Safety Monitoring Plan Form
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Summary
A safety monitoring plan must be designed for greater than minimal risk studies to minimize threats to the safety and welfare of the research participants.
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About Safety Monitoring Plans
A safety monitoring plan must be designed for greater than minimal risk studies to minimize threats to the safety and welfare of the research participants.
When appropriate the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects. (45 CFR 46)
Safety monitoring includes the methods to ensure the safety of the subjects. The details and protections for this part of the plan should be calibrated to the likely harms associated with the research.
See guidance for more details:
https://oprs.research.illinois.edu/forms-templates/guidance/guidance-elements-safety-monitoring-plan
When to Use This Form
If you answered yes to Section 9.7 (Is there SAFETY monitoring plan for this study) in the New Study Application, you need to complete this form.
If you will be using a Safety Monitoring Plan for this study, and if you did not yet select yes in Section 9.7 of the New Study Application, please update the appropriate New Study Application section and then complete this form.
Type of Document
- Forms