New Information Report
IRB Version Date
April 2016
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1 of 5
Use this form to report new information that may involve noncompliance with the study protocol.
Noncompliance is a failure to comply with the requirements of an applicable law, regulation, or
institutional policy pertaining to the protection of human subjects, and/or with the requirements or
determinations of an IRB.
In instances where noncompliance may be involved, the New Information Report must be
submitted within 5 business days of the occurrence or within 5 business days from the date in
which the LR learned of the occurrence. Submit this report to the Human Research Protections
(HRP) Education and Quality Improvement Program at equip@uci.edu.
Do not use this report to submit an Unanticipated Problem report to the IRB. Unanticipated
Problems must be reported via the UP Report. For additional information, visit the HRP webpage
titled, Reporting of Unanticipated Problems.
PLEASE DO NOT INCLUDE SUBJECT IDENTIFIABLE DATA.
HS# Number:
Protocol Title:
XXXX-XXXX
Lead Researcher:
Administrative Contact:
Person Completing Form:
Date of
Occurrence
Subject Reference #
(do not include subject
identifiers)
Brief Description of New Information
 Attach supporting documents to the email submission.
 If new information involves multiple subjects use the table at the
end of this form.
Date the Lead Researcher became aware of this information:
Protocol Enrollment Status
Total number of subjects currently enrolled at UCI (include a breakdown of overall enrollment if UCI is the IRB of record
for non-UCI sites):
Total number of subjects currently receiving interventions and/or interactions at UCI (include a breakdown of overall
enrollment if UCI is the IRB of record for non-UCI sites):
Is the study currently enrolling at UCI?
Yes
No
If UCI is the IRB of record for non-UCI sites, is the study currently enrolling at non-UCI sites?
Yes
No
N/A
In the opinion of the Lead Researcher does this new information involve foreseeable risks not currently
described in the UCI IRB approved Protocol Narrative and Consent Form?
Yes – If active subjects are enrolled submit a modification request (MOD) describing the revisions and updated
documents promptly.
No – Either the Protocol Narrative and/or the Consent Forms do not need revisions, or this information is already
described in the Protocol Narrative and/or the Consent Form.
Provide a Corrective Action Plan (CAP) to Ensure Noncompliance Does Not Re-occur
New Information Report
IRB Version Date
April 2016
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N/A – Specify why a CAP is not necessary:
I have personally reviewed this information and agree with the above assessment.
(Reports completed by research staff must be signed by the Lead Researcher)
Lead Researcher Signature
Date
New Information Report
IRB Version Date
April 2016
Date of
Occurrence
Subject Reference #
(no identifiers)
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3 of 5
Brief Description of New Information