Adverse Event Report

Reporting requirement — IRB Protocol PPRN-001-2025

All adverse events must be reported to the IRB within 24 hours of occurrence. Serious adverse events (SAEs) require immediate phone notification to the PI. Reports are reviewed by: M. Scott Mortensen MD (PI), Dr. Shariar Cohen MD, Dr. Sunil Kurup MD, and Dr. Barbara Krutchkoff PhD. All reports are confidential and de-identified before entering the research registry.

Reporting Provider

Provider Name *

License Number *

Email *

Phone

Practice Name

Patient (De-identified)

Patient Initials *

Date of Birth (MM/YYYY)

Sex

Age at Event

Event Details

Date of Event *

Date of Report *

Severity *

1Mild

2Moderate

3Severe

4SAE

Suspect Compound(s) *

Adverse Event Description *

Relevant Medical History / Concurrent Medications

Action Taken

Compound discontinued Dose reduced Patient referred to ER / hospital Supportive treatment provided No action required — monitoring

Outcome

Causality Assessment

Additional Notes / Recommendations

📋 Copy for EMR / IRB Records

Fill out the form above — your formatted adverse event report will appear here for copy/paste into your EMR or IRB records.

✓ Report submitted

Your adverse event report has been received by the ONZEN IRB team. You will receive acknowledgment within 24 hours. For Severity 4 (SAE), please also call the PI directly. Keep a copy of this report in the patient chart.

IRB PI: M. Scott Mortensen MD · Mortensen Medical · 101 Hodencamp Rd Ste 103, Thousand Oaks CA 91360