Page 13 - Terminology-Clinical-Research

Concentration unit: The unit of measurement used for the intervention (or exposure) and the outcome of interest.
concentration of the active substance. For example, if people in the experimental group of a
controlled trial are younger than those in the control group,
Concept: Discrete notion having a single meaning. In a it will be difficult to decide whether a lower risk of death
controlled vocabulary a concept is mapped to one or more in one group is due to the intervention or the difference in
of the words that convey its meaning. ages. Age is then said to be a confounder, or a confounding
variable. Randomization is used to minimize imbalances in
Condition: The disease, disorder, syndrome, illness, confounding variables between experimental and control
or injury that is being studied. On ClinicalTrials.gov, groups. Confounding is a major concern in non-randomized
conditions may also include other health-related issues, studies.
such as lifespan, quality of life, and health risks.
Consent form: Document used during the informed
Conducting the trial: The trial design is not complete consent process that is the basis for explaining to potential
when the trial population, treatment and endpoints subjects the risks and potential benefits of a study and
have been identified and defined. In phase III and some the rights and responsibilities of the parties involved.
phase II trials in cancer, the patient population may be Note: The informed consent document provides a
randomized (randomly allocated to receive one or other
of the alternative treatments being studied) and stratified summary of a clinical trial (including its purpose, the
treatment procedures and schedule, potential risks and
(partitioned by a factor other than the treatment, often benefits, alternatives to participation, etc.) and explains an
to ensure that equal numbers of participants with a individual’s rights as a subject. It is designed to begin the
characteristic thought to affect prognosis or response to the informed consent process, which consists of conversations
intervention will be allocated to each comparison group).
The gold standard in clinical research is a scientifically between the subject and the research team. If the individual
then decides to enter the trial, s/he gives her/his official
rigorous, randomized, well controlled trial.
consent by signing the document. Synonym: informed
Confidence interval (CI): A measure of the precision of an consent form.
estimated value. The interval represents the range of values, Consumer Safety Officer (CSO): FDA official who
consistent with the data that is believed to encompass the
“true” value with high probability (usually 95%). The coordinates the review process of various applications.
confidence interval is expressed in the same units as the Content validity: The extent to which a variable (for
estimate. Wider intervals indicate lower precision; narrow example, a rating scale) measures what it is supposed to
intervals, greater precision. measure. Evidence from qualitative research demonstrating
that the instrument measures the concept of interest,
Confidence limits: The upper and lower boundaries of a
confidence interval. including evidence that the items and domains of an
instrument are appropriate and comprehensive, relative to
Confidentiality (regarding trial participants): Refers its intended measurement concept, population, and use.
to maintaining the confidentiality of trial participants Note: Testing other measurement properties will not replace
including their personal identity and all personal medical or rectify problems with content validity.
information. The trial participants’ consent to the use of
records for data verification purposes must be obtained Contingent subject trial: Planned response to an
anticipated but conditional event in a clinical trial.
prior to the trial. The Informed Consent Document will
explain how personal health information and study data Continuous data: Data with a potentially infinite number
will be used in accordance with pertinent data protection of possible values within a given range. Height, weight, and
laws and regulations. blood pressure are examples of continuous variables.

Confirmatory trial: Phase 3 trial during which the Contract Research Organization (CRO): A person or an
previously revealed actions of a therapeutic intervention are organization (commercial, academic, or other) contracted
confirmed. Note: Procedures in confirmatory trials should by the sponsor to perform one or more of a sponsor’s trial-
be set firmly in advance. related duties and functions.

Conformity assessment: The process by which compliance Contract: A written, dated, and signed agreement between
with the EMA’s Essential Requirements is assessed. two or more involved parties that sets out any arrangements
on delegation and distribution of tasks and obligations and,
Confounder: A factor that is associated with either an

TERMINOLOGY CLINICAL RESEARCH 13