Glossaries
Glossaries
| Term | Definition |
|---|---|
| ontology |
An explicit formal specification of how to represent relationships among objects, concepts, and other entities that belong to a particular domain of experience or knowledge. See also terminology.
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| official protocol title |
The formal descriptive name for the protocol sufficient to describe key elements of the study, aimed at a scientific audience. NOTE: The official protocol title should include the study acronym, if applicable [After WHO ICTRP]. The official protocol title should be sufficiently different from other official protocol titles to create brevity with specificity [NIH Protocol Template]. In the case of a master protocol, the study title may be more specific than the protocol title. See also protocol title, public protocol title.
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scientific protocol title |
| observer-reported outcome (ObsRO) |
A type of clinical outcome assessment. A measurement based on a report of observable signs, events or behaviors related to a patient's health condition by someone other than the patient or a health professional. [After BEST Resource]
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| observer assessment |
An assessment of patient condition made by an observer (investigator, nurse, clinician, family member, etc.). NOTE: Distinguished from self-assessment. The observer relies on his or her judgment to assess the subject. an interviewer simply capturing subject self assessments is not making an observer assessment. Compare to PRO, proxy assessment.
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| observational study |
A non-interventional study in which the researchers observe the effect of a risk factor (e.g., exposure), diagnostic test, treatment or other covariate, within a study population, and where the independent variable is not under the control of the researcher. NOTE: Major subtypes of observational studies are cohort study, case-control study, and cross-sectional study. [After Observational studies: Cohort and Case-Control Studies, JW Song, KC Chung Plast Reconstru Surg, 2010 Dec; After A Dictionary of Epidemiology (5th ed.), Porta M, ed. (2014)., Oxford University Press, New York; www.strobe-statement.org] See also cohort study, case-control study, cross-sectional study. Compare to interventional clinical trial.
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| observation |
An assessment of patient condition in data collected on an individual patient or group of patients. Note: In SDTM, an observation refers to a discrete piece of information collected during a study, e.g., measures used to assess an outcome. [SDTM] See also variable, outcome.
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| objective |
The reason for performing a study in terms of the scientific questions to be answered by the analysis of data collected during the study. [After ICH E8] See also primary objective, secondary objective.
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| Nuremberg Code |
A code of ethics set forth in 1947 for the conduct of medical research, with the express purpose of protecting human medical research subjects.
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| null hypothesis |
The assertion that no true association or difference in the study outcome or comparison of interest between comparison groups exists in the larger population from which the study samples are obtained. NOTE: A null hypothesis (for example, "subjects will experience no change in blood pressure as a result of administration of the test product") is used to rule out every possibility except the one the researcher is trying to prove, and is used because most statistical methods are less able to prove something true than to provide strong evidence that it is false. The assertion that no true association or difference in the study outcome or comparison of interest between comparison groups exists in the larger population from which the study samples are obtained. See also research hypothesis. [from AMA Manual of Style]
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| Notified Body (NB) |
A private institution charged by the Competent Authority with verifying compliance of medical devices (not drugs) with the applicable Essential Requirements stated in the Medical Device Directive. This process, called Conformity Assessment, has EU-wide validity once completed by the NB.
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| not approvable letter |
An official communication from FDA to inform a sponsor of a marketing application that the important deficiencies described in the letter preclude approval unless corrected.
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| nonclinical study |
Biomedical studies not performed on human subjects. [ICH E6 (R2)]
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| non-interventional study |
A study where the medicinal product(s) is (are) prescribed in the usual manner in accordance with the terms of the marketing authorization. The assignment of the patient to a particular therapeutic strategy is not decided in advance by a trial protocol but falls within current practice and the prescription of the medicine is clearly separated from the decision to include the patient in the study. No additional diagnostic or monitoring procedures shall be applied to the patients and epidemiological methods shall be used for the analysis of collected data. [Clinical Trial Directive EC/20/2001 definitions]
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| non-inferiority (NI) trial |
A type of controlled trial to demonstrate that the new treatment is not less effective than the active control by a specified amount. [After Non-Inferiority Clinical Trials to Establish Effectiveness. FDA Guidance for Industry. November 2016]
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| non-confirmatory result |
In a trial, typically phase 3, results that fail to achieve statistical significance and therefore fail to confirm the preliminary evidence from other trials that a drug is safe and effective for use for the intended indication and population. NOTE: Non-confirmatory trial results provide useful scientific information. [After ICH E8] See also confirmatory trial.
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