It is the responsibility of the principal investigator to notify CPHS of all protocol deviations within 5 working days of its occurrence or discovery of the deviation. The PI must provide the following items via the iRIS system:

• details of the deviation itself
• did this deviation result in a serious adverse event? (If so, you must submit an adverse event reporting form)
• did this deviation negatively impact the rights or safety of subjects?
• an explanation of the circumstances that led to the deviation
• details of the steps taken to resolve this deviation
• will the subject continue enrollment in the study?
• a description of the plan put into place to prevent the deviation from occurring again