Glossaries
Glossaries
| Term | Definition |
|---|---|
| data clarification |
Answer supplied by the investigator in response to a query. NOTE: The investigator may supply a new data point value to replace the initial value or a confirmation of the queried data point.
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| data capture |
The process of collecting and recording measures and assessments for a specific purpose. NOTE: Data are said to be captured when they are extracted as permanent records for use in a new context or created as a source document in that context. An example would be data that are manually copied or otherwise extracted from an EHR that are then transferred into a clinical trial database to be used for a clinical trial. [After Working with Data, Australian National Data Service, Accessed 4 Sept 2020; AFter FDA Guidance on Use of Electronic Health Record Data in Clinical Investigations Guidance for Industry, July 2018] See also data entry, EDC (electronic data capture).
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| data acquisition |
Capture of data into a structured, computerized format without a human-to-computer interface (i.e., from another measuring instrument or computerized source). Contrast with data entry, electronic data capture.
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| data |
Representations of facts, concepts, or instructions in a manner suitable for communication, interpretation, or processing by humans or by automated means. [FDA]
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