Glossaries
Glossaries
| Term | Definition |
|---|---|
| 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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| certified IRB professional (CIP) |
Persons certified to participate on an institutional review board, who satisfy the educational and employment requirements and pass an examination conducted by the applied Research ethics national association (aRena), the membership division of Public Responsibility in Medicine and Research (PRiM&R).
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| certified copy |
A copy (irrespective of the type of media used) of the original record that has been verified (i.e., by a dated signature or by generation through a validated process) to have the same information, including data that describe the context, content, and structure, as the original. [ICH E6 (R2)]
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| cell therapy |
The prevention or treatment of human disease by the administration of cells that have been selected, multiplied, and pharmacologically treated or altered outside the body (ex vivo), or methods (pharmacological as well as nonpharmacological) to modify the function of intrinsic cells of the body for therapeutic purposes (in vivo). NOTE: Cell therapies can be classified based on therapeutic indication, cell type, source of cells, and underlying technology, among others, in medical and regulatory contexts. [After https://www.sciencedirect.com/topics/neuroscience/cell-therapy; After Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007.] See also regenerative medicine therapy, regenerative medicine advanced therapy, gene therapy, biological product.
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| CDISC standards |
A set of models, implementation guides, controlled vocabularies, and exchange formats developed by the Clinical Data Interchange Standards Consortium (CDISC), which are intended to provide for consistent use of common representations of data, terms and specifications. NOTE: These standards apply to translational research, electronic submission of clinical data, and the life-cycle of clinical product development, which includes protocol representation, data collection, aggregation, tabulation, and analysis and unambiguous information exchange across disparate systems. [After https://www.ncbi.nlm.nih.gov]. See also standard, data standards, Study Data Standardization Plan, and Standards Development Organization.
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