Page 4 - Terminology-Clinical-Research

Administrative coordinator - program leader: The Adverse event (AE): Any untoward medical occurrence
individual who assumes the role of administrative in a patient or clinical investigation subject administered
coordinator for the grant must also be in a role of program a pharmaceutical product and which does not necessarily
leader. The administrative coordinator assumes all have a causal relationship with this treatment. An
responsibility for administrative matters related to the grant adverse event (AE) can therefore be any unintended sign
including but not limited to submitting the application (including an abnormal laboratory finding), symptom, or
and coordinating any required reporting. In cases when disease temporally associated with the use of a medicinal
there are multiple program leaders, the administrative (investigational) product, whether or not related to the
coordinator must be from a Canadian academic or research medicinal (investigational) product.
environment at a CIHR eligible institution. Note: CIHR
requires all program leaders to be fully accountable Adverse experience: See adverse event.
for setting and overseeing the intellectual and strategic
direction of the CIHR-funded program of research. The Adverse reaction: See adverse drug reaction.
dual role as administrative coordinator does not imply AE: Adverse Event.
a superior contribution to the leadership of the research
program. Aggregate data: See Summary-level data.

Admission criteria: Basis for selecting target population Alert: To cause a high-priority signal (or warning) to
for a clinical trial. Subjects must be screened to ensure that be transmitted to the relevant stakeholder by way of the
their characteristics match a list of admission criteria and local system or another system (usually according to an
that none of their characteristics match any single one of established set of rules). Note: For example, the system
the exclusion criteria set up for the study. may transmit an alert to a patient’s cardiologist that the
patient has experienced another heart attack. Another
Adolescents: Subjects are aged 12 to less than 18 years. example is that the pharmacy system may transmit an alert
to the prescribing physician that a potentially dangerous
Adults: Subjects are aged 18 to 64 years.
drug-drug interaction may occur based on the current list of
Advanced Therapy IMP (ATIMP): Advance Therapy medications. Another example is that the system may notify
Investigational Medicinal Products are medicinal products a patient’s physician that laboratory results (that are not
involving cell or gene therapy or tissue engineering. within normal limits) are available.

Adverse drug experience: See adverse drug reaction. Algorithm: Step-by-step procedure for solving a
mathematical problem; also used to describe step-by
Adverse drug reaction (ADR): Any noxious and step procedures for making a series of choices among
unintended response associated with the use of a drug in alternative decisions to reach a calculated result or decision.
humans. 1. Post-approval: an adverse event that occurs at
doses normally used in man for prophylaxis, diagnosis, or Aliquot: A part that is a definite fraction of a whole, as in
therapy of diseases or for modification of physiological aliquot samples for laboratory testing or analysis.
function. 2. Pre-approval: an adverse event that occurs
at any dose and where a causal relationship is at least Allocation: A clinical trial design strategy used to assign
a reasonable possibility. Note: FDA 21 CFR 310.305 participants to an arm of a study. Types of Allocations
include randomized and nonrandomized.
defines an adverse drug experience to include any adverse
event, “whether or not considered to be drug-related.” Alpha error: The likelihood that a relationship observed
CDISC (Clinical Data Interchange Standards Consortium) between two variables is due to chance. The probability of
recognizes that current usage incorporates the concept of a Type 1 error.
causality.
Amendment: A written description of a change(s) to, or
Adverse effects: An adverse event for which the causal formal clarification of, a protocol.
relation between the drug/intervention and the event is at
least a reasonable possibility. The term ‘adverse effect’ American National Standards Institute (ANSI):
applies to all interventions, while ‘adverse drug reaction’ Founded in 1918, ANSI itself does not develop standards.
(ADR) is used only with drugs. In the case of drugs an ANSI’s roles include serving as the coordinator for US
adverse effect tends to be seen from the point of view of the voluntary standards efforts, acting as the approval body
drug and an adverse reaction is seen from the point of view to recognize documents developed by other national
of the patient.

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