Keyword Analysis & Research: sponsor definition clinical trials


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What is FDA sponsor?

FDA requires sponsors (or research monitors hired by them) to monitor the accuracy of the data submitted to FDA in accordance with regulatory requirements. These data are generally in the possession of the clinical investigator.

What is a clinical trial Steering Committee?

Trial Steering Committee (TSC) The role of the Trial Steering Committee (TSC) is to provide the overall supervision of the trial. Ideally, the TSC should include members who are independent of the investigators, their employing organisations, funders and sponsors. The TSC should monitor trial progress and conduct and advise on scientific...

What is a sponsor investigator?

sponsor investigator. An individual who both initiates and conducts, alone or with others, a clinical trial and under whose immediate direction the investigational product is administered to, dispensed to, or used by a subject. The duties of a sponsor-investigator include those of a sponsor and of an investigator.

What is a study sponsor?

A sponsor-investigator, on the other hand, takes on the responsibility as a clinical study sponsor and also conducts or oversees the clinical trial.


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