Page 63 - Terminology-Clinical-Research

phase. Note: 2. Software verification looks for consistency,
completeness, and correctness of the software and its
supporting documentation, as it is being developed, W
and provides support for a subsequent conclusion that
software is validated [FDA General Principles of Software
Validation; ANSI/ASQC A3-1978; ISO/IEC Guide 25].
Verification is used in the sense of matching elements
of a report or results of system testing to individual Warning letter: A written communication from FDA
requirements. notifying an individual or firm that the agency considers
one or more products, practices, processes, or other
Verification of data: See Source document verification activities to be in violation of the Federal FD&C Act, or
(SDV). other acts, and that failure of the responsible party to take
appropriate and prompt action to correct and prevent any
Verification date: The Last Verified date is the most recent future repeat of the violation may result in administrative
date on which all of a clinical study’s information on and/or regulatory enforcement action without further
ClinicalTrials.gov was confirmed as accurate and current. notice.
This date may be different from the Last Updated date. If
a study with a status of Recruiting; Not yet recruiting; or Washout period: A period in a clinical study during which
Active, not recruiting has not been confirmed within the subjects receive no treatment for the indication under study
past 2 years, the study’s Recruitment status is shown as and the effects of a previous treatment are eliminated (or
Unknown. assumed to be eliminated).

Version (MedDRA): The version of MedDRA terminology Web browser: A computer program that interprets HTML
used. and other Internet languages and protocols and displays
web pages on a computer monitor.
Visit: A clinical encounter that encompasses planned and
unplanned trial interventions, procedures, and assessments Web page: A single page on a website, such as a home
that may be performed on a subject. A visit has a start and page.
an end, each described with a rule.
Web server: A computer server that delivers HTML pages
Vocabulary: Terms that function in general reference to or files over the World Wide Web.
concepts that apply over a variety of languages are words,
and their totality is a vocabulary. Synonym: terminology. Website: A collection of web pages and other files. A site
can consist of a single web page, thousands of pages, or
Volunteer: A person volunteering to participate as a custom created pages that draw on a database associated
subject in a clinical trial, often a healthy person agreeing to with the site.
participate in a Phase 1 trial.
Weighting: An adjustment in a value based on scientific
Vulnerable subjects: Individuals whose willingness to observations within the data.
volunteer in a clinical trial may be unduly influenced by the
expectation, whether justified or not, of benefits associated Well-being (of the trial subjects): The physical and
with participation, or of a retaliatory response from senior mental integrity of the subjects participating in a clinical
members of a hierarchy in case of refusal to participate. trial.
Examples are members of a group with a hierarchical WHO (UTN): World Health Organisation Universal
structure, such as medical, pharmacy, dental, and nursing Trial Number. The UTN is a number, obtained by the
students, subordinate hospital and laboratory personnel,
employees of the pharmaceutical industry, members of trial’s sponsor or principal investigator and is used for the
identification of clinical trials worldwide.
the armed forces, and persons kept in detention. Other
vulnerable subjects include patients with incurable diseases, Withdrawal: The subject-initiated act of discontinuing
persons in nursing homes, unemployed or impoverished participation in a clinical study. Note: Withdrawal can
persons, and patients in emergency situations, ethnic range from the subject’s complete withdrawal from study
minority groups, homeless persons, nomads, refugees, procedures and follow-up activities, to the subject’s
minors, and those incapable of giving consent. withdrawal from study-related interventions while the
subject permits continued access to his/her medical records

TERMINOLOGY CLINICAL RESEARCH 63