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
N
Name Patient Use
Supply of a medicinal product which is excluded by a Member State from the provisions…
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B
Briefing Book (or briefing materials)
Documentation submitted to facilitate an Agency meeting, for example to request scientific advice in relation…
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