Reportable Information

This page covers Emory and VA reporting. For studies reviewed by WIRB, please find forms and policies at WIRB. For studies reviewed by other external IRBs, please contact the reviewing IRB for instructions unless advised otherwise.

This page covers Emory and VA reporting. For studies reviewed by WCG, Advarra, or other IRBs IRB, please find forms and policies at their respective websites for their reporting requirements, and see our guidance below and on our Collaborative and Multi-site Research page for local Emory requirements

Acknowledgment Memo 

Starting on July 15, 2019, the Emory IRB will no longer create letters for reportable new information (RNI) submissions that are acknowledged by our office, but that do not meet our reporting requirements detailed in the Policies and Procedures. For example, sponsor-required reports that don't meet the IRB criteria for reporting will not receive a letter, but they will reflect acknowledgment in eIRB. For more information, find this memo (DOCX) for your records or to show to your sponsors if needed, along with the eIRB RE/RNI submission record. 

Emory (Non-VA) Guidance and Forms

Start here:

New Guidance - Chart guidance (PDF) to help you in determining if your event is reportable to the Emory IRB

Reporting Obligations for Investigators (PDF) (ver. 8-28-2020) - 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 (when subjects did not receive an adequate explanation of study, or there is no correct documentation of consent)

Timeframes for Reporting Adverse Events, Protocol Deviations, and UPs (PDF) (ver. 08-28-2020) - At-A-Glance one-page chart.

Note: Noncompliance is always promptly reportable, but feel free to check with the IRB if unsure whether your situation meets the definition of noncompliance

VA Guidance and Forms

For information about the reporting procedure for studies conducted at the Atlanta VA, please reference this guidance: Atlanta VA Health Care System.