Readability testing (User consultation)
When is readability testing required?
Module 1.3.4, user consultation, is mandatory for:
- New applications
- Line-extensions
- Renewals
- Dossier updates
Module 1.3.4, user consultation, could also be requested for:
- Certain type II variations
- Extensive changes to the PL
What needs to be shown?
Patients should be able to:
- Find essential information
- Understand the information
- Act upon the information
What alternatives are there?
The options available for module 1.3.4 are:
Bridging report:
Bridging can be used when a similar package leaflet can be found that has already been tested and approved by health authorities.
Focused readability test:
A focused readability test can be used when there is a similar package leaflet already tested and approved, but significant differences can be found in one or more sections of the text.
User consultation is required for the differing sections. Fewer interviews and questions are needed than for a full-scale test.
A focused readability test can also be requested by the health authorities as a complement to a bridging report.
Layout test:
A specific type of focused readability test, where the design and layout (rather than the text) is tested. Once this is done for a company “in-house” design, the result can be bridged to other PILs sharing the same design.
Full-scale user consultation:
Full testing of the leaflet (mock-up). A minimum of 20 people are interviewed and the results are analysed and discussed in a report. The procedure will usually take 5–6 weeks.