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
I
In Vitro Diagnostic Medical Device (IVDMD)
Any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus,…
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R
Risk Management Plan (RMP)
A detailed description of the set of pharmacovigilance activities and interventions designed to identify, characterise,…
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