REPORT OF UNANTICIPATED PROBLEMS (UPs) AND SERIOUS ADVERSE EVENTS (SAEs)

version February 2025

Unanticipated problems consist of both adverse events that are unanticipated and unanticipated problems that

are not adverse events.


Unanticipated Problem: An unexpected problem that is defined by as any incident, experience, or outcome that 1) is unexpected in terms of nature, severity, or frequency, AND 2) is related or possibly related to participation in the study, AND 3) suggests that the research places the subject or others at a greater risk of harm than was previously known OR criterion #3 alone. NOTE: the PHCIRB expects reports of serious adverse events that are ALSO unanticipated problems and not mere adverse events


Serious Adverse Event: An event that results in death, is life-threatening, requires hospitalization or prolongation of hospitalization, causes persistent or significant disability or incapacity, is a birth defect or congenital malformation, represents (in the PI's judgement) other significant hazards or potentially serious harm to research subjects or others, or any other event as described in the research protocol.


POLICY: In accordance with Piedmont Healthcare Institutional Review Board (PHCIRB) policy # 6421, all unanticipated problems and unanticipated adverse device effects must be reported to the IRB within 10 working days of the study team's knowledge of the adverse event. Relationship/association determinations are based on the study procedures, device, and/or drug. Internal deaths must be reported as INDEPENDENT events and separate from other event reporting via the Internal Death Report Form.

Name, credential, department

Email address of PI or knowledgeable designee

Use MM/DD/YYYY format

Succinctly describe event and attach

supporting de-identified documentation (labs, etc...) to the submission upload.

EVENT CAUSALITY

Respond to each item 1-5 below

1) DEVICE*
2) Disease/condition*
3) Drug*
4) Procedures*
5) Other, explain below*
EVENT DETAILS*


*in terms of nature, severity, or frequency


**All research interactions and interventions (inclusive of obtaining identifiable private information) about the

now incarcerated participant MUST cease until the requirements of subpart C have been addressed and satisfied for this protocol. NOTE: the regulations allow for an exception in the circumstance where the PI feels it is in the best interest of the participant to continue in the research while incarcerated and prior to IRB review for

subpart C considerations.

REPORTING CONSIDERATIONS

Event impact*

Does the event suggest that the research places the subject or others at a greater risk than previously known?

Consent *

Are consent form changes required due to this event?

Signature of PI or designee



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