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Supporting Education and QI in Research (SEQuR)

26. How Do I Report Unanticipated

Problems Involving Risks to Participants or Future Participants and Protocol Deviations?

Investigators are required to report any unanticipated problem that involves risks to participants or others with in ten working days of being aware of the problem. Unanticipated problems involving risks to participants or others is any problem that (1) was unforeseen at the time of occurrence and (2) indicates that participants are at increased risk of harm.

 

Investigators are also required to promptly report protocol deviations. Protocol deviations are events that are a departure from the specific protocol procedures approved by the IRB. Protocol deviations may or may not place participants at risk.  See the IRB Submission Policy for additional information.

 

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