Page 53 - Terminology-Clinical-Research

and other errors documented in psychological research effects of a drug. Usually all clinical trials of drugs in
comparing contemporaneous self-reported assessments and development will collect information on adverse events.
those that rely on recall from memory.
Safety: Relative freedom from harm. In clinical trials,
Risk: In clinical trials, the probability of harm or this refers to an absence of harmful side effects resulting
discomfort for subjects. Note: Acceptable risk differs from use of the product and may be assessed by laboratory
depending on the condition for which a product is being testing of biological samples, special tests and procedures,
tested. A product for sore throat, for example, will be psychiatric evaluation, and/or physical examination of
expected to have a low incidence of troubling side effects. subjects.
However, the possibility of unpleasant side effects may be
an acceptable risk when testing a promising treatment for a Salary award programs: All CIHR-funded New
life-threatening illness. Investigators, Investigators, Mid-Career Investigators,
Senior Investigators, Research Chairs not including Canada
Risk-benefit ratio: The risk a treatment places on Research Chairs, Clinician Scientist (Phase 2) and Senior
individual participants versus the potential benefits of the Research Fellowships (Phase 2), including partnered
treatment. The risk/benefit ratio may differ depending on salary opportunities, unless otherwise stated in the specific
the condition being treated. opportunity description.

Role: 1. The function or responsibility assumed by a Sample size: 1. A subset of a larger population, selected
person in the context of a clinical study. Examples include for investigation to draw conclusions or make estimates
data manager, investigator. 2. Classifier for variables that about the larger population. 2. The number of subjects in
describe “observations” in the SDTM. Role is a metadata a clinical trial. 3. Number of subjects required for primary
attribute that determines the type of information conveyed analysis.
by an observation describing variable and standardizes
rules for using the describing variable. Sample size adjustment: An interim check conducted on
blinded data to validate the sample size calculations or re-
Routes of administration: A route of administration in evaluate the sample size.
pharmacology and toxicology is the path by which a drug,
fluid, poison, or other substance is brought into contact Schedule of activities: A standardized representation of
with the body. planned clinical trial activities including interventions
(e.g., administering drug, surgery) and study administrative
RSS: Really Simple Syndication. RSS is a family of web activities (e.g., obtaining informed consent, distributing
feed formats used to publish frequently updated works such clinical trial material and diaries, randomization) as well as
as blog entries, news headlines, audio, and video – In a assessments.
standardised format.
Schedule of assessments: A tabular representation of
planned protocol events and activities, in sequence.
Synonym: flow chart.
S Scope of the trial: A definition of the general outline of

what the clinical trial will investigate.

Screen failure: Potential subject who did not meet one or
SAE: Serious Adverse Event. more criteria required for participation in a trial.

Safety and tolerability: The safety of a medical product Screen/screening (of substances): Screening is the process
concerns the medical risk to the subject, usually assessed by which substances are evaluated in a battery of tests or
in a clinical trial by laboratory tests (including clinical assays (screens) designed to detect a specific biological
chemistry and hematology), vital signs, clinical adverse property or activity. It can be conducted on a random basis
events (diseases, signs, and symptoms), and other special in which substances are tested without any preselection
safety tests (e.g., ECGs, ophthalmology). The tolerability criteria or on a targeted basis in which information on a
of the medical product represents the degree to which overt substance with known activity and structure is used as a
adverse effects can be tolerated by the subject. basis for selecting other similar substances on which to run
the battery of tests.
Safety trial: A trial that gathers information on the adverse

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