Glossaries
Glossaries
| Term | Definition |
|---|---|
| design configuration |
Clinical trial design developed to compare treatment groups in a clinical trial. NOTE: The configuration usually requires randomization to one or more treatment arms, each arm being allocated a different (or no) treatment. examples include: Parallel Group Design, Crossover Design, Factorial Designs. [After ICH E9]
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| derived variable |
New variable created as a function of existing variables and/or application of mathematical functions. See also variable, raw data.
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| deployment |
Readying an electronic clinical trial system for field use by providing or disseminating capture devices, tokens, or passwords for users of an activated system. See activation.
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| dependent variable |
A variable that is expected to change as a result of an experiment. Dependent variables are influenced by independent variables. [After AMA Manual of Style] See also independent variable.
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| demographic data |
Characteristics of subjects or study populations, which include such information as age, sex, family history of the disease or condition for which they are being treated, and other characteristics relevant to the study in which they are participating.
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| Define-XML |
A table in XML that transmits metadata that describes any tabular dataset structure. NOTE: When used with the CDISC content standards, it provides the metadata for human and animal model tabular datasets such as SDTM, SEND, and ADaM. [After CDISC.org] See also eXtensible markup language (XML) data element, XML (eXtensible Markup Language).
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| deep learning |
A subset of machine learning that is part of the broader family of machine learning methodologies based on artificial neural networks. A deep neural network has multiple layers between input and output layers to progressively extract higher level features from the raw input. [After DeepAI Machine Learning Glossary and Terms] See also machine learning, artificial intelligence (AI).
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| Declaration of Helsinki |
A set of recommendations or basic principles that guide medical doctors in the conduct of biomedical research involving human subjects. it was originally adopted by the 18th World Medical assembly (Helsinki, Finland, 1964) and recently revised (64th WMA General Assembly, Fortaleza, Brazil, October 2013).
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| decision rule |
Succinct statement of how a decision will be reached based upon the expected foreseen clinical benefits in terms of outcomes of the primary endpoint. [FDA documentation]
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| decentralized clinical trial (DCT) |
A trial in which data capture, administration of medication, and possibly other procedures are done at the subject's location, e.g., at home or by telemedicine, mobile technology, and local HCPs (like family physicians, general practitioners). NOTE: The procedures (entry of data, medical tests, clinical evaluations, objective measures, observations) for capturing safety and efficacy measurements and observations may be done in-person by a traveling clinician or nurse so DCTs are not necessarily virtual. The responsibility for preparation, maintenance and retention of source records may be allocated to a centralized investigator or sponsor investigator. [After CTTI Recommendations: Decentralized Clinical Trials, September 2018] See also remote clinical trial, virtual, visit.
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| de-identified information |
Records that have had enough personally identifiable information removed or obscured such that the remaining information does not identify an individual, and there is no reasonable basis to believe that the information can be used to identify an individual. [Guide to Protecting Personally Identifiable Information (PII): Special Publication NIST pubs/800-122]
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| de-identification |
The process of removing potentially identifying data or data elements to render data into a form that does not identify individuals and where identification is not likely to take place. NOTE: A general term for a process of removing the association between a set of identifying data and the data subject. Examples of potentially identifying data include name, birth date, social security number, home address, telephone number, e-mail address, medical record numbers, health plan beneficiary numbers, full-face photographic images). [After ISO/TS 25237: 2008 - Health Informatics - Pseudonymization; HIPAA: 45 CFR, 164.514] See also anonymization.
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| date of first enrollment |
Date or date and time of first subject enrollment into a study, as verifiable by a convention that is consistent with authoritative regulatory criteria. [Modified from ICH E3] Compare to study start date.
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| dataset |
A collection of structured data in a single file. [CDISC] Compare to analysis dataset, tabulation dataset.
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| database lock |
Action taken to prevent further changes to a clinical trial database or any equivalent clinical data storage system. NOTE: Locking of a database is done after review, query resolution, and a determination has been made that the database is ready for analysis.
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