Oversight Body or Agency

Reports to or from internal oversight bodies (such as the CC CTO or the OVPR) or outside agencies (such as the FDA, NCI, NIH, or sponsor) should be submitted to the IRBMED for review according to the IRB Timetable for AE or ORIO OR as required in the Study Specific AE Reporting Timetable which may allow for non-concurrent reporting.  The terms Oversight Body or Agency or Entity are interchangeable.