Page 14 - Terminology-Clinical-Research

if appropriate, on financial matters. The protocol may serve Controlled vocabulary: A finite set of values that represent
as the basis of a contract. the only allowed values for a data item. These values may
be codes, text, or numeric.
Contraindication: A specific circumstance in which the
use of certain treatments are not allowed usually because Controlled: See controlled trial.
they could be harmful or fatal.
Coordinating committee: A committee that a sponsor may
Contribution (cash): Contributions in cash by a partner for organize to coordinate the conduct of a multicenter trial.
levering by CIHR.
Coordinating investigator: An investigator assigned
Contribution (in-kind): In-kind (cash equivalent) the responsibility for the coordination of investigators at
contributions provided by a partner that: 1. Are generally different centers participating in a multicenter trial.
entirely relevant and central to the research (such judgment
may be referred to peer review) for levering by CIHR. 2. Correlation: The degree to which two or more variables
Would have to be purchased by the recipient if they were are related. Typically the linear relationship is measured
not provided by a partner. with either Pearson’s correlation or Spearman’s rho. Note:
Correlation does not necessarily mean causation.
Control (of electronic records): To prepare and maintain
case histories and other records for regulated clinical Cost-effectiveness analysis: An economic analysis that
investigations. Note: Control is often used as a casual views effects in terms of overall health specific to the
synonym for the terms in 21 CFR 312.62 requiring problem, and describes the costs for some additional health
investigative sites to prepare, maintain, and retain adequate gain.
and accurate case histories.
Covariate (prognostic): Factor or condition that influences
Control group: A control is the standard by which outcome of a trial.
experimental observations are evaluated. In many clinical CQI: Continuous Quality Improvement.
trials, one group of patients will be given an experimental
drug or treatment, while the control group is given either a CRF data: Subset of clinical trial data that are entered into
standard treatment for the illness or a placebo. fields on a CRF.

Control number: A unique six-digit identification number CRF (paper): Case report form in which the data items
Health Canada assigns to each clinical trial application are linked by the physical properties of paper to particular
received. pages. Note: Data are captured manually and any
comments, notes, and signatures are also linked to those
Control(s): 1. Comparator against which the study
treatment is evaluated [e.g., concurrent (placebo, no data items by writing or typescript on the paper pages.
treatment, dose-response, active), and external (historical, Cross over: See cross-over design.
published literature)] 2. Computer: processes or operations
intended to ensure authenticity, integrity, and confidentiality Cross-over design/cross-over trial: Describes a clinical
of electronic records. Note: The protocol incorporates trial in which groups of participants receive two or more
scientific rationale for selection of comparator and interventions in a particular order. For example, a two-by-
describes how the comparator serves as a reference point two cross-over design involves two groups of participants.
for the evaluation. SDTM provides a code list for type of One group receives drug A during the initial phase of the
control. trial, followed by drug B during a later phase. The other
group receives drug B during the initial phase, followed
Controlled terminology: Synonym for controlled by drug A. So during the trial, participants “cross over”
vocabulary. to the other drug. All participants receive drug A and drug
B at some point during the trial but in a different order,
Controlled trial: A type of clinical trial in which depending on the group to which they are assigned. One
observations made during the trial are compared to type of intervention model (design).
a standard, called the control. The control may be
observations of a group of participants in the same trial or CTSU: Clinical and Translational Science Unit (formerly
observations from outside the trial (for example, from an GCRC).
earlier trial, which is called a historical control).
Cumulative environmental effects: The combined effects,

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