Instructions for Reporting External Adverse Events to the IRB
All reference to 'days' herein refers to 'calendar days' rather than 'working days.'
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Report Type |
Required Timeframe |
Required Information |
Unanticipated Problem Involving Risks to Subjects or Others: A report of any harm or an analysis of drug or study AE trends that suggests the research places subjects or others at a greater risk of harm than was previously known or recognized and/or is significant to the rights and welfare of human subjects in the study.
The judgment that an event, series of events, or analysis is an 'unanticipated problem' may be made by the sponsor, DSMB/DSC, other oversight entity, or the UM investigator.
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Within 7 days of receipt of the report if serious and related
Within 14 days of receipt of the report if non-serious and related |
1. The phrase 'Unanticipated Problem' or the acronym 'UaP' must appear in the submission title (eResearch 1.1) [IRBMED Legacy 2.3 and 6.4].
2. An explanation of how the event is unanticipated.
3. An explanation of how the event is a problem for the study.
4. A copy of the report from the external source.
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Unanticipated Adverse Device Effect (UADE:) Reports from sponsors of any serious adverse effect on the health or safety of subjects, or any life-threatening problem or death caused by, or associated with, a device, if that problem or death was not previously identified in nature, severity, or degree of incidence in the investigational plan (21 CFR 812). |
Within 7 days of receipt of the report |
1. The phrase 'Unanticipated Adverse Device Effect' or the acronym 'UADE' must appear in the submission title (eResearch 1.1) [IRBMED Legacy 2.3 and 6.4].
2. A copy of the sponsor's report.
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Medwatch or other Report of a Single Adverse Event that is not judged an 'unanticipated problem' (see above) but requires a change in the research (e.g. the protocol, consent, risk level, investigator's brochure). |
PI initiated study: Within 7 days of notification of the event
Sponsored or Cooperative-group Study: Within 7 days of notification of the requirement for the change
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1. Justification for why the event necessitates the change(s).
2. Notification of any changes made prior to IRB approval to eliminate apparent immediate hazards to subject(s) or others.
3. A copy of the report from the external source.
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DSMB/DSC Report (may include external and UM events) |
Within 7 days of receipt if a change to the research is required OR the risk/ benefit ratio of the study or subjects' willingness to participate is affected.
Otherwise at SCR
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1. Investigator's response.
2. A copy of the report from the external source.
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Periodic Summaries or Analyses of study-wide adverse events |
Within 7 days of receipt if a change to the research is required OR the risk/ benefit ratio of the study or subjects' willingness to participate is affected.
Otherwise at SCR
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1. Investigator's response.
2. A copy of the report.
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Medwatch or other Report of a Single** Adverse Event where both of the following are true:
- Event is not deemed an unanticipated problem
- Event does not require a change in the research (e.g. the protocol, consent, investigator's brochure).
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An IRB submission is not required but may be accepted with the investigator's justification for submitting the report |
1. Investigator's justification or reasons for submitting a report that is not required.
2. A copy of the report
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Follow-up Report on a Single Adverse Event deemed an unanticipated problem
- Unanticipated problem judgment may have been made with the initial report or may be a new assessment based upon new information
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Within 7 days of receipt of the report if serious and related
Within 14 days of receipt of the report if non-serious and related |
1. The phrase 'Unanticipated Problem' or the acronym 'UaP' must appear in the submission title (eResearch 1.1) [IRBMED Legacy 2.3 and 6.4].
2. An explanation of how the event is unanticipated noting if this assessment is new, and if so, why.
3. An explanation of how the event is a problem for the study.
4. A copy of the report from the external source
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Follow-up Report on a Single Adverse Event not deemed an unanticipated problem |
An IRB submission is not required but may be accepted with the investigator's justification for submitting the report |
1. Investigator's justification or reasons for submitting a report that is not required.
2. A copy of the report
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