term
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stringclasses 5
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|---|---|---|---|---|---|---|---|
umbrella trial
|
<b>CDISC Definition:</b> A type of trial conducted under a master protocol and designed to test multiple investigational drugs administered as single drugs or as drug combinations in a single disease population. [After US FDA, Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics Guidance for Industry, 2022]. See also master protocol, adaptive design, umbrella trial design.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
unblinding
|
<b>CDISC Definition:</b> Identification of the treatment assignment to the subject, investigators, and/or other trial personnel. [After EUPATI Toolbox: Within-trial decisions: Unblinding and termination. 2023]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
unexpected adverse drug reaction
|
<b>CDISC Definition:</b> An adverse drug reaction, whose nature, severity, specificity, or outcome is not consistent with the term or description used in the applicable product information (e.g., IB for an unapproved investigational product or PI/summary of product characteristics for an approved product, and/or scientific literature). [After ICH E6 (R2)]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
unexpected serious risk
|
<b>CDISC Definition:</b> A serious adverse drug experience that is not listed in the labeling of a drug, or that may be symptomatically or pathophysiologically related to an adverse drug experience identified in the labeling, but differs because of greater severity, specificity, or prevalence. [505-1(b) of FD&C Act (21 USC. 355-1(b)]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
uniform resource locator (URL)
|
<b>CDISC Definition:</b> Address of a web page, for example, appliedclinicaltrialsonline.com.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
use case
|
<b>CDISC Definition:</b> 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.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
use error (device)
|
<b>CDISC Definition:</b> 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]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
user site testing (UST)
|
<b>CDISC Definition:</b> 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]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
vaccine effectiveness
|
<b>CDISC Definition:</b> 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).
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
vaccine efficacy
|
<b>CDISC Definition:</b> 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).
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
vaccine
|
<b>CDISC Definition:</b> 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.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
valid
|
<b>CDISC Definition:</b> Well grounded on principles of evidence. [After FDA Glossary of Computerized System and Software Development Terminology]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
validation
|
<b>CDISC Definition:</b> 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).
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
variable
|
<b>CDISC Definition:</b> 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.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
variance
|
<b>CDISC Definition:</b> 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.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
verification of data
|
<b>CDISC Definition:</b> 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).
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
verification
|
<b>CDISC Definition:</b> 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.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
virtual
|
<b>CDISC Definition:</b> 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.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
virulence
|
<b>CDISC Definition:</b> 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.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
visit
|
<b>CDISC Definition:</b> A protocol-defined clinical encounter that encompasses planned and contingent study interventions, procedures, and assessments that may be performed on a subject. [SDTM]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
vocabulary
|
<b>CDISC Definition:</b> 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]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
vulnerable subjects
|
<b>CDISC Definition:</b> 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.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
Warning Letter
|
<b>CDISC Definition:</b> 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]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
washout period
|
<b>CDISC Definition:</b> The interval of time that a participant enrolled in a study must not receive a specified treatment(s) before starting a study intervention(s). NOTE: A washout may be required before joining a study or before changing treatments within a study. [After https://metastatictrialtalk.org/inside-clinical-trials/washout-period/]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
web browser
|
<b>CDISC Definition:</b> A computer program that interprets HTML and other Internet languages and protocols and displays web pages on a computer monitor.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
web page
|
<b>CDISC Definition:</b> A single page on a website, such as a home page.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
web scraping
|
<b>CDISC Definition:</b> The automated process of programmatically and systematically collecting information on the web and processing it into more easily analyzable formats that can be serialized. [After NNLM, "Web Scraping", 05/25/22, https://www.nnlm.gov/guides/data-glossary/web-scraping] See also AI prompt, Generative AI (GenAI).
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
web server
|
<b>CDISC Definition:</b> A computer server that delivers HTML pages or files over the World Wide Web. See also server.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
website
|
<b>CDISC Definition:</b> 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.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
weighting
|
<b>CDISC Definition:</b> An adjustment in a value based on scientific observations within the data.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
well-being (of the trial subjects)
|
<b>CDISC Definition:</b> The physical and mental integrity of the subjects participating in a clinical trial. [ICH]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
withdrawal
|
<b>CDISC Definition:</b> 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.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
within-subject differences
|
<b>CDISC Definition:</b> In a crossover trial, variability in each subject is used to assess treatment differences.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
World Wide Web
|
<b>CDISC Definition:</b> All the resources and users on the Internet that are using HTTP protocols. Also called the web and www.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
XML (eXtensible Markup Language)
|
<b>CDISC Definition:</b> 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.
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
zoonosis
|
<b>CDISC Definition:</b> 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]
|
[
"CDISC Glossary.xlsx"
] | null |
excel
|
CDISC Glossary.xlsx
|
Glossary Terminology 2025-09-26
| null |
The Multi
|
Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard
|
[
"https://mrctcenter.org/glossaryterm/clinical-research/"
] | null |
web
|
https://mrctcenter.org/glossaryterm/clinical-research/
| null | null |
Post-Trial Responsibilities
|
Continued Access
|
[
"https://mrctcenter.org/glossaryterm/clinical-research/"
] | null |
web
|
https://mrctcenter.org/glossaryterm/clinical-research/
| null | null |
Proactive Safety Surveillance
|
A Global Approach
|
[
"https://mrctcenter.org/glossaryterm/clinical-research/"
] | null |
web
|
https://mrctcenter.org/glossaryterm/clinical-research/
| null | null |
Project
|
Specific Websites
|
[
"https://mrctcenter.org/glossaryterm/clinical-research/"
] | null |
web
|
https://mrctcenter.org/glossaryterm/clinical-research/
| null | null |
Health and Human Services
|
What is Medical Research?
|
[
"https://mrctcenter.org/glossaryterm/clinical-research/"
] | null |
web
|
https://mrctcenter.org/glossaryterm/clinical-research/
| null | null |
FDA
|
The Drug Development Process Step 3: Clinical Research
|
[
"https://mrctcenter.org/glossaryterm/clinical-research/"
] | null |
web
|
https://mrctcenter.org/glossaryterm/clinical-research/
| null | null |
The Future is Connected
|
Standards and AI Powering Digital Transformation
|
[
"https://www.cdisc.org/"
] | null |
web
|
https://www.cdisc.org/
| null | null |
Access CDISC end-to
|
end Foundational and Therapeutic Area standards
|
[
"https://www.cdisc.org/"
] | null |
web
|
https://www.cdisc.org/
| null | null |
Therapeutic areas
|
latest updates
|
[
"https://www.ema.europa.eu/"
] | null |
web
|
https://www.ema.europa.eu/
| null | null |
Post
|
authorisation
|
[
"https://www.ema.europa.eu/"
] | null |
web
|
https://www.ema.europa.eu/
| null | null |
Podcast
|
Inside EMA
|
[
"https://www.ema.europa.eu/"
] | null |
web
|
https://www.ema.europa.eu/
| null | null |
HealthNotHype
|
EMA's first social media campaign with creators
|
[
"https://www.ema.europa.eu/"
] | null |
web
|
https://www.ema.europa.eu/
| null | null |
First-in
|
class treatment to delay onset of type 1 diabetes
|
[
"https://www.ema.europa.eu/"
] | null |
web
|
https://www.ema.europa.eu/
| null | null |
Wiskott
|
Aldrich syndrome
|
[
"https://www.ema.europa.eu/"
] | null |
web
|
https://www.ema.europa.eu/
| null | null |
Enpr
|
EMA) November 2025
|
[
"https://www.ema.europa.eu/"
] | null |
web
|
https://www.ema.europa.eu/
| null | null |
Start date
|
20 November 2025, 13:00 (CET)
|
[
"https://www.ema.europa.eu/"
] | null |
web
|
https://www.ema.europa.eu/
| null | null |
End date
|
21 November 2025, 12:50 (CET)
|
[
"https://www.ema.europa.eu/"
] | null |
web
|
https://www.ema.europa.eu/
| null | null |
EMA multi
|
stakeholder workshop on artificial intelligence (AI)
|
[
"https://www.ema.europa.eu/"
] | null |
web
|
https://www.ema.europa.eu/
| null | null |
European Medicines Agency
|
Medtech Europe bilateral meeting
|
[
"https://www.ema.europa.eu/"
] | null |
web
|
https://www.ema.europa.eu/
| null | null |
A Custom Webtools Rating widget
|
Hidden by field_ema_hide_rating for this node.
|
[
"https://www.ema.europa.eu/"
] | null |
web
|
https://www.ema.europa.eu/
| null | null |
South
|
East Asia
|
[
"https://www.who.int/"
] | null |
web
|
https://www.who.int/
| null | null |
COVID
|
19 dashboard
|
[
"https://www.who.int/"
] | null |
web
|
https://www.who.int/
| null | null |
Lifetime toll
|
840 million women faced partner or sexual violence
|
[
"https://www.who.int/"
] | null |
web
|
https://www.who.int/
| null | null |
Read WHO Director
|
General's speeches
|
[
"https://www.who.int/"
] | null |
web
|
https://www.who.int/
| null | null |
November 2025 12
|
00 – 13:00 CET
|
[
"https://www.who.int/"
] | null |
web
|
https://www.who.int/
| null | null |
WHO EPI-WIN Webinar
|
attributes of pathogen genomic data platforms supporting timely and equitable sharing
|
[
"https://www.who.int/"
] | null |
web
|
https://www.who.int/
| null | null |
November 2025 13
|
30 – 15:00 CET
|
[
"https://www.who.int/"
] | null |
web
|
https://www.who.int/
| null | null |
From Data to Impact
|
Advancing Healthcare Associated Infection Surveillance for Safer Care and a Healthier Future
|
[
"https://www.who.int/"
] | null |
web
|
https://www.who.int/
| null | null |
Beyond HLM4
|
Implementing the 2025 Political Declaration on NCDs and Mental Health
|
[
"https://www.who.int/"
] | null |
web
|
https://www.who.int/
| null | null |
November 2025 18
|
30 – 20:00 CET
|
[
"https://www.who.int/"
] | null |
web
|
https://www.who.int/
| null | null |
Study record managers
|
refer to the
|
[
"https://clinicaltrials.gov/"
] | null |
web
|
https://clinicaltrials.gov/
| null | null |
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