Glossaries
Glossaries
| Term | Definition |
|---|---|
| hypothesis to test |
In a trial, a statement relating to the possible different effect of the interventions on an outcome. The null hypothesis of no such effect is amenable to explicit statistical evaluation by a hypothesis test, which generates a P value. [CONSORT Statement]
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| HyperText Markup Language (HTML) |
A specification of the W3C that provides markup of documents for display in a web browser. [HL7] Contrast to XML.
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| hypertext |
Links in a document that permit browsers to jump immediately to another document. NOTE: In most browsers links are displayed as colored, underlined text.
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| Huriet Law |
France's regulations covering the initiation and conduct of clinical trials.
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| human subject |
Individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy human or a patient. [21 CFR 50.3]. See also clinical research subject.
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subject/trial subject |
| HIE (Health Information Exchange) |
The mobilization of healthcare information electronically across organizations within a region or community. HIE provides the capability to electronically move clinical information between disparate healthcare information systems, while maintaining the meaning of the information being exchanged. The goal of HIE is to facilitate access to, and retrieval of, clinical data to provide safer, more timely, efficient, effective, equitable, and patient-centered care. [HITSP]
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| healthy volunteer |
A healthy person volunteering to participate as a subject in a clinical study. NOTE: This is often a healthy person agreeing to participate in a Phase 1 trial. See also Phase 1. [After Patient Recruitment Healthy Volunteer, NIH Clinical Center, 05/18/2022, Webpage accessed 03/30/2023]
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| healthcare provider |
A person licensed, certified, or otherwise authorized or permitted by law to administer healthcare in the ordinary course of business or practice of a profession, including a healthcare facility. [HL7]
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| health-related quality of life (HRQoL) |
A multi-domain concept that represents the patient's general perception of the effect of illness and treatment on physical, psychological, and social aspects of life. NOTE: Claiming a statistical and meaningful improvement in HRQoL implies: (1) that all HRQoL domains that are important to interpreting change in how the clinical trial's population feels or functions as a result of the targeted disease and its treatment were measured; (2) that a general improvement was demonstrated; and (3) that no decrement was demonstrated in any domain. [FDA Clinical Outcome Assessment (COA) Glossary] Compare to quality of life (QoL).
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| health literacy |
The degree to which an individual has the capacity to obtain, communicate, process, and understand basic health information and services to make health decisions. [After The Patient Protection and Affordable Care Act of 2010, Title V; After What is Health Literacy? Oct 23, 2019]. See also plain language writing.
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| Health Level 7 (HL7) |
An ANSI-accredited Standards Developing Organization (SDO) operating in the healthcare arena. NOTE: Level 7 refers to the highest level of the International Standards Organization's (ISO) communications model for Open Systems Interconnection (OSI), the application level. The application level addresses definition of the data to be exchanged, the timing of the interchange, and the communication of certain errors to the application. Level 7 supports such functions as security checks, participant identification, availability checks, exchange mechanism negotiations, and, most importantly, data exchange structuring.
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| harmonized standard |
A European Norm (EN) that has been accepted by all Member States and has been published in the Official Journal of the European Communities (OJEC).
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| handwritten signature |
The scripted name or legal mark of an individual handwritten by that individual and executed or adopted with the present intention to authenticate a writing in a permanent form. NOTE: The act of signing with a writing or marking instrument such as a pen or stylus is preserved. [21CFR 11]
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