Human Research Protections Program Immediate Reporting Policy
|Immediate Report Forms|
|Immediate Reporting Policy||Adobe PDF|
|Immediate Reporting Form||Microsoft Word|
|Adverse Event & IND Safety Reporting Cumulative Table||Microsoft Word|
|Protocol Deviations Guide||Webpage|
24 Hour Reporting Quick Guide
|Report Within 24 Hours|
|Any protocol deviation that was made in order to eliminate an apparent immediate hazard to a participant.|
|Breach of confidentiality|
Immediate Reporting FAQ:
Which incidents and information need to be reported within 24 hours?
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
- When is a harm considered "unexpected"?
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).
- What if an amendment is needed?
XIf the PI or any committee/board determines that the Immediate Report requires an amendment to the protocol or consent, the PI has 30 days from the date of making the Immediate Report (or release of the sponsor amendment) to submit a protocol amendment to the IRB. If this requirement cannot be met, a request for an extension must be made.
- For Immediate Reports that are adverse events, does follow-up need to be submitted?
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.
- What if the policy requires me to submit an Immediate Report to more than one committee (the IRB and the WCMC DSMB, for example) and only the WCMC DSMB has follow-up questions about the Immediate Report, but not the IRB? Do I have to send my follow-up response to both committees?
XNo, you do not need to send your response to both committees. Only send your response to the committee that requested the additional information.
- What if the study sponsor requires the submission of an adverse event, deviation or other type of information that doesn't meet the criteria for an Immediate Report?
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.
- What other adverse events, incidents and information will I need to report to the WCMC DSMB for Periodic Review?
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 firstname.lastname@example.org.
- What other adverse events, incidents and information will I need to report to the WCMC IBC for the Annual Human Gene Transfer Reporting Requirement?
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 email@example.com.
As you are aware, certain adverse events and incidents must be immediately reported to NYPH Patient Services, Risk Management, and/or the Department of Health. Please refer to the following policies/offices to determine whether this event qualifies for reporting to any of the aforementioned groups.
NYPH-WCMC Patient Services
NYPH-WCMC Westchester Patient Services