How should I report problems or violations that meet the reporting requirements?
Please report the problem or violation using the Other Unanticipated Problems and Protocol Violation Report form. This form should be submitted to the IRB within 7 business days of the investigator’s knowledge of the problem or violation. 8. Do I need to submit minor deviations or administrative deviations? If a deviation does not affect the rights, safety, or welfare of subjects or integrity of the research data, it does not need to be reported on the Unanticipated Problem and Protocol Violation Reporting form. Instead, they should be summarized at the time of continuing review. Investigators should contact the IRB if they are unsure whether the event in question needs to be reported using this form, or if it can be summarized during the renewal.
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