Tracking Log for Non Reportable Events

Tracking Log for Non-Reportable Events

Researchers are required to submit all reportable events/problems (See list of Reportable Events/Problems) to the IRB via the e-AE/UP reporting process. Protocol Deviations and Safety Reports (external AEs) that do not constitute reportable events do not require submission to the IRB. Researchers may notify the HRP staff of protocol deviations or Safety Reports that do not constitute reportable events, by submitting this form to HRP/OR at 5171 California, Suite 150, Irvine, CA 92617-3067. NOTE: All Non-reportable Safety Reports should be reviewed and dated by the Lead Researcher and maintained with the research documentation.

This form will only be reviewed by the HRP staff. Once confirmed that the event(s) do not constitute reportable event(s), the staff will sign and date the form and return the original to the Lead Researcher. If the HRP staff determines, in consultation with an IRB Chair, that an event is reportable per UCI IRB policy, the researcher will be required to submit an e-AE/UP report.

Lead Researcher: Administrative Contact: LR’s Phone Number: AC’s Phone Number: HS#: Study Title: In the opinion of the Lead Researcher: Did the event involve harm to one or more Type of participants or Was the event at Event: Subject # Was the event others, or placed least possibly Deviation Date of or unexpected? one or more related to the or Safety Brief Description of Deviation/Safety Report Event Reference YES/NO participants or research? Report # others at YES/NO increased risk of (DEV / SR) harm? YES/NO If the answers to the above three questions are ALL yes, you must report this event within 10 working days via the e-AE/UP reporting process. Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No Yes No I have reviewed the deviations and Safety Reports listed above, and determined that they do not constitute reportable events per UCI IRB policy.

______Lead Researcher or Co-Researcher Signature Date

For ORA/HRP use only

HRP Staff Signature Date