Glossaries
Glossaries
| Term | Definition |
|---|---|
| data model |
Unambiguous, formally stated, expression of items, the relationship among items, and the structure of the data in a certain problem area or context of use. A data model uses symbolic conventions agreed to represent content so that content does not lose its intended meaning when communicated.
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| data management conventions |
Procedures and policies for data management (e.g., documented procedure(s) for resolving self-evident changes). [ICH E6] See self-evident change.
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| data management |
Tasks associated with the entry, transfer, and/or preparation of source data and derived items for entry into a clinical trial database. NOTE: Data management could include database creation, data entry, review, coding, data editing, data QC, locking, or archiving; it typically does not include source data capture.
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| data listing |
Set of observations organized by domain.
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| data item |
A named component of a data element. Usually the smallest component [ANSI]. See also data model, data element.
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| data interchange |
Transfer of information between two or more parties, which maintains the integrity of the contents of the data for the purpose intended. See also interoperability.
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| data integrity verification |
Process of manually supervised verification of data for internal consistency.
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| data integrity |
A condition of data reflecting the degree to which the data are complete, consistent, accurate, trustworthy, and reliable at any given time as well as consistently so maintained throughout the data life cycle. NOTE: The data should be collected and maintained in a secure manner, so that they are Attributable, Legible, Contemporaneously recorded, Original (or a true copy) and Accurate (ALCOA). Assuring data integrity requires appropriate quality and risk management systems, including adherence to sound scientific principles and good documentation practices. (After MHRA Guidance on "GxP data integrity") See also ALCOA, ALCOA+, traceability (data). Compare to data quality.
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| data entry |
Human input of data into a structured, computerized format using an interface such as a keyboard, pen-based tablet, or voice recognition. Contrast with data acquisition, electronic data capture, direct entry. See also data collection, data capture.
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| data encryption standard (DES) |
A FIPS approved cryptographic algorithm for encrypting (enciphering) and decrypting (deciphering) binary coded information. Encrypting data converts it to an unintelligible form called cipher. Decrypting cipher converts the data back to its original form called plaintext. NOTE: Data that are considered sensitive by the responsible authority or data that represent a high value should be cryptographically protected if vulnerable to unauthorized disclosure or undetected modification during transmission or while in storage. [After Federal Information Processing Standards (FIPS) Publication 46-2]
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| data element identifier |
An identifier that may include information such as the origin of the data element, the date and time of entry, or the identification number of the study subject to whom the data element applies. NOTE: Data element identifiers should be attached to each data element as it is entered or transmitted by the originator into the eCRF. [After body and glossary of FDA Final Guidance eSource]
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| data element |
Smallest unit of information in a transaction. [From body and glossary of FDA Final Guidance on eSource] See also eXtensible markup language (XML) data element, common data element, clinical study data element.
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| data collection instruments |
Documents or tools which are used to collect, record or transcribe information on substantially identical items from a group of respondents. NOTE: Instruments can be either electronic or paper based tests, questionnaires, inventories, interview schedules or guides, rating scales, and survey plans or any other forms. [After 45 CFR 63.32]
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| data collection |
In the context of clinical research, accessing and recording information that provides source data for analysis and interpretation See data entry and data capture. [CDISC]
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| data clarification form |
A form used to query an investigator and collect feedback to resolve questions regarding data.
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