Glossaries

An infectious disease that is transmissible from animals to humans. [Principles of Epidemiology in Public Health Practice, Third Edition. An Introduction to Applied Epidemiology and Biostatistics, Glossary, CDC 2014]

A set of rules for encoding documents and data in a format that is both human readable and machine readable. [After Study Data Technical Conformance Guide, Technical Specifications Document, March 2019; After W3C Extensible Markup Language (XML)] See also eXtensible markup language (XML) data element, Define-XML.

All the resources and users on the Internet that are using HTTP protocols. Also called the web and www.

In a crossover trial, variability in each subject is used to assess treatment differences.

The subject-initiated act of discontinuing participation in a clinical study. NOTE: Withdrawal can range from the subject's complete withdrawal from study procedures and follow-up activities, to the subject's withdrawal from study-related interventions. [After Guidance on Withdrawal of Subjects from Research: Data Retention and Other Related Issues, September 21, 2010] See also discontinuation.

The physical and mental integrity of the subjects participating in a clinical trial. [ICH]

An adjustment in a value based on scientific observations within the data.

A collection of web pages and other files. A site can consist of a single web page, thousands of pages, or custom created pages that draw on a database associated with the site.

A computer server that delivers HTML pages or files over the World Wide Web. See also server.

A single page on a website, such as a home page.

A computer program that interprets HTML and other Internet languages and protocols and displays web pages on a computer monitor.

A period in a clinical study during which subjects receive no treatment for the indication under study and the effects of a previous treatment are eliminated (or assumed to be eliminated).

A written communication from FDA notifying an individual or firm that the agency considers one or more products, practices, processes, or other activities to be in violation of the Federal FD&C Act, or other acts, and that failure of the responsible party to take appropriate and prompt action to correct and prevent any future repeat of the violation may result in administrative and/or regulatory enforcement action without further notice. [FDA]

Individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate. NOTE: Examples are members of a group with a hierarchical structure, such as medical, pharmacy, dental, and nursing students, subordinate hospital and laboratory personnel, employees of the pharmaceutical industry, members of the armed forces, and persons kept in detention. Other vulnerable subjects include patients with incurable diseases, persons in nursing homes, unemployed or impoverished persons, patients in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and those incapable of giving consent. [After ICH E6 R2 Glossary] See also human subject, patient, human subject, data subject, clinical research subject, participant, study participant.

The collection of terms, which refer to concepts, that are used by, understood by, or available for use by an individual or group within a language system. [After NCI Thesaurus]