- Based in London, the EMA is the EU competent authority and publishes the guidelines on human and veterinary medicines.
Latest Glossary Definitions
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.
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, key features of a clinical trial protocol.
Upon completion of a clinical trial, the sponsor is required to prepare a detailed report on the study.
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 effectiveness of risk-management.
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.
An applicant is the sponsor’s representative for all communications with the competent authorities/ethics committees.
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.
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.
The conduct of clinical trials is subject to prior authorization from health authorities, to ensure the protection of clinical trial subjects.