Glossaries
Glossaries
| Term | Definition |
|---|---|
| severe |
An adjective for grading intensity on a relative scale describing a symptom, outcome or event. Note: The term 'severe' is often used to describe the intensity (severity) of a specific event (as in mild, moderate, or severe myocardial infarction); the event itself, however, may be of relatively minor medical significance (such as severe headache). This is not the same as 'serious,' which is based on patient/event outcome or action criteria usually associated with events that pose a threat to a patient's life or functioning. Seriousness (not severity) serves as a guide for defining regulatory reporting obligations. [After ICH E2A, B] See also serious adverse event and serious adverse drug reaction.
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| server |
A computer that controls a central repository of data, files, and/ or applications that can be accessed and/or manipulated in some manner by client computers. NOTE: A file server hosts files for use by client machines. A web server supports browser-based use of central applications.
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| serious risk |
Risk of a serious adverse drug experience. [505-1(b) of FD&C Act (21 USC. 355-1(b)]
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| serious breach |
A breach of Clinical Trial Regulation (EU) No 536/2014 or of the version of the protocol applicable at the time of the breach, which is likely to affect to a significant degree the safety and rights of a subject or the reliability and robustness of the data generated in the clinical trial. [Article 52 of Regulation (EU) 536/2014 and Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol] See also privacy breach.
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| serious adverse experience (SAE) |
Any experience that suggests a significant hazard, contra-indication, side effect or precaution. See also serious adverse event.
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| serious adverse event (SAE) |
Adverse event that: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/ incapacity, or is a congenital anomaly/ birth defect. NOTE: For further information, see the ICH Guideline for Clinical safety Data Management: Definitions and standards for expedited Reporting. [After ICH E2A, B] Compare to serious adverse drug reaction.
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| serious adverse drug reaction |
Adverse drug reaction that at any dose of the drug: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/ incapacity, or is a congenital anomaly/ birth defect. NOTE: FDA 21 CFR 310.305 defines an adverse drug experience to include any adverse event, "whether or not considered to be drug-related." CDISC recognizes that current usage incorporates the concept of causality. [1. WHO Technical Report 498(1972); 2. After ICH E2A, B] See ICH E6 definition and serious and severe definitions.
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| sensitive data |
Any data that, in the event of re-identification, would harm a patient in terms of employability, reputation, insurability, or self-esteem or results in loss of income. NOTE: Examples include history of alcoholism, drug abuse, risky behavior, or venereal disease. [HIPAA]
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| SEND (standard for the exchange of nonclinical data) |
The CDISC standard for the exchange of nonclinical data whose focus is on data collected from animal toxicology studies. [CDISC]
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| semantic interoperability |
The ability of data shared by systems to be understood at the level of fully defined domain concepts. [ISO 18308]
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| semantic |
In the context of a technical specification, semantic refers to the meaning of an element as distinct from its syntax. syntax can change without affecting semantics. [HL7]
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| self-evident change |
A data discrepancy that can be easily and obviously resolved on the basis of existing information on the CRF (e.g., obvious spelling errors or the patient is known to be a male and a date of last pregnancy is provided). See also discrepancy.
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| secondary sponsor |
Additional individuals, organizations or other legal persons, if any, that have agreed with the primary sponsor to take on responsibilities of sponsorship. [WHO, CTR item 6]
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| secondary outcome variable |
Data on secondary outcomes are used to evaluate additional effects of the intervention. The primary outcome is the outcome of greatest importance. [after CONSORT statement] See also outcome, endpoint.
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| secondary objective |
Secondary objectives are supportive or ancillary questions of interest in a trial that will provide further information on the use of the treatment. See also primary objective, objective.
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