Glossaries
Glossaries
| Term | Definition |
|---|---|
| temporary halt (of a clinical trial) |
An interruption not provided in the protocol of the conduct of a clinical trial by the sponsor with the intention of the sponsor to resume it. [After EU CTR] See also termination (of a clinical trial), clinical hold (of a clinical trial), suspension (of a clinical trial).
Hits - 6
|
| technology provider |
A person, company, or other entity who develops, produces, and sells software applications and/or hardware for use in conducting clinical trials and/or in analyzing clinical trial data and or submitting clinical trial information for regulatory approval.
Hits - 8 Synonyms -
technology vendor |
| target population |
Population of patients to which the indication of a medicinal product applies. NOTE: The term applies to investigational and authorized medicinal products. [After ISO 11615.2012]
Hits - 8
|
| target enrollment |
The number of subjects in a cohort and in the entire study intended to be enrolled to reach the planned sample size. NOTE: Target enrollments are set by sample size calculations so that statistical and scientific objectives of a trial will have a likelihood of being met as determined by algorithm or other specified process. [After ICH E9; After clinicaltrials.gov] See also sample size.
Hits - 10
|
| tabulation dataset |
A dataset structured in a tabular format. NOTE: The CDISC Study Data Tabulation Model (SDTM) defines standards for tabulation datasets that fulfill FDA requirements for submitting clinical trial data.
Hits - 11
|
| table of roles and responsibilities |
A cumulative record documenting operational access and authorizations of study personnel to electronic systems used in eClinical trials.
Hits - 7
|
| t-test |
A statistical test used to compare the means of two groups of test data.
Hits - 7
|
| system |
People, machines, software, applications, and/or methods organized to accomplish a set of specific functions or objectives. [ANSI]
Hits - 14
|
| synthetic data |
Data that are artificially created rather than being generated by actual events. NOTE: Data are often created with the help of algorithms and used for a wide range of activities, including as test data for new products and tools, for model validation, and in AI optimization. [After The Ultimate Guide to Synthetic Data in 2020, August 29, 2020]. See also artificial intelligence.
Hits - 15
|
| syntactic |
The order, format, content of clinical trial data and/or documents as distinct from their meaning. NOTE: Syntactic interoperability is achieved when information is correctly exchanged between two systems according to structured rules whether or not sensible meaning is preserved. See also semantic, semantic interoperability.
Hits - 13
|
| synopsis |
Brief overview prepared at the conclusion of a study as a routine part of a regulatory submission, summarizing the study plan and results; includes numerical summary of efficacy and safety results, study objective, criteria for inclusion, methodology, etc. [after ICH E3]
Hits - 8
|
| symptom |
An experience reported by a patient that may indicate a disease. NOTE: Some examples of symptoms are pain, fatigue, nausea, and anxiety. [After NCI Glossary] See also diagnosis, sign.
Hits - 12
|
| suspension (of a clinical trial) |
An interruption of the conduct of a clinical trial by a Member State of the EU. NOTE: Similar to FDA "clinical hold". [After EU CTR] See also clinical hold (of a clinical trial), termination (of a clinical trial), temporary halt (of a clinical trial).
Hits - 9
|
| survey |
Any means (e.g., questionnaire, diary, interview script, group of items) that is used to collect PRO data. NOTE: survey refers to the content of the group of items and does not necessarily include the training and scoring documents generally not seen by respondents. [from ISOQOL comments on PRO Guidance] Compare to instrument.
Hits - 12
|
| surrogate variable |
A variable that provides an indirect measurement of effect in situations where direct measurement of clinical effect is not feasible or practical. [ICH E9]
Hits - 15
|
Access Non-GMO, antigen-free, generic antiviral medication formulas used in Moderna's Spikevax.
VirusTC is a retail provider of concentrated generic antiviral medication formulas. VirusTC wholesale formulas are used in Moderna products. We sell FDA approved formulas that are compatible with university medical plans, federal insurance coverage, and many major insurance providers. Our medications are part of tailored non-invasive cancer treatment plans available at a hospital in your region. VirusTC targets problems and provides care for the symptoms. Our products and services are used by Fred Hutch Cancer Center, Mayo Clinic, John Hopkins, University Hospitals, the United States Military, and professional sports. During Operation Cancer Moonshot 2023, VirusTC products killed cancer cells, increased strength, and redeveloped muscles, tissue, and brain cells after cancer treatments.