INTERNAL DEATH REPORT

version February 2025

POLICY: All internal deaths (regardless of attribution) MUST be reported to the IRB within 10 working days of the study team's knowledge of the event. An internal event represents an event that happened to a subject who was enrolled at a Piedmont Healthcare site and for which Piedmont Healthcare IRB is the IRB of record.


Deaths must be reported as INDEPENDENT events (not in conjunction with an adverse event) using this form. Attach all relevant/supporting documents along with the consent version in effect at time of event.

Please enter the email contact for an individual knowledgeable about this report.

Use MM/DD/YYYY format

Date of this report

Use MM/DD/YYYY format

Date of event (death)

Use MM/DD/YYYY format

Enter date team member is made aware of event

Use MM/DD/YYYY format

Relationship to study participation*

By selecting 'unknown' you attest that no other clarifying information can be obtained.

Event expectation*
Event causality*

If the death was unexpected AND related OR possibly related to participation in the study, does the death suggest that the research places others at a greater risk of harm than was previously known or recognized?

Please provide details and any safety measures to be put into place to protect subjects going forward.

a. Use lay language to fully describe the circumstances of the death.

b. Submit de-identified documentation pertaining to the death. Include a death certificate and/or obituary when possible.

c. Do not hold report past the 10 working days of knowledge of event. If this report is awaiting medical records or other documentation for completion beyond the mentioned time period, please add that your narrative below and indicate that follow up documentation on the event will be forthcoming.

Event reporting*

Indicate whether the event has been reported to the sponsor and/or FDA

Affect on ICD*

Indicate whether changes to the informed consent document are needed due to this event.

Submit a revised informed consent document to the IRB (separately) using the Request for Modification form found at https://www.piedmont.org/research/research-eforms-and-systems.

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