All unanticipated problem forms and follow up records should be kept in this section; a copy of the forms should be should be kept in this section. A copy of the form kept with the research participant’s record.
An unanticipated problem is defined as any incident, experience, or outcome that meets all of the following criteria:
- 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, or the Investigator Brochure; and (b) the characteristics of the subject population being studied;
- 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 drugs, devices or procedures involved in the research); and
- 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.
Please note that Unanticipated Problems may be physical events (ex. pattern of adverse events), non-physical events (ex. data breach) and events that put non-subjects (ex. researcher staff, bystanders, the public) at risk.
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