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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