Post-Authorization Efficacy Study (PAES)

A Post-Authorization Efficacy Study (PAES) is a study performed after the marketing authorization and aiming principally to further evaluate the efficacy of the medicinal product.

Non-substantial Amendment

A non-substantial amendment is a change to the conduct of the clinical trial that does not have a significant impact on the safety of the subjects or the scientific value of the study.

Substantial Amendment (SA)

A substantial amendment (SA) is a change to the conduct of the clinical trial that has a significant impact on the safety of the subjects or the scientific value of the study.

Voluntary Harmonization Procedure (VHP)

When a sponsor wishes to carry out a clinical trial in two or more EU member states, they can choose to go through the Voluntary Harmonization Procedure (VHP) as an alternative to the classical separate Clinical Trial Application to each Competent Authority.

Informed Consent Form (ICF)

Patients, and/or in specific circumstances their legally designated representative(s), are requested to give written consent before participating in a clinical trial.

Patient Information Leaflet (PIL)

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.

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