Page 24 - Terminology-Clinical-Research

use in humans, or as a treatment for a particular condition. Field: Locus on a data collection instrument (usually a
CRF) for recording or displaying a data element.
Experimental group: The group of subjects exposed to the
new, researched treatment. This group is often compared to File Transfer Protocol (FTP): A standard protocol for
a ‘control group’, the subjects who are not exposed to that exchanging files between computers on the Internet.
treatment.
Final report: A written description of a trial/study of any
Experimental/investigational drug: A drug that has been therapeutic, prophylactic, or diagnostic agent conducted
authorized for use in a clinical trial but has not been granted in human subjects, in which the clinical and statistical
marketing approval as a treatment for a particular use. description, presentations, and analyses are fully integrated
into a single report.
Exploratory IND study: A clinical study that is conducted
early in Phase 1; involves very limited human exposure Finding: A meaningful interpretation of data or
and has no therapeutic or diagnostic intent (e.g., screening observations resulting from planned evaluations. Compare
studies, microdose studies). to conclusion, hypothesis.

Exploratory study: Phase 1 or 2 study during which First human administration: See First-in-human study.
the actions of a therapeutic intervention are assessed and
measured. Note: Procedures in exploratory studies may First received date: The First Received date is the date on
appropriately be altered to expand the scope or method of which summary clinical study protocol information was
investigation. Compare to confirmatory study. first submitted to the ClinicalTrials.gov registry. There is
typically a delay of a few days between the First Received
Extraction transformation load (ETL): A class of date and when the study information is available on
software applications for data extraction, transformation, ClinicalTrials.gov.
and loading that are used to implement data interfaces
between disparate database systems, often to populate data First subject in (FSI, FPI): The date and time the first
warehouses. subject is enrolled and randomized into a study. The subject
will have met the inclusion/exclusion criteria to participate
Extractive medicinal product: A medicinal product in the trial and will have signed an informed consent form.
derived from human tissue such as blood or plasma. Synonym: first patient in.
First subject screened: First subject who signs the
informed consent form and is screened for potential
F enrollment and randomization into a study but has not yet
been determined to meet the inclusion/exclusion criteria for
the trial.

First subject treated: First subject who receives the test
Factorial design: Describes a clinical study in which article or placebo in a clinical investigation.
groups of participants receive one of several combinations
of interventions. Note: For example, a two-by-two factorial First-in-human study: A clinical trial where a medical
design involves four groups of participants. Each group procedure or medicinal product, previously developed and
receives one of the following pairs of interventions: 1) drug assessed through laboratory model or animal testing, or
A and drug B, 2) drug A and a placebo, 3) a placebo and through mathematical modeling is tested on human subjects
drug B, or 4) a placebo and a placebo. So during the trial, for the first time.
all possible combinations of the two drugs (A and B) and
the placebos are given to different groups of participants. First-in-man study: See First-in-humans study.
One type of intervention model (design). First-line/second-line: The ‘line’ of treatment describes
the order in which it is tried as a therapy for cancer. A first-
FDA: Food and Drug Administration.
line treatment is the initial treatment used to target tumors.
FDAAA 801: Section 801 of the Food and Drug Second-line treatment is given when first-line therapy
Administration Amendments Act of 2007 (U.S. Public Law doesn’t work or stops working.
110-85).
Food and Drug Administration (FDA): An agency within
the U.S. Department of Health and Human Services. FDA

24 AlphaScienceLabs.com