" /> Study Monitor - CISMeF





Preferred Label : Study Monitor;

NCIt synonyms : Trial Monitor; Monitor; Protocol Monitor;

NCIt definition : An organization, individual, group, or body responsible for the appropriate oversight and monitoring of the conduct of a clinical study. This is done to ensure the safety of participants and the validity and integrity of the study data.;

Alternative definition : CDISC-GLOSS: Person employed by the sponsor or CRO who is responsible for determining that a trial is being conducted in accordance with the protocol and GCP guidance. NOTE: A monitor's duties may include, but are not limited to, helping to plan and initiate a trial, assessing the conduct of trials, and assisting in data analysis, interpretation, and extrapolation. Monitors work with the clinical research coordinator to check all data and documentation from the trial. [from ICH E6, 5.18] See also clinical research associate.;

Details


You can consult :


Nous contacter.
15/06/2024


[Home] [Top]

© Rouen University Hospital. Any partial or total use of this material must mention the source.