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Data and Safety Monitoring Example Plans: Introduction
Examples of NCI-approved Institutional Data and Safety Monitoring Plans are
shown in this section. These plans (in PDF format) were submitted by
NCI-designated Cancer Centers in response to the NIH and NCI policies governing
data and safety monitoring. They were approved by the NCI Data and Safety
Monitoring Review Panel after a review of the plans based on criteria emanating
from the NCI's
Data and Safety Monitoring Guidelines: Essential Elements.
The reader should note that these plans differ in a number of ways. Each plan is
tailored to and reflects the particular features of a given Cancer Center's
clinical trials program. In addition, each plan has both strengths and
weaknesses, and thus the plans should be studied for the value they have to
offer as different approaches to data and safety monitoring.
We gratefully acknowledge the careful thought and hard work by Cancer Center
leaders and members who produced these Institutional Data and Safety Monitoring
Plans. We especially thank them for their willingness to allow the plans to be
posted here.
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