with or without layout bridging
Regulatory artwork
- Draft of the patient information leaflet (PL) layout according to customer requirements and based on orangeglobal experience taking into account legal requirements
- Printing of the PL mock-up on paper of the desired paper weight up to a size of DIN A0, including as colour printing
Our expertise guarantees
your success!
