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Glossary

Monitoring Plan

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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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F

Field Safety Notice (FSN)

A communication to customers and/or users sent out by a manufacturer or its representative in…

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