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
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 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)
Guidance for Submitting Multiple Events at One Time (ver. 11-14-14)
VA Guidance and Forms
Promptly reportable events (including safety events and noncompliance) must be reported directly to the AVAMC Research Administrative Office within five days of discovery, instead of to the Emory IRB. The RAO then transmits the information to the Emory IRB. NOTE: This requirement is in addition to other applicable reporting requirements (e.g., reporting to the sponsor under FDA requirements). The unfounded classification of an SAE as “anticipated” constitutes serious noncompliance.
Atlanta VA forms and guidance documents may be found on the AVAMC website:
VA Reportable Event Policy - note VA-specific definitions:
- Adverse Event (AE): An untoward physical or psychological occurrence in a human subject participating in reserach
- Serious Adverse Event (SAE) - An Adverse Event in human subjects participating in research that results in death, a life-threatening experience, inpatient hospitalization, prolongation of hospitalization, persistent or significant disability or incapacity, congenital, anomaly, or birth defect, or that requires medical, surgical, behavioral, social, or other, intervention to prevent such an outcome.
- Serious Problem (SP) – A serious problem is a problem in human research that may reasonably be regarded as:
- Involving substantive harm, or a genuine risk of substantive harm, to the safety, rights, or welfare of human research subjects, research staff, or others; OR
- Substantively compromising the effectiveness of a facility’s human research protection or human research oversight programs.
- Unanticipated Adverse Event or Unanticipated Problem (UP) - The adverse event or problem is either new or greater than previously known in terms of nature, severity, or frequency of occurrence. In order for the event to be unanticipated, it cannot be listed in the study protocol, the Informed Consent, Investigator’s Brochure, Sponsor’s Information, or expected in the study population. Note: “Serious Problems” may include UPs.
- Related – The event or problem may reasonably be regarded as caused by, or as probably caused by, the research.
- Serious non-compliance is a failure to adhere to the laws, regulations, or policies governing research involving human participants that may reasonably be regarded as:
- Involving substantive harm, or a genuine risk of substantive harm, to the safety, rights, or welfare of human research participants, research staff, or others.
- Substantively compromising the effectiveness of a VA facility’s HRPP
- Continuing non-compliance is a persistent failure to adhere to the laws, regulations, or policies governing human research
Guidance and Reporting Timelines for Reportable Events (table format - very helpful for at-a-glance reference)
Research Information Incidents Policy (for unauthorized disclosures of participant information)