Page 12 - Terminology-Clinical-Research

individuals followed-up or traced over time in a cohort conducted primarily through primary care physicians rather
study. than researchers at academic facilities.

Cohort study: Study of a group of individuals, some Comorbidity: The presence of one or more diseases
of whom are exposed to a variable of interest, in which or conditions other than those of primary interest. In a
subjects are followed over time. Cohort studies can be study looking at treatment for one disease or condition,
prospective or retrospective. some individuals may have other diseases or conditions
that could affect their outcomes (comorbidity may be a
COI: Conflict of Interest. confounder).

Collaboration (funding): A business transaction in which Comparative study: One in which the investigative drug
two or more entities exchange things of value. This value is compared against another product, either active drug or
can be financial, in-kind, or benefits related to visibility/ placebo.
exposure, or publicity. It also involves a display of
affiliation that stops short of product endorsement. Comparator (product): An investigational or marketed
product (i.e. active control) or placebo, used as a reference
Collaborator: A Collaborator is an organization other than in a clinical trial.
the Sponsor that provides support for a clinical study. This
support may include funding, design, implementation, data Compassionate use: A method of providing experimental
analysis, or reporting. Note: CIHR defines a Collaborator therapeutics prior to final regulatory agency approval
as an individual whose role in the proposed activities is for use in humans. This procedure is used with very sick
to provide a specific service (e.g., access to equipment, individuals who have no other treatment options. Often,
provision of specific reagents, training in a specialized case-by-case approval must be obtained by the patient’s
technique, statistical analysis, access to a patient physician from the regulatory agency for “compassionate
population, etc.). use” of an experimental drug or therapy.

Combination ATIMP: An ATIMP (Advanced Therapy Competent Authority (CA): A regulatory agency in an
Investigational Medicinal Product) involving a medical EU Member State or for medical devices, a Competent
device. Authority is the organization with the authority to act on
behalf of the government of a Member State to ensure that
Combination product: 1. A product comprising two or all medical devices meet the essential requirements laid
more individual products. 2. Two or more separate products down in the Directives prior to marketing authorisation.
packaged together in a single package or as a unit. 3. A
product that is packaged separately but is used only with Completed file: File for which all data cleaning is
another product. complete and database is ready for quality review and
unblinding.
Common data element: A structured item characterized
by a stem and response options together with a history of Completion: 1. Subject completion: the case where
usage that can be standardized for research purposes across a subject ceases active participation in a trial because
studies conducted by and for NIH. Note: The mark up or the subject has, or is presumed to have, followed all
tagging facilitates document indexing, search and retrieval, appropriate conditions of a protocol. 2. Study completion:
and provides standard conventions for insertion of codes. according to the study protocol, the point at which all
protocol-required activities have been executed.
Common Technical Document: A format agreed upon by
ICH to organize applications to regulatory authorities for Compliance (in relation to trials): Adherence to trial-
registration of pharmaceuticals for human use. related requirements, good clinical practice (GCP)
requirements, and the applicable regulatory requirements.
Community leader: An individual who has direct
involvement with an affected community, understands Comptrollership: Having clear accountabilities, effective
the needs of the community and how research can lead to control over resources, sound risk management and
useful practical outcomes for the community, and who can performance assessments, and an open reporting of results
facilitate the involvement of the community in the research in relation to the expenditure of public funds.
process.
Computer application: See Application.
Community-based clinical trial (CBCT): A clinical trial

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