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User Testing: Delivering Quality In PIL User Testing
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•Article: User Testing: Delivering Quality In PIL User Testing
Written and compiled by Dr. Tim Paget, Medical Director, ICON Development Solutions
The principles of user testing were described some years ago by the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the final document of recommendations is quite comprehensive. The Medicines and Healthcare Products Regulatory Agency (MHRA) has, more recently, issued specific advice, which is more stringent and comprehensive than the EFPIA position and where there are areas of inconsistency, it is generally the more stringent advice that needs to be followed.
A test needs to provide evidence that test participants can find and appropriately use the information in PILs. An experienced interviewer with good interview observational and listening skills should carry out the work. The MHRA has stated that ideally, the writer of the PIL will carry out the interviews, or occasionally accompany the interviewer during testing. This is not always practical, but certainly care should be taken if an agency is carrying out user testing on behalf of a company.
Click Here To Download:•Article: User Testing: Delivering Quality In PIL User Testing
