Reportable New Information


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.

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 does 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 for your records or to show to your sponsors if needed, along with the eIRB RE/RNI submission record.

COVID-19 Guidance for Reportable Events

Review our guidance for more information of when to report a protocol deviation related to the COVID-19 pandemic.

Emory (Non-VA) Guidance and Forms

Start here:

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

Reporting Obligations for Investigators (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

Timeframes for Reporting Adverse Events, Protocol Deviations, and UPs (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

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)

Summary at CR Workbook (ver. 1-30-20)

Summary at CR Workbook-Studies Reviewed by an External IRB (9/7/2020)

Investigator Quality Improvement Assessment. NEW

Other Guidance:

Guidance for Submitting Multiple Events at One Time (ver. 2019)

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