Readability testing Services

Readability testings of patient information leaflets (PIL) are also referred to as Readability User Testing (RUT).
Knowhownow has been involved, as contractor and subcontractor, with readability testing since the beginning of the requirement in November 2005.

Readability testing services we offer to MAH’s:

A standard readability test includes:

Timeline:

– 4 weeks

Services :

– Independent review of leaflet and mock-up.
– Minor rewriting of the leaflet.
– Recruitment of 20 fresh – native users / consumers
– Preparation of protocol / questionnaire
– Arranging interview facility, all 20 interviews are held under the same conditions. Any disturbances are documented.
– Conducting of the interviews.
– Reporting within 2 weeks after fieldwork.
– Merging of all documents into 1 PDF for submission (module 1.3.4)
– Printing of the mock-up in small batches
– Secure AVG / GDPR
– Documenting of individual detailed social demografic data of respondents (though not mandatory yet, we experience this is required by EMA and MHRA assessors more and more often).
– Documenting subjective ease of finding, PEI mandatory

Additional services:

PIL/Mock-up
– Mock up design: we comply with all National Agency Specifications as well as your company’s design specifications
– Review of the Word text. Amendments are based on technical readabilitity, use of laymen terms, thousands of interviews etc. All in order to optimize readability (i.e. legible, clear and easy to use). Generally prioir to testing.
– PIL reformatting to current QRD
– 3D mock-up preparations

Reporting
– Draw bridging reports
– Quick project turnaround in as little as 2 weeks possible.

Methodology
– Pilot testing
– Focussed testing
– Recruitment of specialist panel / targeted patients (for unusual or orphan drugs)

Reports in compliance with guidelines, ready for submission to these authorities (eCTD compatible). In English or National language. Proven effective test methods according to various guidelines, including the EMA (EU), MHRA (UK), CBG-MEB (NL), FAGG (Belgium), ANSM (France), BfArM and PEI (Germany), AIFA (Italy). Our own experienced native interviewers in the following countries: Netherlands, Belgium, UK, Italy, Germany, France and Sweden.

For more information about our readability testing services or a quotation, please send us an email to info@knowhownow.nl or give us a call at 003143982065.

All readability testings are conducted in accordance with EU code of conduct.

readability user test Knohhownow