XThere are two items that need to be reported within 24 hours:

• Any protocol deviation that was made in order to eliminate an apparent immediate hazard to a participant(s).
• Breach of confidentiality

XFor adverse events that don't involve devices, a harm is unexpected when its specificity and severity are not accurately reflected in the WCMC consent document, Investigator's Brochure (if applicable), or package insert (if applicable).

For devices, a harm is considered unexpected if it was not previously identified in nature, severity, or degree of incidence in the investigational plan or IDE application (including a supplementary plan or application).

XIf the PI or any committee determines that the Immediate Report requires an amendment to the protocol or consent, the PI has 21 days from the date of making the Immediate Report to submit a protocol amendment to the IRB. If this requirement cannot be met, a request for an extension must be made.

XWhen you receive more information about the adverse event and that additional event information continues to meet the reporting criteria for an Immediate Report, a follow-up report should be sent. Indicate in the description of the Immediate Report adverse event that it is a follow-up to the original submission and include both the original and follow-up information in the description of the event.

XNo, you do not need to send your response to both committees. Only send your response to the committee that requested the additional information.

XIf the information doesn't meet Immediate Reporting criteria, the information should be sent to the IRB as an acknowledgment as opposed to an Immediate Report. This will allow the IRB and other committees to focus on capturing and routing emergent risk information most effectively.

XIf using the WCMC DSMB, you will be asked to submit an Adverse Event & IND Safety Report Cumulative Table for each study arm. You will also be asked to provide narratives for all serious adverse events and significant medical events under the Adverse Event Narrative Reporting Requirement. Refer to the WCMC DSMB Periodic Review Form, or email dsmb@med.cornell.edu.

XIf your study is a human gene transfer study, you will be required to submit to the IBC your last annual report to NIH-OBA (refer to the NIH Guidelines for Use of Recombinant DNA Molecules, Appendix M-I-C-3) under the IBC's Human Gene Transfer Annual Reporting Requirement at the time of IRB Continuing Review. For additional information, refer to the IBC website, or email ibc@med.cornell.edu.