Reportable Information

Emory Studies reviewed by External IRBs

This page covers Emory and VA reporting. For studies reviewed by another IRB, please see our Collaborative and Multi-site Research.  

Note: Some types of events are considered "egregious" and will still require reporting to the Emory IRB.

Emory (Non-VA) Guidance and Forms

Find out if your event is reportable by using this tool with decision trees - Chart guidance (PDF) 

Reporting Obligations for Investigators (PDF) - What you need to know about what to report and when including:

• Internal and External Unanticipated Problems, Serious Adverse Events, and Deaths
• Protocol Deviations (only internal ones are reportable)
• Noncompliance with laws, regulations, Emory HRPP policies, and procedures, or the requirements of the IRB

Regardless of PI assessment, the following internal deviations are always reportable to the IRB:

• Deviations involving errors during eligibility process that caused the enrollment of an ineligible subject
• Missed protocol-required labs or procedures indicated before study intervention, including pregnancy tests (even if harm did not occur)
• REMS requirements deviations
• Drug dosing errors involving safety concerns (for example, if a subject was dosed incorrectly at a lower or higher dose, or if the drug was not stored per manufacturer indications)
• Consent process errors (for example, when subjects did not receive an adequate explanation of study, or there is no correct documentation of consent)
• Noncompliance is always promptly reportable, but feel free to check with the IRB if unsure whether your situation meets the definition of noncompliance
• Lapse of approval in FDA regulated studies, regardless of the circumstances leading to the lapse. For non-FDA studies an OE is only required if study activities occur during the lapse. 

Timing of Report of Internal Protocol Deviations, Serious Adverse Events (SAEs), Deaths, Confidentiality Breaches, Non-Compliance, and External Events for Emory IRB Approved Studies (*)

Promptly: 10 business days from the date the PI first learned about the event

Periodically: at continuing review

Unanticipated Problem: event that is unanticipated, related and involving risk to participant or serious.

(*)Studies approved by an External IRB: See Collaborative Page.

VA Guidance and Forms

For information about the reporting procedure for studies conducted at the Atlanta VA, please reference this guidance: VA Office of Research & Development Page and Atlanta VA Research Page and Atlanta VA Policy Documents (for those with access).