From Wikipedia,
the free encyclopedia
Safety Monitoring of a
clinical trial is conducted by
an independent physician with
relevant expertise. This is
accomplished by review of
Adverse events, immediately
after they occur, with timely
follow-up through resolution.
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.
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