Terms

임상시험 용어
Subject Trial Subject
Subject/Trial Subject

A person who voluntarily participates in a clinical trial, and will take investigation products per protocol

Investigator A person responsible for the trial and for the rights, health and welfare of the subjects in the trial. The investigator should have qualifications and competence in accordance with local laws and regulations.
Investigational Product A pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial, including a product with a marketing authorization when used or assembled in a way different from the approved form, or when used for an unapproved indication, or when used to gain further information about an approved use.
Comparator An investigational or marketed product ( i. e. active control), or placebo, used as a reference in a clinical trial.
Active control An investigational product used as a reference in a clinical trial except for comparator.
Placebo A placebo is a substance that looks like a trial medication but does not containactive drug.
Randomization
(Randomization)
The process of assigning trial subjects to treatment or control groups using an element of chance to determine the assignments in order to reduce bias.
Monitoring
(Monitoring)
The act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported ethically and scientifically in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s).
Quality Assurance All those planned and systematic actions that are established to ensure that the trial is performed and the data are generated, documented (recorded), and reported in compliance with Good Clinical Practice (GCP) and the applicable regulatory requirement(s).
Quality Control The operational techniques and activities undertaken within the quality assurance system to verify that the requirements for quality of the trial-related activities have been fulfilled.
Institutional Review Board It is an independent body, constituted of medical professionals and non-medical members, whose responsibility is to ensure the protection of the rights, safety and well-being of human subjects involved in a trial. It provides reviewing and approving / providing opinion on the trial protocol, the suitability of the investigator(s), facilities, and the methods and material to be used in obtaining and documenting informed consent of the trial subjects.
Adverse Drug Reaction, ADR All noxious and unintended responses to a medicinal product related to any dose should be considered adverse drug reactions. Causal relationship between an investigational product and an adverse event is at least a reasonable possibility, i.e. the relationship cannot be ruled out.
Adverse Event Any untoward medical occurrence in a patient or clinical investigation subject administered an investigational product and which does not necessarily have a causal relationship with this treatment. An adverse event (AE) can therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of an investigational product, whether or not related to the investigational product.
Serious AE/ADR An event that is associated with death, admission to hospital, prolongation of a hospital stay, persistent or significant disability or incapacity, or is otherwise life-threatening in connection witha clinical trial.
Protocol A document that describes the objective(s), design, methodology, statistical considerations, and organization of a trial. The protocol usually also gives the background and rationale for the trial, but these could be provided in other protocol referenced documents.
Case Report Form, CRF A printed, optical, or electronic document designed to record all of the protocol required information to be reported to the sponsor on each trial subject.
Clinical Trial/Study Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational product(s), and/or to identify any adverse reactions to an investigational product(s), and/or to study absorption, distribution, metabolism, and excretion of an investigational product(s) with the object of ascertaining its safety and/or efficacy. The terms clinical trial and clinical study are synonymous.
Multi Center Trial
A clinical trial conducted according to a single protocol but at more than one site, and therefore, carried out by more than one investigator.