Glossaries
Glossaries
| Term | Definition |
|---|---|
| enrollment (cumulative) |
Current enrollment including any subjects who were once enrolled and have ended participation.
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| enrollment |
The action of enrolling one or more subjects. NOTE: The subject will have met the inclusion/exclusion criteria to participate in the trial and will have signed an informed consent form. [After Glossary Of Terms On Clinical Trials For Patient Engagement Advisory Committee Meeting] See also enrolled.
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| enrolled |
Status assigned to a subject who agrees to participate in a study, following completion of the informed consent process and meeting eligibility criteria as specified in the protocol. NOTE: Enrollment routinely requires verification of eligibility and inclusion in the analysis database. A less common definition confers enrolled status at the signing of an informed consent form, e.g., Clinicaltrials.gov. See also informed consent, enrollment.
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| endpoint |
A defined variable intended to reflect an outcome of interest to address a particular research question. NOTE: A precise definition of an endpoint typically specifies the type of assessments made, the timing of those assessments, the assessment tools used, and possibly other details, as applicable, such as how multiple assessments within an individual are to be combined. Primary endpoints are usually statistically analyzed. [After BEST Resource] See also outcome, variable, surrogate endpoint.
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| endemic disease |
The constant presence of a disease or infectious agent within a given geographic area or population group; may also refer to the usual prevalence of a given disease within such area or group. [A dictionary of epidemiology, edited for the International Epidemiological Association by John M. Last, Oxford University Press 2001]
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| end-point assessment medicinal product |
Medicinal products given to the subject as an aid to assess a relevant clinical trial end-point; it is not being tested or used as a reference in the clinical trial. [After Recommendations from the expert group on clinical trials for the implementation of Regulation (EU) No 536/2014' dd 28 June 2017]
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| EMR (electronic medical record) |
An electronic record for healthcare providers within one healthcare organization to create, store, and use clinical information for patient care. An electronic record derived from a computerized system used primarily for delivering patient care in a clinical setting. NOTE: EMRs (or EHRs) may serve as source documents, and such data could serve also as source data for clinical trials provided that the controls on the EMR system and the transfer of such data to the eClinical trial system were to fulfill regulatory requirements (e.g., 21 CFR 11). [After Guidance for Industry, Use of Electronic Health Record Data in Clinical Investigations, July 2018]
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| emergency use authorization |
Approval by FDA for the emergency use of certain unapproved medical products or an unapproved use of an approved medical product for certain emergency circumstances, when applied for under a declared health emergency. These medical products may be referred to as medical countermeasures (MCMs) and may include drugs, biologics, and devices. [After Emergency Use Authorization of Medical Products and Related Authorities. FDA Guidance for Industry and Other Stakeholders. January 2017.] See also pre-approval access.
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EUA |
| eligibility criteria |
Requirements that must be met for a person to be included in a study, which help make sure that the results of the study are caused by the intervention being tested and not by other factors. NOTE: Eligibility Criteria, including inclusion and exclusion criteria, should enable constitution of the targeted cohorts in the clinical study. [After NCI's Dictionary of Cancer Terms]
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| electronic signature |
A computer data compilation of any symbol or series of symbols, executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual's handwritten signature. [CSUICI; 21 CFR 11.3(7)]
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eSignature |
| electronic record |
Any combination of text, graphics, data, audio, pictorial, or other information representation in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system. [21 CFR 11.3(b) (6)]
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| electronic personal health record (ePHR) |
An electronic record for individuals to create, import, store, and use clinical information to support their own health.
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| EHR (electronic health record) |
An electronic record for healthcare providers to create, import, store, and use clinical information for patient care, according to nationally recognized interoperability standards. NOTE: The EHR has the following distinguishing features: able to be obtained from multiple sources; shareable; interoperable; accessible to authorized parties. [After National Office of Health Information Technology-HIT, USHHS]
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| efficacy |
A measure of intended effect on the disease or condition based on adequate and well-controlled clinical trials. [After Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products. FDA GUIDANCE DOCUMENT. MAY 1998. After Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products. FDA Guidance for Industry (DRAFT GUIDANCE). December 2019] See also effectiveness.
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| effectiveness |
A measure of intended effect on the disease or condition based on regulatory determination made on the basis of clinical efficacy and other substantial evidence, including real-world observations. [After Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products. FDA GUIDANCE DOCUMENT. MAY 1998. After Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products. FDA Guidance for Industry (DRAFT GUIDANCE). December 2019] See also efficacy.
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