Applicant for Clinical Trial Applications (CTA)

An applicant is the sponsor’s representative for all communications with the competent authorities/ethics committees.

European Union (EU) Legal Representative

Sponsors who are not based in the EU/EEA must appoint a legal representative based in the EU/EEA.

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 sep

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 ord

European Directorate for the Quality of Medicines (EDQM)

The quality of medicines and healthcare products in Europe is harmonized through different initiatives under the supervision of the European Council.

Qualified Person for PharmacoVigilance (QPPV)

Marketing Authorization Holders are responsible for monitoring the safety of products placed on the market.

Investigational New Drug (IND)

Administering an investigational drug to humans is subject to prior approval from regulatory authorities.

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