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Reportable Events Instructions Event Type Prospective Deviation Request Reportable Event Event Attachments Post Review Communication IRB Determinations (HRP ONLY)

Reportable Events Instructions

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  • Unanticipated Problems or Serious/Continuing must be reported within 5 business days of the event or within 5 business days from the date in which the Lead Researcher (LR) learned of the event. 


  • Prospective Deviations must be requested at least 4 business days (96 hours) prior to the planned deviation.


  • If changes to the protocol and/or consent are required as a result of the event, also submit an amendment.


  • Do NOT include participant identifiers (e.g., medical record number) in the report, or in the supporting documentation.


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Event Type

Did the reportable event occur at an UCI site or at a non-UCI site where the UCI IRB is the IRB of record?

Choose one that applies:

  1. Yes
  2. No

Has a hold or a suspension been issued by the FDA, a sponsor, or a DSMB, for an event that is possibly related to risk to human subjects?

Choose one that applies:

  1. Yes - An Unanticipated Problem must be submitted to the IRB
  2. No
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Was the hold/suspension issued for a clinical trial involving Investigational Radiopharmaceutical(s)?

Choose one that applies:

  1. Yes - Radiation Safety Committee Review Required
  2. No
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STOP! The UCI IRB does not require a report for this external (non-UCI) reportable event.


Select Save at the top right and exit the application.

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Are you reporting an event for an IRB or sIRB protocol?

Choose one that applies:

  1. IRB (UCI is the IRB of Record)
  2. sIRB (UCI relies on a non-UCI IRB)
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Need help determining the event type?

Choose one that applies:

  1. Yes - Go to the Reportable Event Questionnaire
  2. No
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Reportable Event Questionnaire

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Is this event serious and/or continuing noncompliance?


Noncompliance is when a research team fails 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.


Serious noncompliance is noncompliance that has a significant adverse impact on the rights or welfare of participants or on the integrity of the data.


Continuing Noncompliance is a pattern of noncompliance that indicates an inability or unwillingness to comply with applicable laws, regulations, or institutional policies pertaining to the protection of human subjects and/or with the requirements or determinations of an IRB.

Choose one that applies:

  1. Yes
  2. No

Is the event an unanticipated problem?


In accordance with Federal regulations, an Unanticipated Problem is defined as:


  1. Unexpected (in terms of nature, severity, or frequency) given (a) the research procedures that are described in the protocol-related documents, such as the IRB-approved research protocol and informed consent document; and (b) the characteristics of the subject population being studied; and
  2. Related or possibly related to participation in the research (possibly related means there is a reasonable possibility that the incident, experience, or outcome may have been caused by the procedures involved in the research); and
  3. Suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized.


Reasonable judgment must be used when determining what constitutes an unanticipated problem. When in doubt, it is best to err on the side of reporting the event or contact the Human Research Protections (HRP) staff for guidance.

Choose one that applies:

  1. Yes
  2. No
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Select the following Event Type: Serious/Continuing Noncompliance

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Select the following Event Type: Unanticipated Problem & Serious/Continuing Noncompliance

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Select the following Event Type: Unanticipated Problem

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Is the event a non-emergency, major deviation?


IMPORTANT! Non-emergency, major deviations should be submitted to the UCI IRB for prospective review (in advance of the event).

Choose one that applies:

  1. Yes
  2. No
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Does the Sponsor require the submission of a report to the UCI IRB?

Choose one that applies:

  1. Yes
  2. No
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STOP! The event is not reportable. A Deviation Tracking Log may be submitted at the time of renewal.


Select Save at the top right and exit the application.

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STOP! The event is not reportable.


Select Save at the top right and exit the application.

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Will the deviation occur within 96 hours?

Choose one that applies:

  1. Yes
  2. No
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STOP! Please report your non-emergency deviation as an amendment.


  1. Select Save at the top right and exit the application.
  2. Go to the protocol and then select Amend.
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Select the following Event Type: Prospective Deviation

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Event Type:

Choose one that applies:

  1. Prospective Major Deviation that Occurs within 96 Hours
  2. Serious/Continuing Noncompliance
  3. Unanticipated Problem
  4. Unanticipated Problem & Serious/Continuing Noncompliance
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Prospective Deviation Request

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Use this form to request a prospective protocol deviation where no more than (3) subjects may be impacted. 


IMPORTANT! Please allow for at least 4 business days (96 hours) advance notice for this request to be processed by the IRB. 


If the request does not meet the criteria for subcommittee review, it will be sent to the convened IRB.

Date Needed by:

Date: MM/DD/YYYY

Has the sponsor or designee (e.g., Department Chair if not externally funded) approved this prospective deviation?

Choose one that applies:

  1. Yes
  2. No

REQUIRED! Submit a copy of the sponsor or designee?s approval in the Reportable Event Attachments section.


For Investigator Initiated studies or studies where the Lead Researcher is also the sponsor of the IND or IDE, provide a copy of Lead Unit's (i.e. Department Chair) approval of this prospective deviation.

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ATTENTION! Do not submit the event without the requisite documentation from the Sponsor or Lead Unit.


Please save the prospective deviation request and complete it when the requisite documentation is available to attach with the submission.

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Has this same prospective deviation been submitted on any other occasion for this study?

Choose one that applies:

  1. Yes
  2. No

Specify the other occasion where the same prospective deviation has been submitted:

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Enter date when the same prospective deviation was submitted:

Date: MM/DD/YYYY
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Do you think that this same prospective deviation may be requested again?

Choose one that applies:

  1. Yes
  2. No

Specify how this same prospective deviation will be requested again:

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Please specify the type of prospective deviation:

Choose one that applies:

  1. Request for deviation in inclusion/exclusion criteria
  2. Request for deviation in study procedures
  3. Request for deviation in compensation of subjects
  4. Other

Specify the 'Other' type of prospective deviation:

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Provide a thorough description of the prospective deviation (i.e., what will be done differently for subject(s), when and where will this occur, etc.):

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For a multi-center study where UCI is the IRB of Record and the request is for a non-UCI relying site, specify the site of the request for the prospective deviation (if applicable):

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Specify the number of subjects impacted by this prospective deviation request (can be no more than 3):

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Specify the rationale for the prospective deviation:

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In assessing the risks related to this request, check all that apply:

Select all that apply:

  • The request will affect the integrity of the data for the study
  • There is an increased risk to subjects immediately impacted by this deviation
  • There is an increased risk to subjects overall based on this deviation
  • Other
  • None of the above

Specify 'Other' related risk(s) to this request:

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Reportable Event

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Date the Lead Researcher became aware of the event:

Date: MM/DD/YYYY

Event Date:

Date: MM/DD/YYYY

Briefly describe/summarize the event using a few key words or phrases:

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Provide a detailed description of the event:

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Event Location

Did the event occur at a non-UCI site, where UCI serves as IRB of Record?

Choose one that applies:

  1. Yes
  2. No

Identify non-UCI site(s) and location(s) (e.g. CHOC, UCLA):

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Has the event been reported to the non-UCI site(s)?

Choose one that applies:

  1. Yes
  2. No
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REQUIRED! Submit supporting documentation from non-UCI, relying site in the Reportable Event Attachments section.

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Explain why the event has NOT been reported to the non-UCI, relying site:

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Protected Health Information

Does the event involve a potential breach of Protected Health Information (PHI)?

Choose one that applies:

  1. Yes
  2. No

IMPORTANT! All potential breaches of PHI must be immediately reported to the UCI Health Privacy Compliance Officer at 714-456-3672 or hacompliance@uci.edu

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Serious/Continuing Noncompliance

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Category(ies) of the incident (check all that apply):

Select all that apply:

  • Risk of breach or breach of confidentiality
  • Research conducted without IRB approval
  • Issues related to informed consent or assent
  • Failure to follow IRB-approved protocol
  • Other - see description

Describe how the event is potential serious and/or continuing noncompliance:

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Unanticipated Problem

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Identify the Study Drug/ Biologic/ Device/ Treatment Intervention related to the event (if applicable):

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Explain why this event is unexpected:

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Explain how this event is related to the research:

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Explain how this event suggests the research may expose participants or others to a greater risk of harm than previously recognized:

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Participants

Participant Enrollment Status:

Choose one that applies:

  1. Participant enrollment has yet to begin
  2. Participant enrollment ongoing ? research procedures ongoing
  3. Participant enrollment temporarily on hold ? research procedures stopped
  4. Participant enrollment temporarily on hold ? research procedures ongoing
  5. Participant enrollment completed ? research procedures ongoing
  6. Participant enrollment completed ? subject on long term follow up only
  7. Participant completed ? including analysis of identifiable information
  8. Participant enrollment and follow-up completed ? analysis of identifiable information ongoing

List all participants involved:

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Date of Occurrence:

Date: MM/DD/YYYY

Participant Reference Number:

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Participant Age:

What is the status of the participant(s) involvement:

Choose one that applies:

  1. On Study - Receiving Study Intervention
  2. On Study - Study Intervention Temporarily on Hold
  3. On Study - Study Intervention Permanently Discontinued / Subject Follow Up Only
  4. Not on Study - Subject Withdrawn
  5. Participant Death
  6. Not Applicable
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Event Status

What is the status of the event?

Choose one that applies:

  1. Resolved
  2. Unresolved

IMPORTANT! If unresolved, a follow-up report must be submitted as soon as additional information becomes available.

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If resolved, explain the outcome of the event; if unresolved, explain the current status:

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Entities Notifed

What entities have been notified of the event?

Select all that apply:

  • None
  • Study Sponsor
  • UCI Health Compliance & Privacy Office (e.g. in the event of a breach of PHI)
  • UCI Cancer Center Data Monitoring Committee
  • UCI Institutional Biosafety / Environmental Health and Safety
  • Food and Drug Administration (FDA)
  • National Cancer Institute (NCI) Adverse Event Expedited Reporting System (AdEERS)
  • National Institutes of Health (NIH) Office of Biotechnology Activities (OBA)
  • Other

Specify the 'Other' entity that has been notified of the event:

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Corrective Action

Will a Corrective Action Plan (CAP) be necessary to address the event?

Choose one that applies:

  1. Yes
  2. No

CAP Category(ies) (check all that apply):

Select all that apply:

  • Audit plan for research
  • Education/training for PI/study team
  • Re-consent or notifying subjects
  • Revising protocol or consent form
  • Other - see CAP description
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Provide a CAP to address the event and to ensure that noncompliance does not re-occur:

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Alternatively, submit the CAP as a separate document in the Reportable Event Attachments section.

Select all that apply:

  • Check here to confirm that the CAP is attached
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Specify why a CAP is not necessary:

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Does the Lead Researcher consider this event to constitute a significant new finding?

Choose one that applies:

  1. Yes
  2. No

Currently enrolled subjects must be notified of the new findings.


Enter the submission date for the corresponding amendment or explain why an amendment has not been submitted.

Date: MM/DD/YYYY
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Justify why currently enrolled subjects should not be notified (re-consented) of this reportable event:

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Does the Lead Researcher consider that this event affects previously enrolled subjects who are no longer receiving active study treatment or who have already completed the study?

Choose one that applies:

  1. Yes
  2. No
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Submit an amendment with the notification letter to participants.


Enter the submission date for the corresponding amendment or explain why an amendment has not been submitted.

Date: MM/DD/YYYY
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Explain why an amendment has not already been submitted:

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Justify why previously enrolled subjects should not be notified of this reportable event:

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External IRB Determination

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Specify the external IRB's determination of the event:


If the external IRB has not made a determination yet, specify the anticipated date this determination will be made. For WGC or Advarra IRB, enter one month from the event submit date.

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Event Attachments

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Submit any supporting documents for the event in the attachments section below.


IMPORTANT! Do NOT attach documents related to amendments here.

Select all that apply:

  • Check here to confirm no supporting documents are available

Attachments - Test

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Upload File...
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End of submission form - please 'Submit'.

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Post Review Communication

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Please address the HRP/IRB comments and ?Resubmit? by the stated deadline.

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IRB Determinations (HRP ONLY)

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Event Determination:

Select all that apply:

  • More Information Required
  • Prospective Deviation is acceptable
  • Not a Reportable Event
  • Serious Noncompliance
  • Continuing Noncompliance
  • Unanticipated Problem

Date of Determination:

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CAPA Determination:

Select all that apply:

  • Not required
  • Revisions required
  • Acceptable as is - no further corrective actions required
  • Ongoing corrective actions
  • Suspension/Termination
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Event Status:

Choose one that applies:

  1. Resolved
  2. Unresolved
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Date of Resolution:

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