ACORI | Dictionary: $U

Umbrella Protocol

An umbrella protocol is a type of master protocol designed to evaluate multiple investigational medicines administered as single medicines or as medicine combinations in a single disease population. (CDISC)

Unanticipated Adverse Device Effects

Unanticipated adverse device effects are any serious adverse effect on health or safety or any life-threatening problem or death caused by (or associated with) a device. It only applies if that effect, 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). It also includes any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of participants. (NIH)

Unanticipated Problems

Unanticipated problems involve risks to study participants or others, which are unexpected in terms of nature, severity, or frequency and related or possibly related to participation in the research in that the study. This includes placing participants or others at a greater risk of harm (e.g., physical, psychological, economic, social harm) than was previously known or recognized.

Unblinding

In some clinical studies, participants (or both participants and investigators) are not aware of which participants received which treatments. Unblinding is when this information is revealed. This often happens after a study has concluded (as outlined in the study design) or for safety reasons.

Unexpected Adverse Drug Reaction

An unexpected adverse drug reaction is an adverse medicine reaction whose nature, severity, specificity, or outcome is not consistent with the terms or descriptions used in the applicable product information. (CDISC)

Unexpected Serious Adverse Event

An unexpected serious adverse event is a serious adverse experience that is not listed in the labeling of a health product. These usually require rapid reporting to the study sponsor and the Food and Drug Administration.

Unexpected Serious Risk

An unexpected serious risk is the risk of a serious adverse experience that is not listed in the labeling of a health product. These usually require rapid reporting to the study sponsor and the Food and Drug Administration.

Unmasking

In some clinical studies, participants (or both participants and investigators) are not aware of which participants received which treatments. Unmasking is when this information is revealed. This often happens after a study has concluded (as outlined in the study design) or for safety reasons.

Unrestricted Access

Unrestricted access means that anyone can see and/or use information gathered from a clinical study.

Clinical Research Terms Glossary

Terms starting with U