Glossary

Glossary Clinical Trials

Adverse Event Any undesirable medical occurrence such as sign, symptom or disease in a patient for whom investigational drug was administered regardless direct causal relationship with the drug.
Audit Sponsor's inspection of activities and documents for a clinical trial in order to determine whether the clinical trial was conducted according to the protocol and GCP, for the purpose of ensuring reliability of clinical trial.
Audit Certificate A certificate by an auditor showing that an audit has taken place.
Audit Report A report by the sponsor's auditor regarding results of audit.
Audit Trail Documentation that allows reconstruction of the course of events.
Case Report Form (CRF) Documents describing source document data and evaluation by the Investigator or Sub investigator on a subject in a clinical trial.
Central Monitoring An exceptional way of monitoring used for a clinical trial of which methodology of the clinical trial is simple but it is difficult to visit investigational sites because of large number of trial sites and their geographical distribution. The following means are used in combination;
(1) Meetings with investigators, subinvestigators and clinical research staffs for those trial participants, training regarding trial is provided in addition to detailed procedures regarding a clinical trial.
(2) Sampling of data and verification by statistically controlled method.
(3) Communication with investigator through telephone, facsimile, or other means.
Clinical Research Staff Any pharmacists, nurses and other medical license holders who cooperate in the conduct of the clinical trial under supervision of Investigator or Subinvestigator at a clinical site.
Clinical Study Report A written description of a trial/study in which the objective, methodology and results of a clinical trial are fully integrated into a single report after completion of a clinical trial.
Clinical Trial System Structures of clinical trial consisting from organizations, facilities and equipments of a sponsor, investigational sites and other institutions involved in a clinical trial, in order to ensure quality assurance and quality control of a clinical trial.
Contract Research Organization (CRO) A Person or an organization (commercial, academic. or other) contracted by the sponsor to perform one or more of a sponsor's trial related jobs.
Control drug An investigational or marketed product (i.e., active control), or placebo, used as a reference in a clinical trial
Coordinating Committee A committee that a sponsor may organize to coordinate the conduct of a multicentre trial constituted of a coordinating investigator and others.
Coordinating Investigator A physician or a dentist assigned by a sponsor who has responsibility for coordinating investigators at different sites in a multicentre trial.
Data and Safety Monitoring Board/ Independent Data-Monitoring Committee (IDMC) Data and Safety Monitoring Board/Independent Data-Monitoring Committee (IDMC) IDMC may be established by a sponsor to assess clinical trial at an appropriate intervals regarding its progress , including data for safety and major efficacy endpoints, and to recommend to a sponsor whether to continue, modify, or stop a trial. This committee is independent of a sponsor, an investigator and a coordinating investigator.
Impartial Witness A person, who is independent of the trial, who cannot be unfairly influenced by people involved in the trial, and who attends the informed consent process if the subject or the subject's legally acceptable representative cannot read, and who reads the informed consent form and any other written information supplied to the subject.
Informed Consent A voluntary confirmation by a subject through his or her own willingness to participate in a particular trial, after having been informed of all aspects of the trial, those are relevant to the subject's decision to participate. Informed consent is documented in an informed consent form.
Institutional Review Board (IRB) A body constituted of medical, dental, pharamaceuitical experts and other non-scientific members, independent of the director of a hospital, the investigator and the sponsor.
Investigational Drug Investigational New Drug and Control drug
Investigational New Drug A pharmaceutical form of an active ingredient for which a clinical trial is conducted
Investigational site Any public or private entity or agency or medical or dental facility where clinical trials are conducted.
Investigator A medical doctor or dentist responsible for the conduct of the clinical trial at a trial site.
Legally Acceptable Representative A person who exercise parental authority, a spouse or a guardian
Manager of Investigational Drug A pharmacist in principle, or a doctor or a dentist, who is designated by director of an investigational site, and stores investigational drug and maintain proper storage.
Monitoring Sponsor's act of overseeing the progress of a clinical trial, and ensuring that the clinical trial is conducted in accordance with the protocol, SOPs and GCP.
Nonclinical Tests Biomedical and other tests not involving human subjects.
Protocol A document that describes the objective(s), design, methodology, statistical review, and organization of a trial.
Randomization A process of assigning subjects to treatment or control group in order to reduce bias.
Source Data Verification (SDV) Permission to examine, analyze, verify, and reproduce any records and reports that are important to evaluation of a clinical trial. Any parties such as, regulatory authorities, sponsor's monitors and auditors who perform SDV must take all reasonable cautions in order to maintain confidentiality of subjects' identities and sponsor's proprietary information.
Source Documents Original documents, data, and records regarding administration of the investigational drug and treatment for a trial subject.
Sponsor An individual, company, institution, or organization which takes responsibility for the initiation, management, and/or financing of a clinical trial.
Subinvestigator Any doctor or dentist of the clinical trial team designated and supervised by the investigator at a trial site to perform clinical trial related procedures.
Subject Identification Code A unique code assigned by investigators for subject in order to prevent subjects from being identified and used in place of subject's name and address when investigators reports adverse events and/or other trial information.
Subject/Trial Subject Any individual who participates in a clinical trial, either as treatment group or a control group
Unanticipated Adverse Drug Reaction An adverse reaction, of which nature or severity is not consistent with the applicable product information such as Investigator's Brochure for an unapproved investigational product or documented safety information.
Vulnerable Subjects Individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation of benefits associated with participation or of a retaliatory response from senior members of a hierarchy in response to refusal to participate.

Abbreviations

ADR Adverse Drug Reaction
AE Adverse Event
AUC area under the curve
CIOMS Form Council for International Organization for Medical Science
CRA Clinical Research Associate
CRC Clinical Research Coordinator
CRF Case Report Form
CRO Contract Research Organization
GCP Good Clinical Practice
GLP Good Laboratory Practice
IC Informed Consent
IRB Institutional Review Board
SAE Serious Adverse Events
SDV Source Documents Verification
SMO Site Management Organization
SOP Standard Operational Procedure