Prompt reports should be submitted as RNIs by completing the Reportable Adverse Event Form and uploading the PDF of the form in the eIRB system along with any required supporting documentation. Supporting documentation to upload in eIRB with the Adverse Event form includes:

• For internal events, include notes from the EMR and reports to the sponsor (redacted to remove identifiers)
• For external events, include the sponsor's determination that demonstrates reportability.

Reporting Time Frames for reporting to the IRB

1) Adverse Events

1. Internal problems must be reported within 5 working days.
2. External problems must be reported within 20 working days.

2) Deaths

1. Report by email to IRBhelp@kumc.edu within 24 hours of the PI or research team becoming aware of the adverse event; and,
2. Submit an RNI written report to the IRB within 5 working days.

Prompt reporting (within 5 working days of the study team's awareness) is ALWAYS required in the following circumstances:

1. Failure to obtain informed consent or re-consent when required by the IRB
2. Modifying the protocol without IRB approval, except to avoid immediate hazard to participants
3. Conducting the research before IRB approval, during an IRB suspension, or after IRB approval expires.

Additionally, prompt reporting is required for other noncompliance when the principal investigator (PI) determines the noncompliance meets at least one of the following criteria:

1. Causes harm or increases the risk of harm;
2. Adversely affects the rights and welfare of the participants; OR
3. Undermines the scientific integrity of the data

Prompt reports should be submitted as RNIs by completing the NonCompliance Reporting Form and uploading the PDF of the form with any supporting documentation (as necessary) in eIRB.

Documentation of all incidents of noncompliance, both reportable and non-reportable, must be maintained by the study team throughout the life of the study. To document noncompliance that does not require prompt reporting, study teams can use various sources including:

• Investigator-signed NonCompliance Reporting Form PDF
• NonCompliance Log
• Other means supplied by the sponsor or developed by individual study teams, provided the documentation shows the principal investigator's assessment of the event

KUMC investigators may request prospective approval of a one-time exception to the IRB-approved study protocol. These planned, non-emergent exceptions may include, but are not limited to:

• Exceptions to eligibility criteria
• Exceptions to the form or manner of obtaining informed consent
• Use of out-of-window test results
• Exceptions to the administration or use of an investigational product

One-time exception request should be submitted as an RNI by completing the Exception Request Form and uploading the PDF of the form with any supporting documentation in eIRB. Requests for studies with external sponsors must include the sponsor's approval for the exception.

At the time of submission, please also send an email to IRBhelp@kumc.edu to ensure prompt review. One-time exceptions must be uploaded and approved by the IRB in advance of change implementation so please allow at least one business day for IRB review.

Please Note: Exception requests for studies under an external IRB should be submitted to the external IRB according to their policies and requirements.

For permanent changes to the protocol, please submit the request (to the KUMC IRB or to the external IRB) as a study modification.