HTML Preview Event Process Flow Chart page number 1.
IRB senior staff
review
Sponsor or PI
assess the event
Reportable?
Consultant or IRB
Exec Chair Review
Return to PI
Reportable?
No
Yes
No
IRB review of case
as per SOP RR 408
Potential actions
:
• Modify study or consent
• Suspend enrollment
• Suspend research
• Approve PI’s proposed
changes
Not
Clear
Institutional Officials:
• Vice Provost
• Dean of applicable School
• OGC, as appropriate
• Other compliance offices, as
appropriate
Reportable Events Process Flowchart
Convened IRB
review
IRB determines
reportable: Notify
institutional officials,
sponsors, regulatory
agencies, as required
No further action.
Protocol file
IRB Executive Chair
may suspend study
or require
changes to
eliminate immediate
hazards to subjects
Inform PI of
IRB decision
IRB determines
not reportable
Yes