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As part of approximately 24 international oncology investigator audits, Norton Audits completed
approximately 75 Investigator monitoring report reviews to identify study noncompliance trends and
to identify high risk Investigators to audit. For each Investigator on the study, Norton
Audits reviewed all monitoring reports and completed a simple one-page review document complete
with ratings and comments that were easily compiled into an overall Investigator risk
assessment.
As part of a separate project, Norton Audits visited several Investigator sites to audit the
monitoring conducted at that site against the protocol requirements, 21 CFR requirements and the
sponsor SOPs and policies.
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