- -Tuesday, 26 January 2010 19:00
Sterling IRB requires Principal Investigators (PI) to promptly report all events that may constitute unanticipated problems involving risk to subjects or others and new or updated safety information relating to the study or study product.
Unanticipated Problems Involving Risk to Subjects or Others are considered, in general, to include any incident, experience, or outcome that meets 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; and (b) the characteristics of the subject population being studied;
- Related or possibly related: to participation in the research (possibly related means that there is a reasonable possibility that the incident, experience, or outcome may have been caused by the study product 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.
The following events/safety information should be reported to Sterling IRB within 10 business days.
- Serious Adverse Events
- Significant Protocol Deviations
- Prospective Protocol Exceptions
- Other Unanticipated Problems
- External SAE reports (e.g., IND Safety Reports)
- Complaints from research subjects (minor subject complaints that are adequately resolved by the research staff do not need to be reported)
- Reports, publications, or interim results or findings
- DMC or DSMB reports and recommendations
- Regulatory Agency Public Health Advisory
- New or updated study product information
- Revised Investigator Brochure
- Revised label / Package Insert
- Revised Device Manual
- Sponsor or regulatory agency recall / withdrawal / clinical hold
- Adverse sponsor or regulatory agency audit or enforcement action
Please see Chapter 7 – Reportable Events and Chapter 10 – Research Conflicts and Non-compliance in the Sterling IRB Investigator Handbook for additional information regarding reporting guidelines.