Protocol DeviationTracking Log

Protocol Number: HSC20_____

Title:

Use this log to document all protocol deviationsand track any subsequent reports to the IRB.

Deviations can be: 1) minor or administrative protocol deviations; 2) emergency deviations; or 3) major, non-emergent deviations. Some deviations may also be aUPIRSO or noncompliance that requires prompt reporting to the IRB (review the appropriate IRB policy for guidance).

Deviations / Answer these three questions in order (1 3)
Date Deviation Discovered / Brief Description of the Deviation
(Which part(s) of the IRB-Approved Study Plan were not followed?) / Question 1
Was this deviation in response to an emergency situation, where the deviation was required to eliminate an apparent immediate hazard to the subject?
If Yes – stop and promptly report this to the IRB as a UPIRSO
If No – go to question 2 / Question 2
If you answered “no” to
question 1, did this deviation involve more than one subject?
If Yes, stop and promptly report this to the IRB asNoncompliance
If No, go to question 3 / Question 3
If you answered“no” to
question 2, could this single subject deviation adversely affect the scientific soundness of the research,
or
possibly adversely affect the rights, safety, or welfare of human subjects?
No(go to Q2)
Yes – UPRISO promptly reported to the IRB on: insert date here / No(go to Q3)
Yes – Noncompliance promptly reported to the IRB on: insert date here / Yes – Noncompliance promptly reported to the IRB on: insert date here
No(summarize in next progress report to the IRB)
No(go to Q2)
Yes – UPRISO promptly reported to the IRB on: insert date here / No(go to Q3)
Yes – Noncompliance promptly reported to the IRB on: insert date here / Yes – Noncompliance promptly reported to the IRB on: insert date here
No(summarize in next progress report to the IRB)
No(go to Q2)
Yes – UPRISO promptly reported to the IRB on: insert date here / No(go to Q3)
Yes – Noncompliance promptly reported to the IRB on: insert date here / Yes – Noncompliance promptly reported to the IRB on: insert date here
No(summarize in next progress report to the IRB)
No(go to Q2)
Yes – UPRISO promptly reported to the IRB on: insert date here / No(go to Q3)
Yes – Noncompliance promptly reported to the IRB on: insert date here / Yes – Noncompliance promptly reported to the IRB on: insert date here
No(summarize in next progress report to the IRB)
No(go to Q2)
Yes – UPRISO promptly reported to the IRB on: insert date here / No(go to Q3)
Yes – Noncompliance promptly reported to the IRB on: insert date here / Yes – Noncompliance promptly reported to the IRB on: insert date here
No(summarize in next progress report to the IRB)
No(go to Q2)
Yes – UPRISO promptly reported to the IRB on: insert date here / No(go to Q3)
Yes – Noncompliance promptly reported to the IRB on: insert date here / Yes – Noncompliance promptly reported to the IRB on: insert date here
No(summarize in next progress report to the IRB)
No(go to Q2)
Yes – UPRISO promptly reported to the IRB on: insert date here / No(go to Q3)
Yes – Noncompliance promptly reported to the IRB on: insert date here / Yes – Noncompliance promptly reported to the IRB on: insert date here
No(summarize in next progress report to the IRB)
No(go to Q2)
Yes – UPRISO promptly reported to the IRB on: insert date here / No(go to Q3)
Yes – Noncompliance promptly reported to the IRB on: insert date here / Yes – Noncompliance promptly reported to the IRB on: insert date here
No(summarize in next progress report to the IRB)

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