Module 6

04/10/2024

User Testing of Leaflet - Process

Identify key info • MAH input on what are the key areas that should be tested • e.g. complicated dosing, key warnings, side effects

Prelim leaflet review • User testing company input • Be prepared to update leaflet

Protocol • MAH reviews protocol vs regulatory requirements

The Organisation for Professionals in Regulatory Affairs

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User Testing of Leaflet - Process

Pilot questionnaire • ~5 people - general public • Match to intended users (sex, age, varied educational status)

Test leaflet – 1st round • 10 people interviewed •Requires ‘actual’ leaflet • Update leaflet if required

Test leaflet – 2nd round • 10 people interviewed

The Organisation for Professionals in Regulatory Affairs

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