Glossary- Clinical Trials Terminology – A – C

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Glossary- Clinical Trials Terminology – A – C

A

Adverse Drug Reaction (ADR) In the preapproval clinical experience with a new medicinal product or its new usages, particularly as the therapeutic dose(s) may not be established: all noxious and unintended responses to a medicinal product related to any dose should be considered adverse drug reactions. The phrase “responses to a
medicinal product” means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility, i.e., the relationship cannot be ruled out. Regarding marketedmedicinal products: a response to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of diseases or for modification of physiological function

Adverse Event (AE) Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding),
symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product

Audit (of a clinical trial) A systematic and independent examination of trial-related activities and documents to determine whether the evaluated trial-related activities were conducted, and the data were recorded, analyzed, and accurately reported according to the protocol, sponsor’s standard operating procedures (SOPs), good clinical practice (GCP), and the applicable regulatory requirement(s).

Audit Trail Documentation that allows reconstruction of the course of events.


B

Baseline Assessment Assessment of subjects as they enter a trial and before they receive any treatment.

Bioavailability Rate and extent to which a drug is absorbed or is otherwise available to the treatment site in the body

Bioequivalence Scientific basis on which generic and brand-name drugs are compared. To be considered bioequivalent, the bioavailability of two products must not differ significantly when the two products are given in studies at the same dosage under similar conditions.

Blind Study One in which the subject or the investigator (or both) are unaware of what trial product a subject is taking

Blinding/masking A procedure in which one or more parties to the trial are kept unaware of the treatment assignment(s). Single-blinding usually refers to the subject(s) being unaware, and double-blinding usually refers to the subject(s), investigator(s), monitor, and, in some cases, data analyst(s) being unaware of the treatment assignment(s).


C

Carry-Over Effect Effects of treatment that persist after treatment has been stopped, sometimes beyond the time of a medication’s known biological activity.

Case Report Form (CRF) A printed, optical, or electronic document designed to record all of the protocol required information to be reported to the sponsor on each trial subject.

Causality Assessment Determining whether there is a reasonable possibility that the drug caused or contributed to an adverse event. It includes assessing temporal relationships, dechallenge/rechallenge information, association (or lack of association) with underlying disease, and the presence (or absence) of a more likely cause

Clinical Research Associate (CRA) Person employed by a sponsor, or by a contract research organization acting on a sponsor’s behalf, who monitors the progress of investigator sites participating in a clinical study.

Clinical Research Coordinator (CRC) Person who handles most of the administrative responsibilities of a clinical trial, acts as liaison between investigative site and sponsor, and reviews all data and records before
a monitor’s visit.

Clinical Significance Change in a subject’s clinical condition regarded as important whether or not due to the test article. Some statistically significant changes (in blood tests, for example) have no clinical significance. The criterion or criteria for clinical significance should be stated in the protocol


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