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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

P

Patient Information Leaflet (PIL)

Patients invited to participate in a clinical trial (=subjects), and/or in specific circumstances their legally…

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C

Chemistry, Manufacturing, and Control (CMC)

A critical aspect of pharmaceutical development processes and applications. CMC includes bulk drug substance chemical…

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