 Readability Test
Readability testing of patient leaflets aims at checking the creation of PIL in accordance to paragraph 3 of the Article 59 of EU directive 2004/27/EC, especially to the findability, applicability and understandability of text. The test design is individually structured user testing interviews involving independent observers and supervisor. All event has carefully prepared in close connection with the sponsor according to the demographic situation of drug's target (indicated) and/or current actual patient group.
Coldwell Pharma Bt. is responsible for all stages of testing, including suggested amendments to the leaflet and test, and for all the listed items below.
The issued signed Final Report will confirm that the success criteria of testing both one by one and altogether have been meant.
Duration of a readability testing is 1,5 - 2 months, which covers the following:
- Writing the protocol
- Writing the test questions
- Preparing the questionnaires
- Defining the target group
- Enrolling of volunteers into the target group
- Checking questionnaire within a pilot test involving 1-3 patients
- Performing the interviews with (at least) 20 patients in two separate rounds
- Performing statistical analyses
- Correction of the patient leaflet if needed
- Repeating the interviews if needed
- Evaluation
- Writing the summary
- Preparing the document for submission to the authority
- Translation of the document into English
- Loan translation of the approved patient leaflet
Contact in Patient Leaflet User test
issues:
Dr Csiktusnádi Kiss Gergely,
Qualified Person in Pharmacovigilance
Phone: +36 30 411 9657
E-mail: csiktusnadi.kiss.gergely@coldwell.hu |
Contact
Coldwell Pharma Bt.
established
in 2001 July
1028 Budapest, Gazda utca 41.
Hungary
Dr. Edit Kósa
managing director
Contact:
info@coldwell.hu
+3630 625 9842
code, design:
adamkobor |
