Page 9 - Terminology-Clinical-Research

and standardized data element definitions that can be CFR: Code of Federal Regulations.
used within applications and across studies to improve
biomedical research and its link with healthcare. In the first Chi-squared test: A statistical test based on comparison
iteration, CDISC SHARE will contain the existing CDISC of a test statistic to a chi - squared distribution. Used in
standards, such as CDASH and SDTM, providing machine- RevMan analyses to test the statistical significance of the
readable elements (variables) within those standards. This heterogeneity statistic.
will allow a range of applications used within organizations
to automatically access those definitions. CIHR: Canadian Institutes of Health Research.
CITI: Collaborative IRB Training Initiative.
CDISC Standard (The): CDISC term for a proposed
uniform CDISC standard intended to address the full life- Citizen: Encompasses interested representatives of the
cycle of a clinical trial including protocol representation, general public, consumers of health services, patients,
capture of source data, submission, and archiving using a caregivers, advocates and representatives from affected
set of fully integrated and consistent models, terms, and community and voluntary health organizations.
controlled vocabularies derived from the current set of
CDISC standards. Citizen engagement: The meaningful involvement of
citizens in its activities, from agenda-setting and planning
CE mark: European conformity Marking: A mandatory to decision making, implementation and review.
European marking for products falling under one of the
New Approach Directives (including medical devices, Class: A definition of objects with properties (attributes,
but excluding cosmetics, chemicals, pharmaceuticals, methods, relationships) that all objects in the class have in
foodstuffs) to indicate conformity with the health and common. [HL7, 2001] In data modeling, a class defines a
safety requirements set out in European Directive. set of objects that share the same attributes, relationships,
and semantics. A class is usually an entity that represents a
Censored: A term used in studies whose outcome is the person, place, or thing.
time to a particular event, to describe data from patients
where the outcome is unknown. A patient might be known Classification code (MedDRA): An eight digit unique
not to have had the event only up to a particular point in numeric code assigned to a MedDRA term. The code is
time, so “survival time” is censored at this point. non-expressive and is intended to fulfil a data field in
various electronic submission types.
Certain agreements: As required by Section 801 of
the Food and Drug Administration Amendments Act, Clean database: A set of reviewed data in which errors
in general, a description of any agreement between the have been resolved to meet QA requirements for error rate
Sponsor of a clinical study and the Principal Investigator and in which measurements and other values are provided
(PI) that does not allow the PI to discuss the results of the in acceptable units; database that is ready to be locked.
study or publish the study results in a scientific or academic
journal after the trial is completed. (This does not apply if Clean file: When all data cleaning is completed and
the PI is an employee of the Sponsor). database is ready for quality review and unblinding.
Certified copy: A copy of original information that has Client: A program that makes a service request of another
been verified as indicated by a dated signature, as an exact program, usually running on a server that fulfills the
copy having all of the same attributes and information request. Web browsers (such as Firefox and Microsoft
as the original. Note: The copy may be verified by dated Explorer) are clients that request HTML files from web
signature or by a validated electronic process. A certified servers.
copy of a source document may serve as a source for a
clinical investigation. Clinical benefit: A therapeutic intervention may be said to
confer clinical benefit if it prolongs life, improves function,
Certified IRB Professional: Certification awarded to and/or improves the way a subject feels.
persons who satisfy the educational and employment
requirements and pass an examination conducted by the Clinical clarification: A query resolution received from the
Applied Research Ethics National Association (ARENA), sponsor staff (medical monitors, DSMB monitoring board,
the membership division of Public Responsibility in etc.).
Medicine and Research (PRIM&R). Clinical data: Data pertaining to the medical well-being or

TERMINOLOGY CLINICAL RESEARCH 9