The OHSU Cl Data and Safety Monitoring Plan {DSMP) follows the policy of the National Cancer Institute for data and safety monitoring of investigator-initiated clinical trials. The purpose of the DSMP is to insure the safety of study participants, the validity of research data and the appropriate termination of studies for which significant benefits or risks have been uncovered or when it appears that the trial cannot be concluded successfully. We also assert that monitoring is a critical instrument for human subjects protection, as it provides investigators direct feedback about their research practices and identifies areas for improvement that can be identified in no other way. It is one of the only mechanisms by which the DSMC can ensure that the study is being conducted in accordance with the IRB and CRRC-approved protocol. When performed in a quality assurance fashion with an educational rather than policing focus, objective monitoring of actual protocol procedures is also one of the most important tools we have to educate investigators on the practical aspects of human subjects protections. Examination of actual research records is the only to way to uncover certain potentially serious compliance issues, such as improperly documented consent, failing to meet eligibility requirements or failure to report adverse events.
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