You are advised to:
– Draw up a new protocol for each product
– Include questions that address all the important and difficult issues, and
use rigorous assessment criteria
– Include a set of expected correct answers
– Design the test to last no more than 45 minutes, to avoid tiring
participants
– Ensure that the questions reflect any specific safety and compliance
issues related to the medicine being tested. Testing is most beneficial
when the questions relate to areas where patients’ fears are greatest,
such as side effects. Avoiding serious safety issues with a medicine
during user testing of the PIL would invalidate the test.