Glossaries
Glossaries
| Term | Definition |
|---|---|
| clinical study data element |
A single observation associated with a subject in a clinical study. A data element in an eCRF represents the smallest unit of observation captured for a subject in a clinical investigation. NOTE: Examples include birth date, white blood cell count, pain severity measure, and other clinical observations made and documented during a study. Data element identifiers should be attached to each data element as it is entered or transmitted by the originator into the eCRF. See also eCRF, data element identifier, data originator, item. [After FDA Guidance for Industry Electronic Source Data in Clinical Investigations , Body text and Glossary]
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| clinical study |
A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge. There are two main types of clinical studies: clinical trials (also called interventional studies) and observational studies. [ClinicalTrials.gov] See also clinical trial.
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| clinical significance |
Change in a subject's clinical condition regarded as important whether or not due to the test intervention. NOTE: some statistically significant changes (in blood tests, for example) have no clinical significance. The criterion or criteria for clinical significance should be stated in the protocol. The term "clinical significance" is not advisable unless operationally defined.
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| clinical research subject |
A person who is enrolled into a clinical study or trial. See also study, trial, and study population.
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| clinical research coordinator (CRC) |
Study site staff member who executes, manages, and coordinates research protocols in the clinic setting including screening, enrollment, monitoring of patient candidates/participants, and administration of informed consent. Other duties may be included depending on the study site.
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clinical coordinator; research coordinator; study coordinator; trial coordinator |
| clinical research associate (CRA) |
Person employed by a sponsor or by a contract research organization acting on a sponsor's behalf, who monitors the progress of investigator sites participating in a clinical study. At some sites (primarily in academic settings), clinical research coordinators are called CRAs.
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| clinical research and development |
The testing of a drug compound in humans primarily done to determine its safety and pharmacological effectiveness. Clinical development is done in phases, which progress from very tightly controlled dosing of a small number of subjects to less tightly controlled studies involving large numbers of patients. [SQA]
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| clinical pharmacology |
Science that deals with the characteristics, effects, properties, reactions, and uses of drugs, particularly their therapeutic value in humans, including their toxicology, safety, pharmacodynamics, and pharmacokinetics (ADME).
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| clinical outcome assessment (COA) qualification |
A formal conclusion by FDA that, within the stated context of use, the results of the COA measurement can be relied upon to have a specific interpretation and application. NOTE: For qualified COAs, FDA permits drug developers to use the COA in the qualified context in IND and NDA/BLA submissions without requesting that the relevant CDER review group reconsider and reconfirm the suitability of the COA. [FDA Clinical Outcome Assessment (COA) Glossary]
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| clinical outcome assessment (COA) |
Any assessment that may be influenced by human choices, judgment, or motivation and may support or refute treatment benefit. NOTE: Unlike biomarkers that rely completely on an automated process or algorithm, COAs reflect interpretation of reporting from a patient, a clinician, or an observer. There are four types of COAs. See also patient-reported outcome (PRO), clinician-reported outcome (ClinRO), observer-reported outcome (ObsRO), and performance outcome (PerfO). [FDA Clinical Outcome Assessment (COA) Glossary]
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| clinical investigation |
Any experiment that involves a test article and one or more human subjects, and that either must meet the requirements for prior submission to the FDA or the results of which are intended to be later submitted to, or held for inspection by, the FDA as part of an application for a research or marketing permit. Considered synonymous with clinical research by FDA. See clinical study, clinical trial. [FDA Science & Research]
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| clinical hold (of a clinical trial) |
An order issued by FDA to the sponsor to delay a proposed clinical investigation or to suspend an ongoing investigation. NOTE: The clinical hold order may apply to one or more of the investigations covered by an IND. [21 CFR 312.42] See also suspension (of a clinical trial), termination (of a clinical trial), temporary halt (of a clinical trial).
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| clinical encounter |
Contact between subject/patient and healthcare practitioner/researcher, during which an assessment or activity is performed. Contact may be physical or virtual. [CDISC]
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| clinical efficacy |
Power or capacity to produce a desired effect (i.e., appropriate pharmacological activity in a specified indication) in humans. [SQA]
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| clinical document architecture |
Specification for the structure and semantics of "clinical documents" for the purpose of exchange. [HL7; SPL]
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