Investigational planAn investigational plan is a medicines development plan to support the authorisation of a medicine for humans. It aims to ensure that the necessary data is obtained through clinical and other studies.
InvestigatorA clinical trial investigator is responsible for the conduct of the trial at a trial site. If a trial is conducted by a team of individuals at a trial site, the investigator is the leader responsible for the team, and is called the principle investigator.
Investigator’s BrochureThe Investigator's Brochure (IB) is a comprehensive document that summarises all the relevant clinical and non-clinical information about the medicine being studied in humans.
An IB contains a 'Summary of Data and Guidance for the Investigator' section, the aim of which is 'to provide the(...)
IBThe Investigator's Brochure (IB) is a comprehensive document that summarises all the relevant clinical and non-clinical information about the medicine being studied in humans.
An IB contains a 'Summary of Data and Guidance for the Investigator' section, the aim of which is 'to provide the(...)
Joint Clinical Assessment (JCA)The JCA is the scientific compilation and the description of a comparative analysis of the available clinical evidence on a health technology in comparison with one or more other health technologies or existing procedures – the full definition is provided under Chapter I Article 2 (6) in the(...)
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