Page 11 - Terminology-Clinical-Research

Clinical study: See Clinical trial. the side effects of the treatment, and the cost.

Clinical trial (CT or interventional study): Clinical trials, Clinician reported outcome: Clinician assessment of
also known as clinical studies, test potential treatments in patient outcomes, based on objective or subjective data
human volunteers or patients to see whether they should evaluated by the clinician.
be further investigated or approved for wider use in the
general population. A treatment could be a drug, medical Closed studies: Clinical studies that are no longer
device, or biologic, such as a vaccine, blood product, or recruiting participants because they have enough
gene therapy. Potential treatments, however, must first participants already, have ended, or have been stopped
be studied in laboratory models or animals to determine for some reason. This term also describes studies with
its safety before they can be tried in people. Treatments very specific Eligibility Criteria that recruit participants
having acceptable safety profiles for the disease or by invitation only. Recruitment statuses for closed studies
condition and showing the most promise are then moved appear in red text in ClinicalTrials.gov search results and
into clinical trials. Clinical trials are an integral part of study records. These statuses are:
new product discovery and development, and are required
by all regulatory agencies (e.g., the Food and Drug • Active, not recruiting
Administration (FDA) in the United States), before a new • Completed
product can be brought to the market.
• Terminated
Clinical trial data: Data collected in the course of a
clinical trial. • Suspended

Clinical trial exemption (CTX): A scheme that allows • Withdrawn
sponsors to apply for approval for each clinical study in
turn, submitting supporting data to the Medicines Control • Enrolling by invitation
Agency (MCA), which approves or rejects the application
(generally within 35 working days). Note: Approval means • Temporarily not available for expanded access
that the company is exempt from the requirement to hold a • No longer available for expanded access
clinical trial certificate (CTC).
• Approved for marketing
Clinical trial information: Data collected in the course of
a clinical trial or documentation related to the integrity or Note: For closed studies, the word “Unknown,” in
administration of that data. A superset of clinical trial data. brown text, means that a study record with an Active, not
recruiting status has not been verified on ClinicalTrials.gov
Clinical trial materials: Complete set of supplies provided within the past 2 years.
to an investigator by the trial sponsor.
Codelist: Finite list of codes and their meanings that
Clinical Trials.Gov Identifier (NCT number): A represent the only allowed values for a data item.
unique identification code is given to each clinical study
registered on ClinicalTrials.gov. Because the format is Codding: In clinical trials, the process of assigning data to
“NCT” followed by an 8-digit number (for example, categories for analysis Note: Adverse events, for example,
NCT00000419), this identifier is also known as the NCT may be coded using MedDRA.
Number.
Cognitive debriefing: A qualitative research tool used to
Clinical: Pertaining to or founded on observation determine whether concepts and items are understood by
and treatment of human participants or patients, as patients in the same way that PRO instrument developers
distinguished from theoretical or basic science. intend. Note: Cognitive debriefing interviews involve
incorporating follow-up questions in a field test interview
Clinically significant: A result (e.g., a treatment effect) that to gain better understanding of how patients interpret
is large enough to be of practical importance to patients and questions asked of them and to collect and consider all
health care providers. The hypothesis of clinical studies is concepts elicited by an item.
usually based on clinical significant effect. This is not the
same thing as statistically significant. Assessing clinical Cohort: 1. A group of individuals who share a common
significance takes into account factors such as the size of a exposure, experience or characteristic. 2. A group of
treatment effect, the severity of the condition being treated,

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