What are the possible consequences for deviating?
Question
What are the possible consequences for deviating?
Answer
The deviation is evaluated to determine if it had a significant effect on the participant’s rights, safety, or welfare, or corrupted the integrity or the resultant scientific data. After the review, the deviation may be completed, returned to the PI to be re-submitted as an unanticipated problem, or evaluated for possible serious or continuing non-compliance.