Page 5 - Terminology-Clinical-Research

organizations as American National Standards, acting as the Application software: See application.
US representative in international and regional standards
efforts, and serving as a clearinghouse for national and Application: 1. Computer application: software designed
international standards development information. to fill specific needs of a user; for example, software
for navigation, project management, or process control.
Analysis dataset: An organized collection of data or 2. Regulatory application: application made to a health
information with a common theme arranged in rows and authority to investigate, market, or license a new product or
columns and represented as a single file; comparable to indication.
a database table. Note: Standardizing analysis datasets is
intended to make review and assessment of analysis more Approvable letter: An official communication from FDA
consistent. to an NDA/BLA sponsor that lists issues to be resolved
before an approval can be issued.
Analysis set: A set of subjects whose data are to be
included in the main analyses. This should be defined in the Approval letter: An official communication from FDA
statistical section of the protocol. Note: There are a number to inform an applicant of a decision to allow commercial
of potential analysis sets, including, for example, the set marketing consistent with conditions of approval.
based upon the intent-to-treat principle.
Approval: A drug, device or biologic must be approved by
Analysis variables: Variables used to test the statistical a country’s regulatory agency before it can be marketed.
hypotheses identified in the protocol and analysis plan; The approval process involves several steps including
variables to be analyzed. pre-clinical (animal) studies, clinical trials for safety and
efficacy, filing of a New Drug Application (NDA) in the
Analyte: A substance being analyzed; in chromatography, a United States or Marketing Authorization Application
single component (compound) of a mixture. (MAA) in Europe by the manufacturer, regulatory agency
review of the application, and agency approval/rejection of
Anchor: Designation for a planned activity, often marking application.
the transition between epochs or elements of a clinical
study plan (e.g., “FPFV—first patient first visit”). Approved drugs: In the United States the FDA must
approve drugs through a process that involves several
Anonymized: Personal data which have been processed to steps, including preclinical laboratory and animal studies,
make it impossible to know the person with whom the data investigational new drug (IND) application to start clinical
are associated. Applicable particularly for secondary use of trials for safety and efficacy, and fi ling of a new drug
health data. application (NDA) by the manufacturer of the drug. The
drug is approved after the FDA approves the NDA.
ANSI: See American National Standards Institute.
Archived funding opportunity: A funding opportunity
APB: Administrative Panel on Biosafety.
whose application deadline date has passed.
Applet: A small application, typically downloaded from a Arm: A group or subgroup of participants in a clinical
server.
trial that receives specific interventions, or no intervention,
Applicable regulatory requirement(s): Any law(s) and according to the study protocol. This is decided before the
regulation(s) addressing the conduct of clinical trials of trial begins.
investigational products of the jurisdiction where trial is
conducted. Arm type: A general description of the clinical study arm.
It identifies the role of the intervention that participants
Application of knowledge (ethically-sound): Ethically- will receive. Types of arms include Experimental, Active
sound KT (knowledge translation) activities for improved Comparator, Placebo Comparator, Sham Comparator, and
health are those that are consistent with ethical principles No Intervention.
and norms, social values, as well as legal and other
regulatory frameworks - while keeping in mind that Assent: A child’s consent to participate in a clinical trial.
principles, values and laws can compete among and Assessment: A measurement, evaluation, or judgment for
between each other at any given point in time. The term a study variable pertaining to the status of a subject. Note:
application is used to refer to the iterative process by which Assessments are usually measured at a certain time, and
knowledge is put into practice. usually are not compounded significantly by combining

TERMINOLOGY CLINICAL RESEARCH 5