Glossaries
Glossaries
| Term | Definition |
|---|---|
| database |
A collection of data or information, typically organized for ease and speed of search and retrieval.
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| data validation |
Process used to determine whether data are accurate, authentic, complete, and/or compliant with applicable standards, rules, and conventions. NOTE: The process may include format checks, completeness checks, check key tests, reasonableness checks, and limit checks. [After FDA.; ISO] See also data integrity, validation.
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| data type |
Data types define the structural format of the data carried in the attribute and influence the set of allowable values an attribute may assume. [HL7]
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| data transformations |
Algorithmic operations on data or data sets to achieve a meaningful set of derived data for analysis. [ADaM] See also derived variable.
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| data subject |
In the context of privacy guidelines, An individual who is the subject of personal data, persons to whom data refers, and from whom data are collected, processed, and stored. [after ISO/TS 2537:2008; and EU GDPR] See also study participant, participant.
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| data storage |
To maintain data by placing the data, or a copy of the data, onto an electronically accessible device for preservation (either in plain-text or encrypted format). [HL7 eHR-s FM Glossary of Terms, 2010].
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| data standards |
Defined rules, conventions, guidelines, characteristics, methods, formats, and terminologies that provide structure and consistency for exchange and utilization of data. NOTE: Data standards may describe the elements and relationships necessary to achieve the unambiguous exchange of data between disparate information systems. [After https://www.fda.gov/media/124694/download Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research Guidance for Industry MARCH2019, NCI Thesaurus]. See also interoperability, standard, CDISC standards, Study Data Standardization Plan, and Standards Development Organization.
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| data sharing |
Providing clinical trial data or access to data and final results to key stakeholders with the goal of increasing scientific knowledge and ultimately better therapies for patients. NOTE: guiding principles for data sharing: (1) maximize the benefits of clinical trials while minimizing the risks or harm of sharing clinical trial data, (2) respect individual participants whose data are shared, (3) increase public trust in clinical trials and the sharing of trial data, and (4) conduct the sharing of clinical trial data in a fair manner. [After National Academies of Sciences, Institute of Medicine. Sharing Clinical Trial Data: Maximizing Benefits, Minimizing Risk. Washington, DC: National Academies Press, 2015, accessed 2022-09-07]
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| data selection criteria |
The rules by which particular data are selected and/ or transferred between the point of care and the patient record; subsequently, from the patient record to the database; and from database to inclusion in sub-population analyses.
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| data security |
Degree to which data are protected from the risk of accidental or malicious alteration or destruction and from unauthorized access or disclosure. [FDA]
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| data quality |
A dimension of data contributing its trustworthiness and pertaining to accuracy, sensitivity, validity, and suitability to purpose. Key elements of data quality include attribution, legibility (decipherable, unambiguous), contemporaneousness, originality (i.e., not duplicated), accuracy, precision, completeness, consistency (logical, not out of range), and those who have modified the data. NOTE: Scientists may reasonably trust data that are accurate (high quality) that have also been reviewed by investigators and protected from unauthorized alteration (high integrity). See also ALCOA, data integrity.
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| data originator |
Metadata characterizing the entity creating a data element in an eCRF for a clinical investigation. NOTE: Per FDA Final Guidance on eSource, "Each data element is associated with an origination type that identifies the source of its capture in the eCRF. This could be a person, a computer system, a device, or an instrument that is authorized to enter, change, or transmit data elements into the eCRF (also sometimes known as an author)." See also data element, data element originator, origin. [CDISC, Note is from FDA Final Guidance on eSource]
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| data origin |
Source of information collected in the course of a clinical trial, specifically used to differentiate between data as collected versus data that are derived or calculated. NOTE: In CDISC, a metadata attribute defined for each dataset variable in the Define.xml document of an SDTM submission that refers to the source of a variable (e.g., CRF, derived, sponsor defined, PRO, etc.). See also data element originator.
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| data monitoring committee (DMC) |
Group of individuals with pertinent expertise that reviews on a regular basis accumulating data from an ongoing clinical trial. The DMC advises the sponsor regarding the continuing safety of current participants and those yet to be recruited, as well as the continuing validity and scientific merit of the trial. NOTE: A DMC can recommend stopping a trial if it finds toxicities or if treatment is proved beneficial. [After FDA guidance on establishment and operation of clinical trial data monitoring committees]
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Data and Safety Monitoring Board; DSMB |
| data monitoring |
Process by which clinical data are examined for completeness, consistency, and accuracy for the duration of the study lifecycle. NOTE: Monitoring is undertaken by qualified study personnel following a specific process and auditable methods. See also ALCOA+
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