European Medicines Agency (EMA)

- Based in London, the EMA is the EU competent authority and publishes the guidelines on human and veterinary medicines.

Case Report Form (CRF)

Data collected in the frame of a clinical trial must be recorded in order to ensure that the protocol is complied with and as a basis for the analysis of the study results.

Investigator's Brochure

Investigators need to be provided with information about the investigational medicinal product (IMP) data, in order to facilitate their understanding of the rationale for, and their compliance with

Clinical Study Report (CSR)

Upon completion of a clinical trial, the sponsor is required to prepare a detailed report on the study.

End of Trial (EoT) declaration

Clinical trial sponsors are required to notify regulatory authorities and ethics committees when their clinical trials have ended.

EudraCT form

A harmonized application form is used for clinical trial applications across the European Union.

Post-Authorization Safety Study (PASS)

A Post-Authorization Safety Study (PASS) is a study performed after the marketing authorization and aiming principally to further evaluate the safety of the medicinal product or to measure the effe

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.

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.

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