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Medical writers needed to quote and undertake PIL readability testings

Since 2005, it is an official requirement of the EMA (European Medicines
Agency) to test the readability of Package Leaflets for all the medicinal
products in consultation with end-users.

Package Leaflets (PLs) are part of the Product Information which the
pharmaceutical companies are required to provide to the EMA for
marketing authorization applications. The Package Leaflet is the leaflet
that end-users, i.e. patients and care-givers, will receive when obtaining
the medicine.

The importance of Readability Testing of PLs lies in the fact that the
end-users must use the medicine correctly for it to be effective; thus, it
is quintessential that they understand the content of the leaflet and act
in accordance with it.

Medical writers experienced in PIL readability testing  for PILs written in English needed as follows:

– 1 medical writer or language lead with excellent knowledge of Product Information and EMA requirements to optimize the source file and to help composing the questionnaire
– 1 medical/scientific writer experienced in describing studies and results to compose the report on Readability Testing
– 1 interviewer to test 25 subjects

Tasks involve:
– Pilot test/interview, with asking 5 subjects:
Score (1-2-3-4-NF-NU):               …………………………
Information found:                                   Yes / No
Information understood:                        Yes / No
Acting appropriately:                               Yes / No
Help question asked:                               Yes / No
What did the participant say:
– Optimization of source file
– Creation of report describing source file, questionnaire, test set-up,
subjects, findings of pilot test and optimizations to source text.
– First test/interview with 10 subjects
– Optimization of source file
– Update of report with findings and optimizations of first test
– Second test/interview with 10 subjects
– Optimization of source file
– Update of report with findings and optimizations of second test

Resources involved:
25 subjects: potential patients, representatives from patient organizations.

If interested, please send your CV and your hourly rate to cv@cra-school.com or
pass this message to other qualified persons


Gina Kalyany
Back office assistant
Clinical Research Insertion Program