Tracking Log of Reporting
Use this tool to track what unanticipated problems involving risks to subjects or others (UPIRSO) have been reported, to who they’ve been reported, the
date they were reported, and the date of acknowledgement by the entity it was reported to.
Study Title:
HRRC #:
Investigator:
Sponsor:
Event Submitted*
Date of
Document
Date
Submitted
to IRB
Date
Date sent to
Date
Acknowledgement
Submitted to
Safety
Submitted to on file Yes/No
FDA
Monitor
Sponsor
Comments
*Specify name of UPIRSO and participant ID
UNM GCP Tool # 3 (RB)
Version 10/14/08