Named after the silica, main component of computer parts. In silico technologies encompass a large number of approaches that may assist in the prediction of toxicity and fate of new and existing chemicals.
Latest Glossary Definitions
An applicant is the sponsor’s representative for all communications with the competent authorities/ethics committees.
A harmonized application form is used for clinical trial applications across the European Union.
Clinical trial sponsors are required to notify regulatory authorities and ethics committees when their clinical trials have ended.
Upon completion of a clinical trial, the sponsor is required to prepare a detailed report on the study.
- Based in London, the EMA is the EU competent authority and publishes the guidelines on human and veterinary medicines.
The conduct of clinical trials is subject to prior authorization from health authorities, to ensure the protection of clinical trial subjects.
Regulators’ review of a Clinical Trial Application (CTA) is, for a part, based on information about the investigational medicinal product(s) (IMP) provided by
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.