Report Forms


Report forms are used to submit problems, events, or information issues to the IRB for review. These may include Adverse Events, Protocol Deviations, Reports of Non-Compliance, and Unanticipated Problems.

Report forms can only be submitted for projects once they have been approved or activated (i.e “Active”). They cannot be submitted if the project has not yet completed its initial review.  However, report forms can be submitted on projects that have been closed or are expired. 

Report forms can be submitted at any time, meaning they can be submitted even if another submission (i.e. Amendment or Continuing Review) is currently open.  Additionally, more than one report form can be submitted at a time, if separate events need to be reported. 

Report forms are submitted from the Project Dashboard of the individual project. 

How to Submit a Report Form

Examples of Problems or Events

Examples of problems or events include, but are not limited to, the following:

Examples of Information:

Examples of information include, but are not limited to, the following:

When submitting a Report Form to the IRB

Do not attach revised or updated protocols, consent forms, or other documents that have been changed in the Report Form. These documents must be submitted via an Amendment application, which can be submitted at the same time as the report. Revised protocols, consent forms, or other documents will not be approved if attached in the Report Form. The Report Form is a mechanism for the IRB to review information, not approve updated or revised documents.

Not all problems, new information, or events need to be reported via a Report Form

Only problems, information, or events that meet the definition of a possible Unanticipated Problempossible serious non-compliance, or possible continuing non-compliance need to be submitted via Report Form. The PI is responsible for reviewing all problems, new information, or events to determine if they meet the criteria for a possible UP or possible serious or continuing non-compliance. 

All problems, information, or events that occur should be documented as part of the research records and the PI should document their determination on whether it meets the criteria or not. Templates are available to assist with this documentation.

When in doubt, it is better to submit the event, allowing the IRB to make the determination rather than failing to submit a report that should have been submitted.

Required Timeline for reporting

If the problem, information, or event requires submission via report form, the report form must be submitted as soon as possible following the event but in all cases within 10 business days after the researchers learn of the event.

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