Glossaries
Glossaries
Term | Definition |
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random sample |
Members of a population selected by a method designed to ensure that each person in the target group has an equal chance of selection.
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random number table |
Table of numbers with no apparent pattern used in the selection of random samples for clinical trials.
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random allocation |
Assignment of subjects to treatment (or control) groups in an unpredictable way. NOTE: in a blinded study, assignment sequences are concealed, but available for disclosure in the event a subject has an adverse experience.
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radiopharmaceutical medicinal product |
Any medicinal product which, when ready for use, contains one or more radionuclides (radioactive isotopes) included for a medicinal purpose. [DIRECTIVE 2001/83/EC Article 1.(11)]
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race |
An arbitrary classification of a taxonomic group that is a division of a species. It usually arises as a consequence of geographical isolation within a species and is characterized by shared heredity, physical attributes and behavior, and in the case of humans, by common history, nationality, or geographic distribution. (NCI)
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questionnaire |
A set of questions or items shown to a respondent in order to get answers for research purposes. [PRO Draft Guidance] See also instrument, survey.
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query resolution |
The closure of a query usually based on information contained in a data clarification.
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query management |
Ongoing process of data review, discrepancy generation, and resolving errors and inconsistencies that arise in the entry and transcription of clinical trial data.
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query |
A request for clarification on a data item collected for a clinical trial; specifically a request from a sponsor or sponsor's representative to an investigator to resolve an error or inconsistency discovered during data review.
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quantitative variable |
One that can be measured and reported numerically to reflect a quantity or amount, ideally on a continuum.
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quality of life (QoL) |
A broad ranging concept that incorporates an individual's physical health, psychological state, level of independence, social relationships, personal beliefs, and their relationships to salient features of the environment. NOTE: Quality of life is one way to measure the benefits or negative impacts of an "improvement" measured in terms of a physiological or psychological symptom. QoL research seeks to quantify what an intervention means to a patient's sense that their life has changed. NOTE: See also definition from FDA eCOA Glossary. [WHO Group, 1994]
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quality control (QC) |
The operational techniques and activities undertaken within the quality assurance system to verify that the requirements for quality of the trial related activities have been fulfilled. [ICH E6 R2 Glossary]
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quality assurance (QA) |
All those planned and systematic actions that are established to ensure that the trial is performed and the data are generated, documented (recorded), and reported in compliance with good clinical practice (GCP) and the applicable regulatory requirement(s). [ICH E6 R2 Glossary]
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qualitative variable |
One that cannot be measured on a continuum and represented in quantitative relation to a scale (race or sex, for example). Data that fit into discrete categories according to their attributes.
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public protocol title |
A brief description intended for the lay public in easily understood language. NOTE: Public title may also be referred to as "brief title." [Segen's Medical Dictionary] See also protocol title, official protocol title.
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brief protocol title; short protocol title |
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