Data and Safety Monitoring Example Plans: Introduction
St. Jude Children's Research Hospital Cancer Center
Duke University Comprehensive Cancer Center
Norris Cotton Cancer Center at Dartmouth
University of Wisconsin Comprehensive Cancer Center
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 2.
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.
St. Jude Children's Research Hospital Cancer Center
The following Institutional Data and Safety Monitoring Plan (in PDF format) is from St. Jude Children's Research Hospital Cancer Center, Arthur W. Nienhuis, M.D., Director. The Plan appears in its entirety with the exception of Appendix 4. Contact information is included on the first page of the document for readers who would like to request a copy of Appendix 4.
Once you are viewing the PDF, you can click on the titles listed in the table of contents to jump to that section of the plan.
St. Jude Children's Research Hospital Cancer Center Institutional Data and Safety Monitoring Plan (PDF) 4
Duke University Comprehensive Cancer Center
The following Institutional Data and Safety Monitoring Plan (in PDF format) is from Duke University Comprehensive Cancer Center, Darell Bigner, M.D., Ph.D., Acting Director. The plan appears in its entirety.
Once you are viewing the PDF, you can click on the titles listed in the table of contents to jump to that section of the plan.
Duke Comprehensive Cancer Center DCCC Protocol Review and Monitoring System (PDF) 5
Norris Cotton Cancer Center at Dartmouth
The following Institutional Data and Safety Monitoring Plan (in PDF format) is from Norris Cotton Cancer Center at Dartmouth, Mark A. Israel, M.D., Director. The plan appears in its entirety.
Once you are viewing the PDF, you can click on the titles listed in the table of contents to jump to that section of the plan.
Norris Cotton Cancer Center at Dartmouth Institutional Data and Safety Monitoring Plan (PDF) 6
University of Wisconsin Comprehensive Cancer Center
The following Institutional Data and Safety Monitoring Plan (in PDF format) is from the University of Wisconsin Comprehensive Cancer Center, John E. Niederhuber, M.D., Director. The plan appears in its entirety, including appendices.
Once you are viewing the PDF, you can click on the titles listed in the table of contents to jump to that section of the plan.
University of Wisconsin Comprehensive Cancer Center (UWCCC) Policy and Procedures for Data and Safety Monitoring (PDF) 7
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