Patients invited to participate in a clinical trial (=subjects), and/or in specific circumstances their legally designated representative(s), shall be fully informed about the clinical trial in order to make an informed decision regarding their participation.
Patient Information Leaflet
A PIL is a document written specifically for the potential subjects of a clinical trial (or their representative(s)). It includes information about all aspects of the clinical trial relevant to the subject’s participation, and in particular the trial nature, significance, implication and risks. It is provided to the subjects/their representative(s) in support of the oral explanations given by a member of the investigating team.
PIL in the European Union
According to the Directive 2001/20/EC, patient information is one of the aspects to be considered by the Ethics Committees (ECs) in their assessment of a clinical trial. The PIL is therefore included in all EC applications, and will be reviewed for adequacy and completeness. It should be written in the appropriate language(s) of the country concerned by the clinical trial. International, national and local guidances and templates should be followed.
PIL testing is not required, and no formal process is in place; where possible, it is recommended to have the planned PILs read by patients or healthy volunteers of the right age group to make sure the documents are understandable, especially for children, before EC submission.