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Toxicity

An adverse effect produced by a drug that is detrimental to the participant's health. The level of toxicity associated with a drug will vary depending on the condition which the drug is used to treat.

TPC

Tissue Procurement Core

Treatment and Parallel Track INDs

Investigational new drugs may be made available outside of a clinical trial, through a treatment protocol, to multiple patients with life-threatening or other serious diseases for which no satisfactory alternative drug or other therapy exists.

Treatment IND

IND stands for Investigational New Drug application, which is part of the process to get approval from the FDA for marketing a new prescription drug in the US. It makes promising new drugs available to desperately ill participants as early in the drug development process as possible. Treatment INDs are made available to participants before general marketing begins, typically during Phase III studies. To be considered for a treatment IND a participant cannot be eligible to be in the definitive clinical trial.

Trial design

Some Phase II trials are designed as case series, demonstrating a drug's safety and activity in a selected group of patients. Other Phase II trials are designed as randomized clinical trials, where some patients receive the drug/device and others receive placebo/standard treatment. Randomized Phase II trials have far fewer patients than randomized Phase III trials.

UM Event

An event which occurs in a study under the supervision of the UM IRBMED and whose PI is a UM faculty or staff member. The event is a UM Event when it occurs at UM (including any UM hospital, health center, or other facility) or any other site where the UM PI has oversight, even when the PI is physically in another location. It does not matter where the subject experiences or is treated for the Adverse Event. If interventions take place at different UM locations (e.g., the Michigan Clinical Research Unit {MCRU}), please specify at which location the event occurred.

UMHHC

University of Michigan Hospitals and Health Centers

UMHS

University of Michigan Health System, now known as Michigan Medicine

UMMS

University of Michigan Medical School

Unanticipated

An event is when "unanticipated" when it was unforeseeable at the time of its occurrence. Unanticipated and Unexpected are not synonymous. A research protocol can monitor for an unexpected event, but cannot monitor for an unforeseen event. All unanticipated events are unexpected but not vice versa.

Unanticipated Problem Involving Risks to Subjects or Others (UPIRSO / UaP)

Often referred as an Unanticipated Problem. An unanticipated problem may be either an actual harmful or unfavorable occurrence or any development that potentially increased the likelihood of harm occurring in the future. Assessment Criteria:                                  

  1. Unanticipated Severity:  The nature, severity, or frequency of the event(s) or information was NOT expected, given descriptions in the study documents or the characteristics of the subject population being studied.
  2. Related:  There is a reasonable possibility that the procedures involved in the research caused the problem.
  3. Increased Risk:  The event(s) or information suggests that the research places subjects or others at a greater risk of harm than was previously known or recognized (including physical, psychological, economic, or social harm).

Unapproved Medical Device

A device used for a purpose or condition for which the device would require but does not have pre-market approval or an approved investigational device exemption (IDE) from FDA.

Underlying condition

A disease or other circumstance affecting the research subject that is not a result of the intervention or experimental design of a research study.

Undue Influence

Excessive or inappropriate reward or other incentive in which a person is induced to act otherwise than by their own free will or without adequate consideration of the consequences.

Unexpected

Not identified by nature, severity or frequency in the current University IRB-approved research protocol or informed consent document

Unexpected Adverse Drug Reaction

A term used by some sponsors to refer to an adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g., Investigator's Brochures for an unapproved investigational product or package insert/summary of product characteristics for an approved product).

Unexpected Adverse Event

Any adverse event occurring in one or more subjects in a research protocol, the nature, severity, or frequency of which is not consistent with either:                                  

  1. the known or foreseeable risk of AEs associated with the procedures involved in the research that are described in (a) the IRB-approved documents (e.g., applicable investigator brochure, current protocol narrative, current informed consent document), and (b) other relevant sources of information, such as product labeling and package inserts; or
  2. the expected natural progression of any underlying disease, disorder, or condition of the subject(s) experiencing the AE and the subject’s predisposing risk factor profile for the AE.

Unexpected Magnitude, Duration or Frequency

An event or occurrence(s) should be reported to the IRBMED according to the Timeline for unexpected events when the intensity (severity), how long the event takes or persists, or the rate of occurrence is different than described in the informed consent document (ICD), even if the event is otherwise described in the ICD. For example, the ICD notes that some subjects experience mild, brief ringing in the ears following an fMRI. If a subject experiences ringing of significant intensity (such that she cannot work or attend classes) or the ringing persists for several weeks, the event would be reportable as an unexpected event. Likewise, if elevated liver enzymes were described in the ICD as expected at statistical rate of 2% but monitoring revealed 10% of subjects experienced such elevations, this should be reported as an unexpected adverse event.

University

University or UM is the University of Michigan

Unlikely related adverse event

An adverse event that         

  • is NOT a previously known or suspected effect of the test drug, device, or procedure
  • does NOT follow a sequence of time from drug administration, device implantation and/or activation, or procedure, for which the event could be attributed to the administration, implantation, activation, or procedure
  • can be readily explained by the characteristics of the population under study

Unrelated

Unassociated or without a timely relationship; evidence exists that an outcome is definitely related to a cause other than the event in question.

Unrelated adverse event

An adverse event that         

  • is NOT known to be an effect of the test drug, device, or procedure
  • does NOT follow a sequence of time from drug administration, device implantation and/or activation, or procedure, for which the event could be attributed to the administration, implantation, activation, or procedure
  • can be readily and easily explained by the characteristics of the population under study
  • involves a subject who never received study drug, study device, or underwent research study procedure

 See also CauseRelatedness.

VA

Veteran’s Affairs

Viable

As it pertains to a neonate, able to survive after delivery to the point of independently maintaining heartbeat and respiration. The Secretary may, from time to time, take in account medical advances and publish in the Federal Register guidelines to assist in determining whether a neonate is viable for purposes of 45 CFR 46. If a neonate is viable, then it may be included in research only to the extent permitted and in accordance with the requirements of 45 CFR 46.

Violation

Accidental or unintentional changes to or noncompliance with the IRB approved protocol that affects the subject's rights, safety, welfare, and/or the integrity of the data.

Voluntary

Free of coercion, duress, or undue inducement. Used in the research context to refer to a subject's decision to participate (or to continue to participate) in a research activity.

Vulnerable Subjects

Vulnerable populations can be defined as children, prisoners, pregnant women, handicapped or mentally disabled persons, or economically or educationally disadvantaged persons. If vulnerable individuals are involved in clinical trials, IRBs must ensure that additional safeguards have been included to protect the vulnerable group. Safeguards may include the presence of interpreters or social workers to explain the research and ensure informed consent. IRBs have a specific obligation to protect those individuals who are particularly susceptible to coercion or undue influence (21 CFR 56.11). Studies involving vulnerable groups often pose difficult ethical questions. For example, vulnerable subjects may not be allowed to participate in research that involves more than minimal risk but conveys no benefits directly to the subjects. (21 CFR 56.11 and 45 CFR 46 Subparts B, C, D).

Washout Period

Period of time without active treatment, usually scheduled before the beginning of the placebo and active treatment arms. This can refer to a required period of withdrawal from treatment before active treatment starts.

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