Reportable Events


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

Emory (Non-VA) Guidance and Forms

Start here:

Reporting Obligations for Investigators (ver. 2-14-14) - 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

Timeframes for Reporting Adverse Events, Protocol Deviations, and UPs (ver.10-21-16) - 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

Tools for helping to document and assess events and deviations:

Assessment Form for Events (Internal/External) (ver. 7-18-14)

Assessment Form for Non-Emory Sites Under Emory Sponsor Oversight (ver. 4-28-15)

Assessment Form for Protocol Deviations (ver. 4-28-17)

Root Cause Analysis Worksheet (ver. 11-23-10)

Continuing Review - A Sample Summary of Events (ver. 8-7-2015)

Other Guidance:

Guidance for Submitting Multiple Events at One Time (ver. 11-14-14)

Guidance on How IRB Makes Determinations of Serious or Continuing Noncompliance and UPs (ver. 7-6-15)


VA Guidance and Forms

For information about the reporting procedure for studies conducted at the Atlanta VA, please reference this guidance: https://www.atlanta.va.gov/services/research/Conducting_Human_Research.asp