Glossaries
Glossaries
| Term | Definition |
|---|---|
| study design |
Plan for the precise procedure to be followed in a clinical trial, including planned and actual timing of events, choice of control group, method of allocating treatments, blinding methods; assigns a subject to pass through one or more epochs in the course of a trial. specific design elements (e.g., crossover, parallel, dose-escalation) [Modified from Pocock, Clinical Trials: a Practical approach] See Trial Design Model. See also, arm, epoch, and visit.
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| study description |
Representation of key elements of study (e.g., control, blinding, gender, dose, indication, configuration).
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| Study Data Standardization Plan (SDSP) |
A document that describes the data standardization strategy for clinical and nonclinical studies within a development program. NOTE: A Study Data Standardization Plan is intended to include historical, current, and planned information about the use of study data standards for studies to conform with the current technical formats, and terminologies described in the FDA Data Standards Catalog which applies to CDER, CBER, and CDRH. [After http://www.phusewiki.org/wiki/images/e/ea/SDSP_Template.pdf, https://www.fda.gov/industry/fda-resources-data-standards/study-data-standards-resources, https://www.fda.gov/media/102719/download] See also standards, data standards, CDISC standards, and Standards Development Organization.
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| study completion date |
The date on which the final data for a clinical study were collected because the last study participant made the final visit to the study location (that is, last subject, last visit, or as otherwise defined in the study protocol). NOTE: See also study completion date data element on ClinicalTrials.gov.
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| study completion |
As defined in the protocol, the point at which all protocol-required activities have been executed. NOTE: According to EU CTR, this should be a clear and unambiguous definition of the end of the clinical trial in question and, if it is not the date of the last visit of the last subject, a specification of the estimated end date and a justification thereof should be included. [REGULATION (EU) No 536/2014 Article 2.26]
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| structured product label (SPL) |
The structured product labeling (SPL) specification is an HL7 ANSI-approved document markup standard that specifies the structure and semantics for the exchange of product information. [HL7]
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| structured health record information |
Structured health record information is organized into discrete fields, and may be enumerated, numeric, or codified. Examples of structured health information include: patient address (non-codified, but discrete field); diastolic blood pressure (numeric); coded result observation; coded diagnosis; patient risk assessment questionnaire with multiple-choice answers. Context may determine whether or not data are unstructured, e.g., a progress note might be standardized and structured in some eHR-s (e.g., subjective/objective/ assessment/Plan) but unstructured in others. [HL7 eHR-s FM Glossary of Terms, 2010].
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| structured data |
Data that have been organized into discrete fields, and may be enumerated, numeric, or codified.
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| stratification |
Grouping defined by important prognostic factors measured at baseline. [ICH E9]
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| stopping rules |
A statistical criterion that, when met by the accumulating data, indicates that the trial can or should be stopped early to avoid putting participants at risk unnecessarily or because the intervention effect is so great that further data collection is unnecessary.
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| stochastic |
Involving a random variable; involving chance or probability.
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| stem |
The prompt, question, or instruction in a PRO item. See also response option, item.
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| statistical significance |
The likelihood that an event occurs by chance (e.g., hypothesis is rejected). Whether or not a given result is significant depends on the significance level adopted. NOTE: For example, one may say "significant at the 5% level", which is usually represented as "p <= 0.05". This implies that when the null hypothesis is true there is only a 1 in 20 chance of rejecting it.
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| statistical method |
The particular mathematical tests and techniques that are to be used to evaluate the clinical data in a trial. [After FDA Guidance for Industry, E9 Statistical Principles for Clinical Trials, SEPTEMBER 1998]
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| statistical distribution |
A group of ordered values; the frequencies or relative frequencies of all possible values of a characteristic. [AMA Manual of Style]
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