Failure to Report: Status Report

 

Time Frame

ORSP / IRB Action Taken

If PI Responds

If No Response

Prior to the due date of the Status Report

 

Automatic notifications are sent via IRBNet

Case resolved

See below

Following the due date

The PI is warned that the Status Report is late

Case resolved

See below

1 week After contact has been made

The PI receives either phone call or email notification from the IRB Administrator

Case resolved

See below

2 weeks After contact has been made

The PI receives a letter from the Director of Research Compliance with the final due date for the Status Report (1 week from the date that the letter is sent).  The letter is posted on IRBNet, mailed to the PI, and mailed to the Sponsor.

Case resolved

 

See below

3 weeks After contact has been made

The PI receives a Notification of Suspension from the Director of Research Compliance.  This notice is posted on IRBNet, mailed to the PI, and mailed to the Sponsor.  In addition this notice is mailed to other institutional entities that are affected by the research.  Research may not resume until the required documents are submitted and administrative approval is obtained.

Case resolved

Termination