Glossaries
Glossaries
| Term | Definition |
|---|---|
| stratification |
Grouping defined by important prognostic factors measured at baseline. [ICH E9]
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| stopping rules |
A statistical criterion that, when met by the accumulating data, indicates that the trial can or should be stopped early to avoid putting participants at risk unnecessarily or because the intervention effect is so great that further data collection is unnecessary.
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| stochastic |
Involving a random variable; involving chance or probability.
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| stem |
The prompt, question, or instruction in a PRO item. See also response option, item.
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| statistical significance |
The likelihood that an event occurs by chance (e.g., hypothesis is rejected). Whether or not a given result is significant depends on the significance level adopted. NOTE: For example, one may say "significant at the 5% level", which is usually represented as "p <= 0.05". This implies that when the null hypothesis is true there is only a 1 in 20 chance of rejecting it.
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| statistical method |
The particular mathematical tests and techniques that are to be used to evaluate the clinical data in a trial. [After FDA Guidance for Industry, E9 Statistical Principles for Clinical Trials, SEPTEMBER 1998]
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| statistical distribution |
A group of ordered values; the frequencies or relative frequencies of all possible values of a characteristic. [AMA Manual of Style]
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| statistical analysis plan |
A document that contains a more technical and detailed elaboration of the principal features of the analysis described in the protocol, and includes detailed procedures for executing the statistical analysis of the primary and secondary variables and other data. [ICH E9]
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| Standards Development Organization (SDO) |
A domestic or international organization that plans, develops, establishes, or coordinates standards by using procedures that incorporate the attributes of openness, balance of interests, due process, an appeals process, and consensus. [After Office of Management and Budget (OMB) Circular A-119]. See also standard, data standards, CDISC standards, and Study Data Standardization Plan.
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| standard treatment |
A treatment currently in wide use and approved by FDA or other health authority, considered to be effective in the treatment of a specific disease or condition.
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| standard operating procedures (SOPs) |
Detailed, written instructions to achieve uniformity of the performance of a specific function. [ICH]
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| standard of care |
A guideline for medical management and treatment.
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| standard deviation |
Indicator of the relative variability of a variable around its mean; the square root of the variance.
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| standard |
A repeatable written norm, pattern, or model that is generally accepted by agreement, established or approved by an authority, or widely accepted and used by custom. [After https://dictionary.cambridge.org/us/dictionary/english/standard, https://www.fda.gov/media/124694/download]. See also data standards, CDISC standards, Study Data Standardization Plan, and Standards Development Organization.
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technical standard |
| sponsor-investigator |
An individual who both initiates and conducts, alone or with others, a clinical trial and under whose immediate direction the investigational product is administered to, dispensed to, or used by a subject. NOTE: The term does not include any person other than an individual (i.e., it does not include a corporation or an agency). The obligations of a sponsor-investigator include both those of a sponsor and those of an investigator. [21 CFR 50.3f] [ICH E6] See also coordinating investigator, investigator, investigator/institution, principal investigator, site investigator, sponsor-investigator, sub-investigator.
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