Page 22 - Terminology-Clinical-Research

Enrollment (cumulative): Current enrollment as well as a treatment preference or finds out that one arm of a
any ever-enrolled subjects who have ended participation. comparative trial offers a clinically therapeutic advantage
should disclose this information to subjects participating in
Enrollment (current): Subjects actively continuing to the trial.
participate in a clinical trial as of the current date.
Equivalence trial: A trial with the primary objective of
Enrollment (target): The number of subjects in a class or showing that the response to two or more treatments differs
group (including the total for the entire trial) intended to by an amount that is clinically unimportant. Note: This is
be enrolled in a trial. Note: Target enrollments are set so usually demonstrated by showing that the true treatment
that statistical and scientific objectives of a trial will have difference is likely to lie between a lower and an upper
a likelihood of being met as determined by agreement, equivalence margin of clinically acceptable differences.
algorithm, or other specified process.
eSignature: See Electronic signature.
Enrollment: 1. The act of enrolling one or more subjects.
2. The class of enrolled subjects in a clinical trial. eSource: Source record that is electronic.

Enterprise Vocabulary Services (EVS): A US national eSource data (electronic source data): Source data
resource to house and maintain a number of health- captured initially into a permanent electronic record used
related glossaries and controlled vocabularies under strict for the reconstruction and evaluation of a clinical study.
versioning. Note: “Permanent” in the context of these definitions
implies that any changes made to the electronic data are
Epidemiology: The branch of medical science that deals recorded via an audit trail.
with the study of incidence, distribution and control of a
disease in a population. eSource document: The electronic record used to
aggregate a particular instance of eSource data items for
Epoch: Interval of time in the planned conduct of a study. capture, transmission, storage, and/or display, and serving
An epoch is associated with a purpose (e.g., screening, as a source document for a clinical investigation. Note:
randomization, treatment, follow-up), which applies Electronic source documents are recorded in electronic
across all arms of a study. Note: Epoch is intended as a systems according to conventions (such as those for PDF
standardized term to replace: period, cycle, phase, stage. documents) that ensure that all the fields of eSource data
and associated contextual information (e.g., time of capture,
ePRO: PRO data initially captured electronically. Note: time zone, authorship, signatures, revisions) are linked to
Usually ePRO data is captured as eSource.
each other in a particular structure for presentation. The
Equipment (research): Any item (or interrelated collection encoded specifications in the electronic record thus serve
of items comprising a system) of nonexpendable tangible the same role as have the physical properties of paper
property, having a useful life of more than 1 year and a (binding items together). eSource documents are subject to
cost of $2,000 or more, which is used wholly or in part for regulations and guidance that apply to source documents.
research. Note that all three conditions must be met for an Essential documents: Documents that individually and
item to be considered equipment, i.e.: 1. Nonexpendable collectively permit evaluation of the conduct of a study and
tangible property; 2. Useful life of more than 1 year; and,
the quality of the data produced.
3. A cost of $2,000 or more. To be considered materials
or supplies an item must meet only one of the following Established name: The official name of a drug substance.
conditions: 1. Expendable tangible property; or, 2. Useful Ethics Committee (EC): Independent reviewing body that
life of 1 year or less; or, 3. A cost of less than $2,000, considers and approves/disapproves biomedical research
excluding the non-reimbursable portion of taxes. For involving human subjects. Ethics Committee approval
example, a laptop computer that costs less than $2,000 is required for each clinical study protocol and Principal
would be considered as materials or supplies even though it Investigator prior to study initiation.
is a nonexpendable tangible item with a useful life of more
than one year. Ethics Committees: Bodies convened to protect human
clinical research subjects’ work under a variety of other
Equipoise: A state in which an investigator is uncertain names. For convenience and consistency, Applied Clinical
about which arm of a clinical trial would be therapeutically Trials generally uses the terms institutional review board
superior for a patient. Note: An investigator who has and ethics committee. Other names and abbreviations for

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