Page 19 - Terminology-Clinical-Research

legal in the document. Note: Agreeing on a common DTD administration of individual doses.
facilitates interoperability among systems incorporating the
agreed standards. Dose dependent: A response to a drug that may be related
to the amount received (i.e., the dose). Sometimes trials
Documentation: All records, in any form (including but are done to test the effects of different dosages of the same
not limited to written, electronic, magnetic, and optical drug. This may be true for both benefits and harms.
records, and scans, x-rays, and electrocardiograms) that
describe or record the methods, conduct, and/or results of a Dose response: The dose-response describes the change
trial, the factors affecting a trial, and the actions taken. in effect caused by differing doses to a Medicinal
Product after a certain exposure time. This may apply to
Domain name: The way a particularweb server is individuals, or to populations.
identified on the Internet. For example, www.fda.gov
names the World Wide Web (www) server for the Food and Dose-ranging study: A clinical trial in which two or more
Drug Administration, which is a government (.gov) entity. doses of an agent (such as a drug) are tested against each
other to determine which dose works best and is least
Domain: A collection of observations with a topic-specific harmful.
commonality about each subject in a clinical investigation.
Note: Domains can be classified. For example, Dose: The amount of drug administered to a patient or test
Interventions class is a domain that captures investigational subject at one time or the total quantity administered.
treatments, therapeutic treatments, and surgical procedures
that are intentionally administered to the subject (usually Dose-dependent range: The relationship between the
for therapeutic purposes) either as specified by the study quantity of treatment given and its effect on outcome.
protocol (e.g., exposure), coincident with the study In meta-analysis, dose-response relationships can be
investigated using meta-regression.
assessment period (e.g., concomitant medications), or
other substances self-administered by the subject (such as Dose-escalation trial: A phase I trial in which the dose of a
alcohol, tobacco, or caffeine). The Events class captures drug is periodically increased or decreased as new subjects
occurrences or incidents independent of planned study are added.
evaluations occurring during the trial (e.g., “adverse
events” or “disposition”) or prior to the trial (e.g., “medical Double blind masking (study): A study in which neither
history”). The Findings class captures the observations the subject nor the investigator nor the research team
resulting from planned evaluations such as observations interacting with the subject or data during the trial knows
made during a physical examination, laboratory tests, what treatment a subject is receiving.
ECG testing, and sets of individual questions listed on
questionnaires. Double blind: See Double blind masking.

Dosage form: Physical characteristics of a drug product, Double-dummy: A technique for retaining the blind when
(e.g., tablet, capsule, or solution) that contains a drug administering supplies in a clinical trial, when the two
substance, generally—but not necessarily—in association treatments cannot be made identical. Supplies are prepared
with one or more other ingredients. for Treatment A (active and indistinguishable placebo) and
for Treatment B (active and indistinguishable placebo).
Dosage regimen: The number of doses per given time Subjects then take two sets of treatment; either A (active)
period; the elapsed time between doses (for example, every and B (placebo), or A (placebo) and B (active).
six hours) or the time that the doses are to be given (for
example, at 8 a.m. and 4 p.m. daily); and/or the amount of a Dropout: A subject in a clinical trial who for any reason
medicine (the number of capsules, for example) to be given fails to continue in the trial until the last visit or observation
at each specific dosing time. required of him/her by the study protocol.

Dosage strength: 1. Proportion of active substance to Drug development process: The program for advancing
excipient, measured in units of volume or concentration. 2. an investigational product from preclinical studies through
The strength of a drug product tells how much of the active approval for marketing following review by regulatory
ingredient is present in each dosage. agencies.

Dosage: The amount of drug administered to a patient or Drug name: Name given to the drug used in the clinical
test subject over the course of the clinical study; a regulated trial. This may be a code name, the chemical name of the

TERMINOLOGY CLINICAL RESEARCH 19