Page 272 - CHST Research Administration eBook 2 of 2 (Q4 2021)

Include subject #5678 on both UPIRSO and deviation logs
Use shaded space below as needed for follow-up info.
Event is both a UPIRSO and major deviation
#1:
Is event UNEXPECTED?
#2:
Is event PROBABLY or DEFINITELY RELATED3 to participation in the research?
#3: Does event suggest a GREATER RISK of harm than previously known?
2
Rash 1 day after study drug administration on 11/15/16
“probably related” to study drug, so submit RE.
3
Follow-up Date(s):
Listed as risk in IB, protocol, and ICD
No Yes
No No Yes Yes
No Yes
No
Version 2.0
Page 1 of 2
August 1, 2017
Events (Adverse and Non-Adverse) and Unanticipated Problems Involving Risks to Subjects or Others (UPIRSOs) Tracking Log1
Protocol Number: STU 102015-999 Title: APhaseIStudyof... Principal Investigator: Jane Doe, M.D.
***EXAMPLE***
Ref. Subject No. ID
Dates & Report Type
Event
UPIRSO Criteria
Changes or Corrective Actions Made?
Reportable Event?
Initials & Date
1 5678
IRB: 10/4/16
9999
Rash is not identified as risk in IB, protocol, or ICD
IRB:
administration, sponsor determined event is
8675
IRB: 12/21/16
Report Type (initial or follow- up to a previous report)
Brief Description of Event, Problem, or Outcome
If ALL three (3) questions below are answered YES, promptly report the UPIRSO to the IRB.2
If all 3 questions to the left are answered “Yes,” changes or other corrective actions will be or have been made.4,5
If all questions to the left are answered “Yes,” the event is likely a UPIRSO, so submit RE to IRB.6
Initials & date of person completing log
Initial; date event occurred: 10/3/16
Date of PI awareness: 10/3/16
No Yes
No Yes
No Yes
No Yes
No
Follow-up Date(s):
No Yes
No Yes
No Yes
No
Initial; date event occurred: 10/15/16
Date of PI awareness: 10/20/16
Rash 2 days after last study drug administration
No Yes
No Yes
No Yes
No No KB Yes Yes; date 10/22/16
Follow-up Date(s):
No Yes
No No Yes Yes
No Yes
No
11/16/16
Insufficient Info
Insufficient Insufficient Info Info
Yes; date reported to
KB 11/19/16
Initial; date event occurred: 12/16/16
Date of Pi awareness: 12/19/16
Grade 3 anemia
No Yes
No No Yes Yes
No Yes
No
Subject administered incorrect study drug
Insufficient Info
Insufficient Info
Insufficient Info
Yes; date reported to
KB 10/5/16
Insufficient Info
Insufficient Info
Insufficient Info
reported to IRB:
Insufficient Info
Insufficient Info
Insufficient Info
reported to
Insufficient Info
Insufficient Insufficient Info Info
Yes; date JL reported to
Insufficient Info
Insufficient Insufficient Info Info
Yes; dCaRte reported to
No
Yes Yes; date
Not enough info yet. Sponsor determined event is “possibly related” to study drug, so no RE.
Since it happened again so close to study drug
IRB: 11/18/16
IRB:
Report at