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.
Is the European Databank on Medical Devices. It’s a secure, web-based portal that acts as a central hive for the exchange of information between national competent authorities and the European Commission.
Latest Glossary Definitions
A harmonized application form is used for clinical trial applications across the European Union.
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 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.
An applicant is the sponsor’s representative for all communications with the competent authorities/ethics committees.
Administering an investigational drug to humans is subject to prior approval from regulatory authorities.
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.
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.
- Based in London, the EMA is the EU competent authority and publishes the guidelines on human and veterinary medicines.