Glossaries
Glossaries
| Term | Definition |
|---|---|
| statistical analysis plan |
A document that contains a more technical and detailed elaboration of the principal features of the analysis described in the protocol, and includes detailed procedures for executing the statistical analysis of the primary and secondary variables and other data. [ICH E9]
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| Standards Development Organization (SDO) |
A domestic or international organization that plans, develops, establishes, or coordinates standards by using procedures that incorporate the attributes of openness, balance of interests, due process, an appeals process, and consensus. [After Office of Management and Budget (OMB) Circular A-119]. See also standard, data standards, CDISC standards, and Study Data Standardization Plan.
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| standard treatment |
A treatment currently in wide use and approved by FDA or other health authority, considered to be effective in the treatment of a specific disease or condition.
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| standard operating procedures (SOPs) |
Detailed, written instructions to achieve uniformity of the performance of a specific function. [ICH]
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| standard of care |
A guideline for medical management and treatment.
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| standard deviation |
Indicator of the relative variability of a variable around its mean; the square root of the variance.
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| standard |
A repeatable written norm, pattern, or model that is generally accepted by agreement, established or approved by an authority, or widely accepted and used by custom. [After https://dictionary.cambridge.org/us/dictionary/english/standard, https://www.fda.gov/media/124694/download]. See also data standards, CDISC standards, Study Data Standardization Plan, and Standards Development Organization.
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technical standard |
| sponsor-investigator |
An individual who both initiates and conducts, alone or with others, a clinical trial and under whose immediate direction the investigational product is administered to, dispensed to, or used by a subject. NOTE: The term does not include any person other than an individual (i.e., it does not include a corporation or an agency). The obligations of a sponsor-investigator include both those of a sponsor and those of an investigator. [21 CFR 50.3f] [ICH E6] See also coordinating investigator, investigator, investigator/institution, principal investigator, site investigator, sponsor-investigator, sub-investigator.
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| sponsor |
An individual, company, institution, or organization that takes responsibility for the initiation, management, and/or financing of a clinical study. [After ICH E6, WHO, 21 CFR 50.3 (e), and after IDMP] See also secondary sponsor.
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| specified substance |
Substance defined by groups of elements that describes multi-substance materials or specifies further information on substances relevant to the description of Medicinal Products. NOTE: This could include grade, units of measure, physical form, constituents, manufacturer, critical manufacturing processes (e.g. extraction, synthetic or recombinant processes), specification and the analytical methods used to determine whether a substance is in compliance with a specification. [After ISO 11615:2017, 3.1.77]
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| special purpose domain |
In the context of the Study Data Tabulation Model (SDTM), a higher level categorization of the subject-level non-observational domains, which are not classified under the SDTM general observation classes. Examples include trial design domains, relationship domains, etc. [Based on SDTM and SDTM Implementation Guide, www.CDISC.org] See also domain, general observational class.
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| special populations |
Subsets of study populations of particular interest included in clinical trials to ensure that their specific characteristics are considered in interpretation of data (e.g., geriatric). [FDA]
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| source documents |
Original documents, data, and records (e.g., hospital records, clinical and office charts, laboratory notes, memoranda, subjects' diaries or evaluation checklists, pharmacy dispensing records, recorded data from automated instruments, copies or transcriptions certified after verification as being accurate copies, microfiches, photographic negatives, microfilm or magnetic media, x-rays, subject files, and records kept at the pharmacy, at the laboratories, and at medicotechnical departments involved in the clinical trial). See also eSource document, source, original data, certified copy. [ICH; CSUICI]
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| source document verification (SDV) |
The process by which the information reported by an investigator is compared with the source records or original records to ensure that it is complete, accurate, and valid. [Schuyl and Engel, 1999; Khosla et al., Indian J. Pharm 32:180-186, 2000] See also data validation.
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| source data verification |
The process of ensuring that data that have been derived from source data accurately represent the source data.
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