Glossaries
Glossaries
| Term | Definition |
|---|---|
| schedule of activities |
A standardized representation of planned clinical trial activities including interventions (e.g., administering drug, surgery) and study administrative activities (e.g., obtaining informed consent, distributing clinical trial material and diaries, randomization) as well as assessments. See also schedule of assessments. Compare to study design schematic.
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Schedule of Events; SoA |
| sample size calculation |
A statistical calculation to determine the number of subjects required for the primary analysis, which should be large enough to provide a reliable answer to the questions addressed and should be determined by the primary objective of the trial. [After ICH E9, 3.5]
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| sample size adjustment |
An interim check conducted on blinded data to validate the sample size calculations or reevaluate the sample size. [After ICH E9]
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| sample size |
A subset of a larger population, selected for investigation to draw statistically valid conclusions or make estimates about the larger population. NOTE: This number is presented in the protocol and statistical analysis plan. [After ICH E9]
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| safety and tolerability |
The safety of a medical product concerns the medical risk to the subject, usually assessed in a clinical trial by laboratory tests (including clinical chemistry and hematology), vital signs, clinical adverse events (diseases, signs, and symptoms), and other special safety tests (e.g., ECGs, ophthalmology). The tolerability of the medical product represents the degree to which overt adverse effects can be tolerated by the subject. [ICH E9]
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| safety |
Relative freedom from harm. In clinical trials, this refers to an absence of harmful side effects resulting from use of the product and may be assessed by laboratory testing of biological samples, special tests and procedures, psychiatric evaluation, and/or physical examination of subjects.
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| SAFE |
BioPharma(TM) Digital Identity and Signature Standard.
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| route of administration (ROA) |
Path by which the pharmaceutical product is taken into or makes contact with the body. [After ISO 11615:2017, 3.1.76] See also administration (substance), administrable dosage form.
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| role (CDISC classifier) |
Classifier for variables that describe "observations" in the SDTM. Role is a metadata attribute that determines the type of information conveyed by an observation-describing variable and standardizes rules for using the describing variable. [SDTM]
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| risk based monitoring |
A systematic, prioritized, risk-based approach to monitoring clinical trials. [After ICH E6(R2), 5.18.3]
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| risk |
In clinical trials, the probability of harm or discomfort for subjects. NOTE: Acceptable risk differs depending on the condition for which a product is being tested. A product for sore throat, for example, will be expected to have a low incidence of troubling side effects. However, the possibility of unpleasant side effects may be an acceptable risk when testing a promising treatment for a life-threatening illness.
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| RHIO (Regional Health Information Organization) |
A group of organizations with a business stake in improving the quality, safety and efficiency of healthcare delivery. RHIOs are the building blocks of the proposed National Health Information Network (NHIN) initiative.
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| retrospective study |
A study with planned observations collected predominantly before study start (i.e. backward-looking). Note: Examples are case-control studies or retrospective cohort studies when the observations from the selected subjects occurred before study start. [after ClinicalTrials.gov] See also prospective study, observational study, adaptive design, clinical study.
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| retrospective data capture |
Capture of clinical trial data is retrospective when it is recalled from memory rather than captured contemporaneously in real-time. NOTE: Retrospective capture is important in PROs because of "recall bias" and other errors documented in psychological research comparing contemporaneous self-reported assessments and those that rely on recall from memory.
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| results posting date (results submission date) |
The date and time the summary information about the results of the clinical study are submitted to a structured, publicly accessible, Web-based results database, such as the ClinicalTrials.gov results database. [ClinicalTrials.gov]
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