Reportable Event Definitions

Definitions

Adverse Event: An unfavorable medical occurrence, which may include abnormal signs (for example, abnormal physical exam or laboratory finding), symptoms, or disease, that is temporally associated with, but not necessarily considered related to, the subject’s participation in the research study.

Continuing Non-compliance: Non-compliance that has been previously reported or a pattern of ongoing Non-compliance that, in the judgment of the IRB, significantly adversely affects the safety, rights or welfare of human research subjects or others, significantly compromises the quality or integrity of the research data (i.e., negatively impacts the ability to draw conclusions from the study data), or significantly negatively affects the integrity of the HRPP.

External Adverse Event: An Adverse Event that occurs at a site external to the authority of the University IRB.

Internal Adverse Event: An Adverse Event that occurs at an University of Pittsburgh or UPMC site that falls directly under the authority of the University IRB.

Non-compliance: Failure on the part of the Principal Investigator or any member of the study team to follow the terms of the IRB approved protocol or to abide by applicable laws, regulations, or HRP policies.

Possibly Related to the Research Intervention:  In the opinion of the Principal Investigator, there is a reasonable possibility that the incident, experience, new information or outcome may have been caused by the procedures involved in the research. Probably Related to the Research Intervention:  In the opinion of the Principal Investigator, the incident, experience, new information or outcome more likely than not was caused by the procedures involved in the research.

Serious Adverse Event: A serious adverse event (SAE) is an untoward occurrence, whether or not considered related to a participant’ participation in research, that results in death, a life-threatening experience, inpatient hospitalization, prolongation of hospitalization, persistent or significant disability or incapacity, congenital anomaly or birth defect, or that requires medical, surgical, behavioral, social, or other intervention to prevent such an outcome.

Serious Non-compliance: Non-compliance that, in the judgment of the IRB, significantly adversely affects the safety, rights or welfare of human research subjects or others, significantly compromises the quality or integrity of the research data (i.e., negatively impacts the ability to draw conclusions from the study data), or significantly negatively affects the integrity of HRPP.

Unanticipated: Unforeseeable at the time of its occurrence.  

Unanticipated Problem Involving Risk to Human Subjects or Others: Any accident, experience, new information or outcome that meets all of the following criteria:

1. Unexpected in terms of nature, severity, or frequency;
2. Related, or possibly related, to research activities; and
3. Places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized.

Unanticipated Adverse Device Effect: Any serious adverse effect on health or safety, life-threatening problem, or death caused by, or associated with, a device that was not previously identified in nature, severity or frequency in the investigational plan or application (including a supplementary plan or application), or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects.

Unexpected Adverse Event: An Adverse Event that was not previously identified in nature, severity, or frequency in the investigator’s brochure or equivalent product information, sponsor protocol or current IRB-approved research protocol or informed consent document, taking into account the characteristics of the subject population being studied.

8/25/2025