Glossaries
Glossaries
| Term | Definition |
|---|---|
| pairing |
A method by which subjects are selected so that two subjects with similar characteristics (for example, weight, smoking habits) are assigned to a set, but one receives Treatment A and the other receives Treatment B. See also matched-pair design.
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matching |
| packaging |
The material, both physical and informational, that contains or accompanies a marketed or investigational therapeutic agent once it is fully prepared for release to patients and/or subjects in clinical trials
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| p-value |
The probability that the observed data could have arisen by chance when the interventions did not differ. [After AMA Manual of Style] See also null hypothesis.
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| overdose |
Administration of a quantity of a medicinal product given per administration or cumulatively, which is above the maximum recommended dose according to the authorised product information. [After, EU Guideline on good pharmacovigilance practices (GVP)]
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| outliers |
Values outside of an expected range.
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| outcomes research |
Research concerned with benefits, financial costs, healthcare system usage, risks, and quality of life as well as their relation to therapeutic interventions. NOTE: Usually distinguished from research conducted solely to determine efficacy and safety. [Guyatt et al., 1993] See also pharmacoeconomics, quality of life.
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| outcome measure |
Specific key measurement(s) or observation(s) used to determine the effect of experimental variables on the participants in a study, or for observational studies, to describe patterns of diseases or traits or associations with exposures, risk factors or treatment. (After BRIDG)
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| outcome (of adverse event) |
Refers to the resolution of an adverse event. NOTE: often denoted using a pick list from a controlled terminology such as: Recovered/resolved, recovering/ resolving, not recovered/not resolved, recovered/resolved with sequelae, fatal, or unknown. [SDTM events class of observation]
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| outcome |
The measureable characteristic (clinical outcome assessment, biomarker) that is influenced or affected by an individual's baseline state or an intervention, as in a clinical trial or other exposure. NOTE: Outcome can be a result of analysis and is more general than endpoint in that it does not necessarily relate to a planned objective of the study outcome (SDTM). [After BEST Resource] See also variable, observation.
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| other serious (important medical events) |
A category of important medical events that may not be immediately life-threatening, result in death, or hospitalization, but may jeopardize the patient or may require intervention to prevent one of the outcomes criteria events requiring assessment for potential regulatory reporting as a serious adverse event. Note: These "Other serious" events require medical and scientific judgement in evaluating the need for reporting as a serious adverse event. Examples include allergic bronchospasm (a serious problem with breathing) requiring treatment in an emergency room, serious blood dyscrasias (blood disorders) or seizures/convulsions that do not result in hospitalization. The development of drug dependence or drug abuse would also be examples of important medical events. [after FDA 310.305, ICH E2A] See also serious adverse event.
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| original data |
The first recorded study data values. NOTE: FDA is allowing original documents and the original data recorded on those documents to be replaced by copies provided that the copies have been verified as identical in content and meaning. (see FDA Compliance Policy Guide 7150.13). [Modified from CSUICI] See also certified copy, source.
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| opinion (in relation to independent ethics committee) |
The judgment and/or the advice provided by an independent ethics committee. [ICH E6 Glossary]
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| operational model |
The set of CDISC data standards (including ODM and LAB) used to capture and archive data from clinical trials.
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| open-label study |
A trial in which subjects and investigators know which product each subject is receiving; opposite of a blinded or double-blind study. See blinding.
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| open to enrollment |
The status of a study such that a subject can be enrolled into that study. NOTE: Registry terminology in common use is "open to recruitment"; however, recruitment can begin upon IRB approval of the site; whereas enrollment requires availability of study supplies, subject informed consent, etc., to allow participation of eligible subjects.
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