Guidance for Reportable Events

The Principal Investigator should promptly report to the North Texas Regional IRB a protocol deviation or violation within 10 business days of when the event was discovered. The report should describe the event and the PI’s risk assessment of the event (including the rationale for their assessment). Additionally, a corrective plan or solution for preventing such an event from occurring again should be included in the report. Researchers can provide the IRB with all the necessary information by either completing and submitting the Protocol Deviation / Violation Form located on the NTR IRB Forms webpage, or submitting a signed memo by the Principal Investigator, containing the aforementioned information.

Please note that protocol deviations or violations are reported to the convened board regardless of the type of review under which the project was originally approved. Board findings, if any, or notifications will be sent to the Principal investigator.

For more guidance on this topic, please click here. This guidance document covers the definition of a “protocol violation/deviation”, provides examples, how to report to the IRB, and how to avoid such events from occurring.

Additionally, you may visit “Defining Protocol Violations”. This manual is a lexicon created by Norman Goldfab, Chairman of the PDV Code Governing Committee for understanding and communicating protocol deviations and violations. This document also provides some examples of protocol violations and deviations within human subject research.  Please contact the North Texas Regional IRB for any additional guidance on how to report protocol violations.

The Principal Investigator should promptly report to the North Texas Regional IRB an SAE that occurred for a study participant, within 10 business days of notification of the event. Please note that both on-site (internal events/SAEs occurring for study participants enrolled under a NTR IRB affiliate) and off-site (external events/SAEs occurring for the same study, but for study participants enrolled by a different study site, or non-NTR IRB affiliate) will need to be reported to the NTR IRB. Forms for both On-Site and Off-Site SAEs are available on the NTR IRB website, and below:

SAE Form – ON-SITE

SAE Form – OFF-SITE

NOTE: If the event resulted in death (regardless of whether the event is initially assessed as related to the study), ol, a message must be sent via the electronic submission system (using Project Mail) within 24 hours of notification of the event.  This e-mail must contain the following information: 

• IRB Project #
• Principal Investigator
• Project Title
• Subject’s Initials, Gender and Age
• Date and Time of Event
• Brief Description of Event
• Investigator’s Initial Assessment of Relationship of SAE (death) to the Study

For additional guidance, please visit:

SAE Guidance: This information provides investigators with guidance on how and when to report an on-site SAE for a particular study. You must have pdf capabilities to access this document or you may visit the link “SAE Guidance” for more information.