Glossaries
Glossaries
| Term | Definition |
|---|---|
| visit |
A protocol-defined clinical encounter that encompasses planned and contingent study interventions, procedures, and assessments that may be performed on a subject. [SDTM]
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Study Visit |
| virulence |
The ability of an infectious agent to cause severe disease, measured as the proportion of persons with the disease who become severely ill or die. [Principles of Epidemiology in Public Health Practice, Third Edition. An Introduction to Applied Epidemiology and Biostatistics, Glossary, CDC 2014] See also morbidity, vaccine.
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| virtual |
Connected but not physically co-located. NOTE: Refers to visits or encounters between investigators and subjects where information exchange is mediated through telemedicine, video conference rather than by physical presence of individuals at a shared location. Trials with one or more virtual visits are virtual trials. Where all data capture and trial procedures are conducted virtually, a trial or other investigation may be called fully virtual. [After FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency Guidance for Industry, Investigators, and Institutional Review Boards March 2020 Updated on July 2, 2020] See also remote clinical trial, decentralized clinical trial.
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| verification of data |
The checking of data for correctness or compliance with applicable standards, rules, and conventions. [FDA Glossary of Computerized system and software Development Terminology] See also source document verification (SDV).
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| verification |
The act of reviewing, inspecting, testing, checking, auditing, or otherwise establishing and documenting whether items, processes, services, or documents conform to specified requirements. Compare to validation where suitability to purpose is also established.
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| variance |
A measure of the variability in a sample or population. It is calculated as the mean squared deviation (MSD) of the individual values from their common mean. In calculating the MSD, the divisor n is commonly used for a population variance and the divisor n-1 for a sample variance.
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| variable |
Any attribute, phenomenon, characteristic, or event that can have different qualitative or quantitative values. [After Statistical Language - What are Variables?, Australian Bureau of Statistics, October 2013] See also dependent variable, derived variable, global assessment variable, primary outcome variable, qualitative variable, quantitative variable, secondary outcome variable, study variable, supporting variables, surrogate variable.
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| validation |
Process of establishing suitability to purpose. NOTE: Validation is accomplished by planning how to measure and/or evaluate suitability to purpose; then executing the plan and documenting the results. [ICH E6] See also software validation, data validation, psychometric validation, criterion validation (COA), content validation (COA), construct validation (COA).
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validity |
| valid |
Well grounded on principles of evidence. [After FDA Glossary of Computerized System and Software Development Terminology]
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Sound |
| vaccine efficacy |
The proportional comparison of infection rate or other disease endpoints between vaccinated and unvaccinated groups measured in randomized controlled trials. NOTE: The method for calculating vaccine efficacy can be found here: https://www.cdc.gov/csels/dsepd/ss1978/lesson3/section6.html. Efficacy is a measurement made during a clinical trial, effectiveness is how well the vaccine works out in the real world. [After Greenwood et al., Proc R Soc Med. 1915; 8 (Sect Epidemiol State Med): 113-194, The Statistics of Anti-typhoid and Anti-cholera Inoculations, and the Interpretation of such Statistics in general. After Piero Ollario, The Lancet Infectious Diseases, Feb 17th, 2021] See also vaccine effectiveness, effectiveness, efficacy, randomized controlled trial (RCT).
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| vaccine effectiveness |
Vaccine protection measured in observational studies that include people with underlying medical conditions who have been administered vaccines by different health care providers under real-world conditions. [How Flu Vaccine Effectiveness and Efficacy are Measured, Questions & Answers, CDC January 29, 2016] See also vaccine efficacy, efficacy, effectiveness, randomized controlled trial (RCT).
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| vaccine |
A medicinal product inducing immunity against disease, most often to prevent occurrence of a disease, (e.g., a preventative vaccine against infectious disease), but also to treat a disease, (e.g., a therapeutic vaccine against cancer). NOTE: The vaccines against infectious disease may contain various ingredients of diverse origin (such as inactivated or attenuated organisms, particular antigens related to the infectious agent, live recombinant vector against antigens in vivo and adjuvants) [After NCI Dictionary of Cancer Terms. After European Pharmacopoeia section 5.1.] See also treatment, prevention, prophylaxis, biological product, virulence.
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| user site testing (UST) |
Any testing that takes place outside of the developer's controlled environment. NOTE: Terms such as beta test, site validation, user acceptance test, installation verification, and installation testing have all been used to describe user site testing. User site testing encompasses all of these and any other testing that takes place outside of the developer's controlled environment. [from General Principles of software Validation; Final Guidance, section 5.2.6]
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| use error (device) |
User action or lack of action that was different from that expected by the manufacturer and caused a result that (1) was different from the result expected by the user and (2) was not caused solely by device failure and (3) did or could result in harm. [FDA, Applying Human Factors and Usability Engineering to Medical Devices]
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| use case |
An explicit scenario designed to help in determining whether a system/process is capable of performing the functions required for a particular use. a use case might describe, for example, how a study coordinator would use a tablet computer to capture medical history data.
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