Describes the monitoring methods, responsibilities, and requirements for the trial. It includes a brief description of the study, its objectives, and the critical data and study procedures.
The plan describes the reference policies and procedures to follow.
Other glossary definitions
R
Reference safety information
In periodic benefit-risk evaluation reports for medicinal products, all relevant safety information contained in the…
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P
Pre-Sub Meeting
FDA Pre-Sub meetings are available for manufacturers to obtain regulatory feedback on various medical device…
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