What are the consequences for submitting possible non-compliance late?

Question

What are the consequences for submitting possible non-compliance late?


Answer

Researchers are required to submit reports that may represent serious or continuing non-compliance as soon as possible after the PI learns of the deviation, but in all cases within 10 working days. If the report is submitted late, a written explanation of its tardiness must accompany the report. Late reports may be reviewed for additional non-compliance.

When in doubt, it is better to submit the deviation, allowing the IRB to make the determination rather than failing to submit a report that should have been submitted.

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