Related Pages Data and Safety Monitoring Guidelines 1 A guide to the formulation of DSM plans for all phases of cancer clinical trials, in accordance with NIH requirements.

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.

• To view the PDF, you will need the Adobe Acrobat Reader software (instructions for downloading a free copy ²).

Duke Comprehensive Cancer Center DCCC Protocol Review and Monitoring System (PDF) ³