Page 20 - Terminology-Clinical-Research

active ingredient, the non-proprietary name, or a brand depending on regulatory context and particularly in the
name. case of postmarketing commitments, a study might not
be the appropriate word for a clinical trial (prospective,
Drug product: 1. A dosage form that contains an active controlled, randomized), but should be reserved instead
drug ingredient or placebo. 2. A finished dosage form as for surveillance, structured gathering of information,
described in regulations. epidemiological studies, or even animal studies [DRAFT
Guidance for Industry Postmarketing Studies and Clinical
Drug: 1. Article other than food intended for use in the Trials—Implementation of Section 505(o) of the Federal
diagnosis, cure, mitigation, treatment, or prevention Food, Drug, and Cosmetic Act]. Synonyms: eClinical study,
of disease; or intended to affect the structure or any eClinical investigation.
function of the body. Not a device or a component, part,
or accessory of a device. 2. Substance recognized by an eCRF: 1. Auditable electronic record designed to capture
official pharmacopeia or formulary. information required by the clinical trial protocol to be
reported to the sponsor on each trial subject. 2. A CRF in
Drug-drug interaction: A modification of the effect of which related data items and their associated comments,
a drug when administered with another drug. The effect notes, and signatures are linked electronically. Note: eCRFs
may be an increase or a decrease in the action of either
substance, or it may be an adverse effect that is not may include special display elements, electronic edit
checks, and other special properties or functions and are
normally associated with either drug.
used for both capture and display of the linked data.
DSMB/C: Data Safety Monitoring Board/Committee.
eCRT: CRTs provided in electronic format for
Duration of response (DR): Time from confirmation of eSubmissions (electronic regulatory submissions). Note:
a partial response (PR), complete response (CR) or stable According to FDA guidance, eCRTs are datasets provided
disease (SD), until the disease has been shown to progress as SAS Transport files with accompanying documentation
following treatment (progressive disease or PD). in electronic submissions. They enable reviewers to analyze
each dataset for each study. Each CRF domain should be
Dynamic HTML: Collective term for a combination of provided as a single dataset; however, additional datasets
tags and options, style sheets, and programming that allows suitable for reproducing and confirming analyses may also
users to create web pages in Hypertext Mark-up Language be needed. Becoming obsolete, being replaced by SDTM.
(HTML) that are more responsive to user interaction than
previous versions of HTML. Edit check: An auditable process, usually automated, of
assessing the content of a data field against its expected
logical, format, range, or other properties that is intended
to reduce error. Note: Time-of entry edit checks are a type
E of edit check that is run (executed) at the time data are
first captured or transcribed to an electronic device at the
time entry is completed of each field or group of fields on
a form. Back-end edit checks are a type that is run against
data that has been entered or captured electronically and
EC: See Ethics Committee
has also been received by a centralized data store.
eCertified copy: A copy of an electronic record that is
created through the application of a process validated to EEA: European Economic Area.
preserve the data and metadata of the original and where Effect: An effect attributed to a treatment in a clinical trial.
the validation of the process is certified by the dated In most clinical trials, the treatment effect of interest is a
signature of an authorized person. comparison (or contrast) of two or more treatments.

eClinical trial: Clinical trial in which primarily Effectiveness: The desired measure of a drug’s influence
electronic processes are used to plan, collect (acquire), on a disease or condition as demonstrated by substantial
access, exchange, and archive data required for conduct, evidence from adequate and well-controlled investigations.
management, analysis, and reporting of the trial. Note:
FDA has recently drawn a distinction between studies Efficacy: The capacity of a drug or treatment to produce
and trials. Both words refer to systematic efforts to beneficial effects on the course or duration of a disease
obtain evidence relevant to regulatory authorities, but, at the dose tested and against the illness (and patient

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