What is readability testing?

Primarily the purpose is to ensure that the testers really will provide feedback about the strengths and weaknesses of the PIL so that a final version can be created that is as accurate and clear as possible.
Preliminary rounds of 3-6 individuals are interviewed to ensure a basic understanding. Then the formal testing itself involves structured interviews of around 12-15 questions with ten participants at the first official stage of the test. These questions are designed to prompt the participant to locate information which reflects specific safety issues in the PIL related to the medicine being tested. The subject is then asked to explain this information in their own words to ensure that they truly understand what they are reading.

The maximum time for the user test is 45 minutes. The questions are random in their approach and do not appear in the same order as they appear on the PIL, allowing ELC to focus on possible problems and ensure that we can implement changes. From there, we can then re-test on a further ten participants.

90%+ correct responses are considered as "satisfactory" of literate subjects that are able to find the information displayed in the PIL and is also the number we look at who should be able to explain the information in their own words. Copies of the user testing questionnaire should be submitted to the Regulatory Authority, along with the responses offered by the participants, the reviewer's written observations and the different versions of the PIL tested.