Resources for Members

The applicant is undertaking a Qualitative Research Study. However, my expertise is in the area of Quantitative Research.

See the presentation entitled Reviewing Qualitative Research Methodologies

The language in the Patient Information Leaflet I am reviewing would be difficult for a patient to understand. Are there any Guidelines available?

See the Plain English tips on the National Adult Literacy Association website

I can't decide if the study I am reviewing is an interventional clinical trial of a medicinal product?

Deciding whether a study involves a 'medicine' or a 'medicinal product' is not always straightforward. A medicinal product is:

"Any substance or combination of substances presented as having properties for treating or preventing disease in human beings; or any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis." Further information on the definition of a medicinal product is provided in the Irish Medicines Board Guide to the Definition of a Human Medicine.

If the study does involve a medicinal product, the next step is to decide if it is an 'interventional trial' of a medicinal product or a 'non-interventional trial' of a medicinal product or a 'post-authorisation safety study.'

A non-interventional trial is:

"a study where the medicinal product(s) is (are) prescribed in the usual manner in accordance with the terms of the marketing authorization, where the assignment of the patient to a particular therapeutic strategy is not decided in advance by a trial protocol but falls within current practice, where the prescription of the medicine is clearly separated from the decision to include the patient in the study and where no additional diagnostic or monitoring procedures shall be applied to the patients and epidemiological methods shall be used for the analysis of collected data."

A post authorisation safety study is:

"A pharmacoepidemiological study or a clinical trial carried out in accordance with the terms of the marketing authorisation, conducted with the aim of identifying or quantifying a safety hazard relating to an authorised medicinal product."