Reporting Important Information to IRB (Reportable New Information)

HRP-224 REPORTABLE NEW INFORMATION FORM – INSTRUCTION GUIDE

The HRP-224 Reportable New Information Form is used to submit new information to the IRB. Page 2 of this form indicates the information items that must be reported to the IRB. Use this form to determine if an information item is reportable to the IRB.

All information must be reported to the IRB within 5 business days of the date the PI became aware of the information.

This form is to be used to report any information listed on page 2 of the form.

Only information that falls under the categories on page 2 must be reported to the IRB.

If any changes to the protocol or consent are required based on the information being reported, HRP-213 (Modification Form) must also be submitted.


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