Report Forms
Description
The Report Form application is used to submit problems, information, or events to the IRB for review.
Examples of Problems or Events
Examples of problems or events include, but are not limited to, the following:
- Unanticipated problems or events
- Adverse events (if the AE meets the criteria for an unanticipated problem)
- Deviations
- Adverse device effects
- Breaches of confidentiality or privacy
Examples of Information:
Examples of information include, but are not limited to, the following:
- Data and safety monitoring reports
- Incarceration of a participant
- Complaints from participants (if the complaint meets the criteria for an unanticipated problem)
- New information about the study (for example, from the sponsor, the FDA, other regulatory agencies, etc.)
- Changes in FDA labeling, drug or device withdrawal from marketing
- Warning or determination letters
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 Problem, possible 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.
Related Documents
Related FAQs
- Should I submit an Amendment or a Report Form?
- What does the IRB do with Report Forms after they are submitted?
- What are the consequences for submitting a possible Unanticipated Problem late?
- What are the consequences for submitting possible non-compliance late?
- Once my project is determined exempt, do I need to do anything else with the application?
Related Research Topics
- Unanticipated Problems
- Deviations
- Adverse Device Effects
- Adverse Events
- Breaches of Confidentiality
- Data & Safety Monitoring
- Complaints from Research Participants
- PI Temporary Leave/Sabbatical, etc.