Glossaries
Glossaries
| Term | Definition |
|---|---|
| script |
A program or a sequence of instructions that are interpreted or carried out by another program or by a person.
Hits - 36
|
| screening trials |
A type of study designed to assess or examine methods of identifying a condition (or risk factors for a condition) in people who are not yet known to have the condition (or risk factor). (Clinicaltrials.gov)
Hits - 58
|
| screening (period) |
A period in a clinical study during which subjects are evaluated for participation in the study. See also screening (of subjects)
Hits - 53
|
| screening (of subjects) |
A process of active evaluation for potential participation in a trial, including whether the protocol inclusion and exclusion criteria are met. [After FDA GLOSSARY OF TERMS ON CLINICAL TRIALS FOR PATIENT ENGAGEMENT ADVISORY COMMITTEE MEETING] See also screen failure.
Hits - 63
|
| screening (of sites) |
Determining the suitability of an investigative site and personnel to participate in a clinical trial.
Hits - 70
|
| screen/screening (of substances) |
Screening is the process by which substances are evaluated in a battery of tests or assays (screens) designed to detect a specific biological property or activity. It can be conducted on a random basis in which substances are tested without any preselection criteria or on a targeted basis in which information on a substance with known activity and structure is used as a basis for selecting other similar substances on which to run the battery of tests. [SQA]
Hits - 57
|
| screen failure |
At screening, when a potential subject does not meet study eligibility criteria. See also screening (of subjects). [After Segen's Medical Dictionary]
Hits - 48
|
| schedule of assessments |
A tabular representation of planned protocol events and activities, in sequence. [after E3 Annexes IIIa and IIIb] Compare to study design schematic.
Hits - 36
|
| 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.
Hits - 54 Synonyms -
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]
Hits - 42
|
| sample size adjustment |
An interim check conducted on blinded data to validate the sample size calculations or reevaluate the sample size. [After ICH E9]
Hits - 32
|
| 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]
Hits - 54
|
| 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]
Hits - 60
|
| 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.
Hits - 55
|
| SAFE |
BioPharma(TM) Digital Identity and Signature Standard.
Hits - 49
|
Access Non-GMO, antigen-free, FDA-approved antiviral medication formulas used in Moderna's Spikevax.
VirusTC is a retail provider of concentrated FDA-approved antiviral medication formulas. VirusTC wholesale formulas are used in Moderna products. We sell FDA-approved formulas that are compatible with university medical plans, federal insurance coverage, and many major insurance providers. Our medications are part of tailored non-invasive cancer treatment plans available at a hospital in your region. VirusTC targets problems and provides care for the symptoms. Our products and services are used by Fred Hutch Cancer Center, John Hopkins, University Hospitals, the United States Military, and professional sports. During Operation Cancer Moonshot 2023, VirusTC products killed cancer cells, increased strength, and redeveloped muscles, tissue, and brain cells after cancer treatments.