Glossaries
Glossaries
| Term | Definition |
|---|---|
| auxiliary medicinal product |
A medicinal product that is related to the specific needs of the clinical trial as described in the protocol, but not as an investigational medicinal product. NOTE: Auxiliary medicinal products may be authorised for marketing in a country or region or non-authorised. [after EU-CTR]
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| authorization |
The process of giving someone permission to do or have something. In multi-user computer systems, a system administrator defines for the system which users are allowed access to the system and what privileges of use are permitted. [HL7 EHR-S FM Glossary of Terms, 2010].
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| authorised investigational medicinal product |
A medicinal product that is currently authorised for marketing in a country or region and used as an investigational medicinal product, irrespective of changes to the labelling of the medicinal product. [After EU CTR (EU) No 536/2014] See also investigational medicinal product.
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| authorised auxiliary medicinal product |
A medicinal product that is currently authorised for marketing in a country or region, that is related to the specific needs of the clinical trial as described in the protocol, but not as an investigational medicinal product, regardless of labelling of the auxiliary medicinal product. [after EU CTR]
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| audit trail |
A process that captures details such as additions, deletions, or alterations of information in an electronic record without obliterating the original record. An audit trail facilitates the reconstruction of the history of such actions relating to the electronic record. [after ICH E6, CSUICI]
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| audit report |
A written evaluation by the auditor of the results of the audit. [Modified from ICH E6 Glossary]
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| audit certificate |
Document that certifies that an audit has taken place (at an investigative site, CRO, or clinical research department of a pharmaceutical company). [ICH E6 Glossary]
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| audit |
A systematic and independent examination of trial-related activities and documents to determine whether the evaluated trial-related activities were conducted and the data were recorded, analyzed, and accurately reported according to the protocol, sponsor's standard operating procedures (SOPs), good clinical practice (GCP), and the applicable regulatory requirement(s). [ICH E6 Glossary]
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| attribute (n) |
In data modeling, refers to specific items of data that can be collected for a class.
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| attributable |
A quality by which records and data can be traced back to the subject to whom they pertain, as well as to those persons who have acted on the records.
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| assessment |
The interpretation or evaluation of an obtained value by using a test, tool, instrument, or expert judgement of the status of a study subject. [After BEST Resource] See also variable, outcome, endpoint.
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| artificial intelligence (AI) |
A system's ability to correctly interpret external data, to learn from such data, and to use those learnings to achieve specific goals and tasks through flexible adaptation. [Kaplan, A; Haenlein, M (1 January 2019) Business Horizons; IEEE-USA POSITION STATEMENT. Artificial Intelligence Research, Development & Regulation Adopted by the IEEE-USA, Board of Directors (February 2017)] See also machine learning, deep learning, natural language processing, synthetic data.
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| arm (protocol) |
A planned path through the study that describes which treatments and/or controls apply to the subjects as they progress through the study. [After BRIDG] See also control, control group.
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| approval letter |
An official communication from FDA to inform an applicant of a decision to allow commercial marketing consistent with conditions of approval. [Modified from 21 CFR 314.3; Guidance to industry and FDA staff (10/08/2003)]
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| approval (in relation to Institutional Review Boards) |
The affirmative decision of the IRB that the clinical trial has been reviewed and may be conducted at the institution site within the constraints set forth by the IRB, the institution, good clinical practice (GCP), and the applicable regulatory requirements. [ICH E6]
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