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Safety Monitoring of a clinical trial is conducted by an independent physician with relevant expertise. This is accomplished by review of adverse event, immediately after they occur, with timely follow-up through resolution.
Additional recommended knowledge
Responsibility for data and safety monitoring depends on the phase of the study and may be conducted by sponsor or CRO staff or contractor, and/or by the Principal clinical investigator/project manager conducting the study. Regardless of the method used, monitoring must be performed on a regular basis. Oversight of the monitoring activity is the responsibility of the sponsor.
|This article is licensed under the GNU Free Documentation License. It uses material from the Wikipedia article "Safety_monitoring". A list of authors is available in Wikipedia.|