Glossaries
Glossaries
| Term | Definition |
|---|---|
| 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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| clinical document |
A documentation of clinical observations and services. NOTE: an electronic document should incorporate the following characteristics: persistence, stewardship, potential for authentication, wholeness, and human readability. [SPL]
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| clinical development plan |
A document that describes the collection of clinical studies that are to be performed in sequence, or in parallel, with a particular active substance, device, procedure, or treatment strategy, typically with the intention of submitting them as part of an application for a marketing authorization. NOTE: The plan should have appropriate decision points and allow modification as knowledge accumulates. [from ICH E9] See also development plan.
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| clinical data |
Data pertaining to the medical well-being or status of a patient. Category also includes clinical reports and individual patient data (IPD) as defined in the EMA Policy 0070 Implementation Guide. [http://www.ema.eoropa.eu/docs/en_GB/document_library/REPORT/2014/10/WC500174378.PDF]
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| clinical clarification |
A query resolution received from the sponsor staff (medical monitors, DSMB monitoring board, etc.). See also self-evident change.
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| clinical benefit |
A therapeutic intervention may be said to confer clinical benefit if it prolongs life, improves function, and/or improves the way a subject feels.
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| client |
A program that makes a service request of another program, usually running on a server, that fulfills the request. Web browsers (such as Firefox and Microsoft explorer) are clients that request HTML files from web servers.
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| clean file |
When all data cleaning is completed and database is ready for quality review and unblinding.
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| clean database |
A set of reviewed data in which errors have been resolved to meet QA requirements for error rate and in which measurements and other values are provided in acceptable units; database that is ready to be locked. See also database lock, clean file.
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| class |
A definition of objects with properties (attributes, methods, relationships) that all objects in the class have in common. [HL7, 2001] in data modeling, a class defines a set of objects that share the same attributes, relationships, and semantics. A class is usually an entity that represents a person, place, or thing.
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| CHI (consolidated health informatics) |
CHI began as an eGov initiative to establish a portfolio of existing health information interoperability standards (health vocabulary and messaging) enabling all agencies in the federal health enterprise to "speak the same language" based on common enterprise-wide business and information technology architectures. CHI is currently managed under the Office of the National Coordinator for Health Informational Technology's (ONC) Federal Health Architecture (FHA) Program Management Office. Ref: The United States Health Information Knowledgebase [USHIK]. [HITSP]
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| challenge agent |
A non-investigational medicinal product (NIMP) given to trial subjects to produce a physiological response that is necessary before the pharmacological action of the investigational medicinal product can be assessed. [After Recommendations from the expert group on clinical trials for the implementation of Regulation (EU) No 536/2014' dd 28 June 2017]
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