The SOP applied by APC Instytut in the User Test of PIL has been developed in accordance with the newest EU Commission Guidelines and „Guidance on user testing” issued by the MHRA. The Process conforms with the requirement of the directive 2001/83/EC as amended.
Bridging and portfolio assessment
According to CMDh it is not necessary to perform user testing on each PIL. If certain conditions of different medicinal products are fulfilled, a bridging of user test results is possible.
APC Instytut can make a portfolio analysis of the similarities between products and asses the possibility of bridging.
The outcome of this service is a bridging report.
The APC Instytut specialists translate the PIL into Polish.
On the basis of the prepared PIL (QRD PIT) we define key questions which are being asked during individual interviews with potential patients.
We recruit a target group of participants who have not taken part in such or similar study for the last 6 months, nor are employed in the Health Care sector. Additional inclusion or exclusion criteria are discussed with the Sponsor.
Execution of Test
The test is performed in a form of individual interviews carried out in Polish, in two groups / potential patients: I group (10 people) and II group (10 people).
This way it is possible to introduce and test any changes in the PIL in full co-operation with the Sponsor.
The essence of the individual interview is to receive the answer, whether after reading the PIL the potential patient is able to find the most important information, understand it and act respectively (three main aspects in the MHRA guidelines: find, understand, action).
All interviews regarding one project are performed by the same experienced moderator.
All interviews are recorded as audio mp3 files.
The report contains the results and conclusions of the test and is ready to file as CTD in competent authorities. The report is written in English or Polish
APC Instytut guarantees the acceptance of the leaflet by the relevant Office; in case of additional questions from the Office, APC Instytut moves to a next stage which provides explanations.
In the event of a repeated examination, the cost of the examination is covered by APC Instytut (but this has never happened before).