Page 8 - Terminology-Clinical-Research

allocation of subject subsets to particular procedures or observations and other data pertinent to the investigation
treatment groups. on each individual administered the investigational drug
(device or other therapy) or employed as a control in the
Brand name: See Proprietary name. investigation. Note: Case histories include the case report
forms and supporting data including, for example, signed
Bridging study endpoints: Bridging studies test whether
there is a difference in the pharmacokinetics of a drug with and dated consent forms and medical records including, for
example, progress notes of the physician, the individual’s
different subgroups of patients or methods of drug delivery. hospital chart(s), and the nurses’ notes. The case history for
A bridging study could, for example, be used to compare each individual shall document that informed consent was
populations who have very different Body Mass Indices obtained prior to participation in the study.
(BMIs), to determine whether the dosing should be adjusted
by weight. Case report form (CRF): 1. A printed, optical, or

electronic document designed to record all of the protocol-
Browser: Computer program that runs on the user’s required information to be reported to the sponsor for each
desktop computer and is used to navigate the World Wide trial subject. 2. A record of clinical study observations and
Web.
other information that a study protocol designates must be
completed for each subject. Note: In common usage, CRF
can refer to either a CRF page, which denotes a group of
C one or more data items linked together for collection and
display, or a casebook, which includes the entire group of
CRF pages on which a set of clinical study observations
and other information can be or have been collected, or the
information actually collected by completion of such CRF
Cache: Storage area on a computer’s hard drive where pages for a subject in a clinical study.
the browser stores (for a limited time) web pages and/or
graphic elements. Case report tabulations (CRT): In a paper submission,
listings of data that may be organized by domain (type of
Canadian Institutes of Health Research (CIHR): The data) or by subject.
Canadian Institutes of Health Research (CIHR) is Canada’s
federal funding agency for health research. Composed of 13 CAT classification: Procedural advice on the provision
Institutes, they collaborate with partners and researchers to of scientific recommendation on CAT (classification of
support the discoveries and innovations that improve health advanced therapy medicinal products).
and strengthen health care system.
Categorical data: Data evaluated by sorting values
Carry-over effect: Effects of treatment that persist after (for example, severe, moderate, and mild) into various
treatment has been stopped, sometimes beyond the time of categories.
a medication’s known biological activity.
Casual effect: An association between two characteristics
CAS number: Chemical Abstract Services (CAS) are that can be demonstrated to be due to cause and effect, such
unique numerical identifiers for chemical elements, as a change in one causes the change in the other. Causality
compounds, polymers, biological sequences, mixtures and can be demonstrated by experimental studies such as
alloys. A service of the American Chemical Society that controlled trials (e.g., that an experimental intervention
indexes and compiles abstracts of worldwide chemical causes a reduction in mortality). However, causality can
literature called Chemical Abstracts. often not be determined from an observational study.

Case control study: A scientific study that compares a Causality assessment: An evaluation performed by a
group of people with a disease (such as leukemia) to a medical professional concerning the likelihood that a
similar group of people without that disease. This type therapy or product under study caused or contributed to an
of study compares the levels of exposure (for example, adverse event.
radiation or chemical) each group had before appearance of
the disease. CCTO: Cancer Clinical Trials Office.

Case history: An adequate and accurate record prepared CDISC SHARE: A global, accessible, electronic library,
and maintained by an investigator that records all which, through advanced technology, enables precise

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