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, temporally associated with, but not necessarily considered related to, the subject’s participation in the research study.   Not all adverse events meet IRB reporting guidelines.

Continuing non-compliance: Non-compliance that has been previously reported or a pattern of ongoing non-compliance that, in the judgment of the University IRB, significantly adversely affects the rights and welfare of participants or significantly compromises the quality of the research data (i.e., negatively impacts the ability to draw conclusions from the study data).
External adverse event: An adverse event that occurs at a site external to the authority of the University IRB and is reported to the University or UPMC investigator.

Internal adverse event: An adverse event that occurs at a site that falls directly under the authority of the University IRB.

Non-compliance: Failure on the part of the investigator or any member of the study team to follow the terms of University of Pittsburgh IRB approved protocol or to abide by applicable laws or regulations, or University of Pittsburgh IRB policies. This includes protocol deviations.
 
Incidents of non-compliance on the part of research participants which do not involve risk need not be reported to the IRB.

Possibly Related to the Research Intervention: In the opinion of the principal investigator, there is a reasonable possibility that the incident, experience, 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 or outcome more likely than not was caused by the procedures involved in the research.

Serious Adverse Event or Suspected Adverse Reaction: An adverse event or suspected adverse reaction is considered “serious” if, in the view of either the investigator or sponsor, it results in any of the following outcomes: Death, a life threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/ birth defect.  Important medical events that may not result in death, be life-threatening, or require hospitalization may be considered serious when, based upon appropriate medical judgment, they may jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the outcomes listed in this definition. Examples of such medical events include allergic bronchospasm requiring intensive treatment in an emergency room or at home, blood dyscrasias or convulsions that do not result in inpatient hospitalization, or the development of drug dependency or drug abuse.

Serious non-compliance: Non-compliance that, in the judgment of the University IRB, significantly adversely affects the rights or welfare of participants, or significantly compromises the quality of the research data. Examples of non-compliance that are considered to meet the definition of serious non-compliance include, but are not limited to:

  1. performing non-exempt human subject research without obtaining prospective University IRB approval
  2. implementing substantial modifications to a research study without obtaining prospective University IRB approval
  3. failing to systematically obtain research subjects’ informed consent as required by the IRB approved protocol
  4. failing to comply with federal regulations governing human subject protections (this includes activities of the University IRB and/or University IRB Office staff)

Unanticipated: Unforeseeable at the time of its occurrence.
 
Unanticipated Problem Involving Risks to Human Subjects or Others: Any accident, experience, or outcome that meets all of the following criteria:

  1. Unexpected in terms of nature, severity, or frequency;
  2. Related, or possibly related, to a subject’s participation in the research;
  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, safety or any life-threatening problem or death cause by, or associated with, a  device, if that effect, or problem, or death was not previously identified in nature, severity or degree of incidence 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: Not identified by nature, severity or frequency in the investigator’s brochure, sponsor protocol or current University IRB-approved research protocol or informed consent document, taking into account the characteristics of the subject population being studied.