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Safety reporting, adverse events, and protocol deviations

Need assistance with safety reporting and adverse events?

When conducting research that involves human participants, all efforts should be made to ensure participant safety and research protocol adherence. However, sometimes unexpected events occur. Such events should be documented and reported immediately and appropriately. This page provides guidance on identifying and promptly reporting protocol deviations and safety events, should they occur.

 

Protocol deviations and violations

Protocol deviations (an inadvertent act in which the protocol is not followed) and protocol violations (an intentional act in which the protocol is not followed) must be reported to the IRB per sponsor guidelines. The IRB must be informed if any of the following apply to a protocol deviation:

  • It affects subject rights and welfare
  • It affects subject safety
  • It affects the integrity of study data
  • It affects the subject's willingness to continue in the study
  • A report is specifically requested by a government agency, internal/external auditor, medical monitor, or the IRB. 

For Campus Schools/Provost Area projects, or protocols approved by Campus IRB, deviations and unanticipated risks should be reported as soon as they are identified by filling out a Protocol Deviation Form and emailing it to campusirb@duke.edu.

For SoM/SoN projects, or protocols approved by the DUHS IRB, access the policy on unanticipated events for reporting procedures and timelines.

 

Adverse events and unanticipated risks

Unanticipated risks or adverse events include any study-related unexpected events that may increase harm to a participant (a new risk, or an event occurring in greater frequency or intensity than expected) or result in a breach of confidentiality.

An adverse event (AE) must be reported to the IRB if it involves breach or loss of identifiable sensitive information or if the AE:

  • Is more likely than not related to study activities; and
  • Represents a new risk; and
  • Is unanticipated; or
  • Is an expected event that is occurring at a frequency or intensity greater than originally anticipated

For protocols approved by the Campus IRB, any unanticipated risks should be reported to campusirb@duke.edu.

For protocols approved by the DUHS IRB, reporting requirements for adverse events are as follows:

  • Immediately (within 24 hours) upon learning of an unanticipated study-related death, study personnel will notify the IRB via e-mail or fax by providing a brief summary of the event. Then, within 1 week (five business days), study personnel will send to the IRB a Safety Event submission in iRIS.
  • For a reportable serious adverse event (SAE), study personnel will notify the IRB within five business days of the investigator becoming aware of the event. Study personnel will send a Safety Event submission in iRIS.
  • For any other problem or event requiring prompt reporting to the IRB, within ten business days of the investigator becoming aware of the event, study personnel will send to the IRB a Safety Event submission in iRIS.