Reportable Event Notification: Reporting site-specific reportable Site-Specific PI events to the sIRB Coordinator Reportable Event Review: Reviewing reportable events to Lead study team determine whether they meet Reviewing IRB prompt reporting criteria Reportable Event Submissions: Submitting reportable events to sIRB Coordinator Submitted via KC IRB the Reviewing IRB (e.g., unanticipated problems, noncompliance, subject complaints) via KC IRB Closure Reports: Providing Reviewing IRB and Relying Site sIRB Coordinator Submitted via KC IRB IRB/HRPP POCs with required information when a study is closed.
Reportable Event Notification: Reporting site-specific reportable events to the sIRB Coordinator Site-Specific PI Reportable Event Review: Reviewing reportable events to determine whether they meet Reviewing IRB prompt reporting criteria Lead study team Reportable Event Submissions: Submitting reportable events to the Reviewing IRB (e.g., unanticipated problems, noncompliance, subject complaints) via KC IRB sIRB Coordinator Submitted via KC IRB Closure Reports: Providing Reviewing IRB and Relying Site IRB/HRPP POCs with required information when a study is closed. sIRB Coordinator Submitted via KC IRB
iu-hso-nih-sirb-communication-plan-template.docx