List of clinical trial terms used in accordance with the legislation of Ukraine

Ukrainian terminology is generally harmonized with international guidelines, yet in several occasions definitions are not the same. For example, informed consent is a process according to ICH GCP, yet it is decision (i.e. result) in view of Ukrainian regulatory. Currently list of clinical research related terminology contain terms from Procedure for Conducting Clinical Trials of Medicinal Products and Expert Evaluation of Materials Pertinent to Clinical Trials and Model Regulations of the Ethics Committees approved by the MoH Ukraine Order of 23.09.2009 No 690 (hereinafter Procedure).

Translation is aligned with ICH standards specifically ICH E6 and E2A.

Regulatory glossary

Adverse event
Any untoward medical occurrence in a subject which does not necessarily have to have a causal relationship with administration of medicinal product. An adverse event can be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of the (investigational) medicinal product, whether or not considered related to the (investigational) medicinal product.
Adverse reaction
In context of clinical trial of a medicinal product (original / generic) or study of its new usage, particularly if therapeutic doses of the medicinal product are not established, adverse reactions include all noxious and unintended responses to any dose of the medicinal product. The term “response to the administration of a medicinal product” means the presence of at least reasonable possibility of causality between the medicinal product and adverse reaction, i.e. the relationship cannot not be ruled out.
For the registered medicinal products this term means all noxious and unintended reactions associated with the use of medicinal product at doses normally used for the prophylaxis, diagnosis or therapy of diseases, rehabilitation, correction and modification of physiological function.
Applicant for clinical trial
A natural person or a legal entity (e.g., sponsor, contract research organization), who submits an application to the [State Expert] Center [of the Ministry of Health of Ukraine] for obtaining its conclusion on conduction of a clinical trial / on substantial amendment. Applicant who is not the sponsor must submit the application upon availability of Power of Attorney which contains explicitly defined powers granted by the sponsor.
Bioavailability
a rate and fraction of active substance or its active moiety absorbed (up-taken) from a pharmaceutical form and become available at the site of action
Bioequivalence
two medicinal products considered bioequivalent if they are pharmaceutically equivalent or pharmaceutically alternative and their bioavailability after the same molar dose administration are similar to extent that efficacy and safety effects of these products are essentially the same
Case Report Form (CRF)
a printed, electronic or optical document designed to record all of the clinical trial protocol required information to be provided to a sponsor on each trial subject
Clinical audit of clinical trial
A procedure of an official examination by the [State Expert] Center [of the Ministry of Health of Ukraine] of clinical trial materials (documents), facilities, equipment and instruments, records, safety and quality assurance systems and other resources related to a clinical trial and which may be available at a health care setting, laboratories, premises of the sponsor or the contract research organizations, etc.
Clinical study report
results of a clinical study and their analysis in writing
Clinical trial (study) of medicinal product
A research study those purpose is any investigation in humans as trial subjects to discover or to verify clinical, pharmacokinetic, pharmacodynamic and/or other effects including the study of absorption, distribution, metabolism and excretion of one or more investigational medicinal products and/or to detect adverse reactions to one or several investigational medicinal products with the purpose to assess its (their) safety and/or efficacy.
Clinical trial (study), multicentre
A trial of a medicinal product conducted according to a single clinical trial protocol at more than one trial site.
Clinical trial protocol
A document that describes the objectives, methodology, procedures, statistical aspects and organization of a clinical trial, including as a rule data obtained previously for the investigational medicinal product and rationale for the trial.
Clinical trial protocol, amendment to
A written description of changes or formal clarification of clinical trial protocol wording.
Clinical trial protocol, substantial amendment to
Amendment to a clinical trial protocol considered substantial in case it may have a significant impact on safety or on physical or mental integrity of a patient (healthy volunteer) who participates in the clinical trial, or affect scientific value of the trail.
Close relatives
natural persons, the natural relation between whom is based on origin from each other or from common ancestors, and having legal significance in cases envisaged by the legislation. Close relatives are husband/wife, parents, children, sibs
Contract research organization
a natural person or a legal entity which is acting in accordance with a contract made with a sponsor to perform one or more of its functions (powers) in a clinical trial, and which is acting under a Power of Attorney granted by the sponsor which contains explicitly defined powers
Ethics committee of health care setting
An independent body at health facility (health care setting) where clinical trials are conducted, constituted medical / scientific professionals, individuals of other specialties, representatives of the public, who oversee protection of the rights, safety, well-being of trial patients (healthy volunteers), ethical and legal principles of clinical trial conduction.
Based on evaluation of ethical and legal principles ethics committee of health facility (health care setting) agrees conduction of clinical trial at actual trial conduction site located at HCS where the committee composed and operated.
Expert evaluation of materials of clinical trial
review, analysis and assessment of a medicinal product clinical trial materials in order to prepare reasoned conclusion on conduction of a clinical trial / on substantial amendment
Health facility (health care setting, HCS)
a legal entity of any type of ownership and organization and legal form or its separate subdivision, the main task of which is to provide medical care based on an appropriate license and professional activity of medical (pharmaceutical) staff
Informed consent
A decision to participate in the clinical trial made in writing, dated and signed, freely given after having been duly informed of the clinical trial nature, its importance, impact and risk, appropriately documented by individual capable of giving consent, or by legal representative (close relative) of the person; in exceptional cases where individual is unable to write, the consent might be given orally in the presence of at least one witness who confirms the trial subject’s consent in written form.
Investigational medicinal product
a pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial, including products already with a registration certificate, but used or manufactured (formulated or packaged) in a way different from the registered pharmaceutical form, or when used for an unregistered indication, or when used to gain further information about the registered form of the medicinal product
Investigational medicinal product’s dossier
an information about the quality of each investigational medicinal product including a reference product and placebo, as well as data from preclinical studies and information about previous clinical trials or clinical use of the investigational medicinal product
Investigator/co-investigator
a physician with a sufficient proficiency and experience in patient care, aware of good clinical practice rules and applicable regulatory documents. Investigator is responsible for conduction of clinical trial of medicinal product at clinical trial site. If trial is conducted by a team of individuals at certain trial site, one of investigators is nominated as responsible study team leader and may be called the principal investigator
Investigator’s brochure
summary of preclinical and clinical data on the investigational medicinal product which is relevant to its study in human subject
Legal representatives
parents, adoptive parents, parent tutors, caregivers, trustees, representatives of tutorial and custodial authorities
Manufacturer of medicinal product
a legal entity performing at least one stage of medicinal product manufacturing, including packaging
Medicinal products
Substances or their combination of natural, synthetic or biotechnological nature that are intended for prevention of pregnancy, for prophylaxis, diagnosis and treatment of diseases in humans, or alter the state and functions of the organism.
Monitor
An individual assigned by a sponsor or contract research organization who controls conduction of the clinical trial in accordance with the protocol of clinical trial.
Non-interventional study
A study where medicinal products are given in usual way according to approved package insert. Study protocol does not provide assignment of a patient to a treatment group, while prescription of the medicinal product falls within current practice and separated from decision to include the patient into the study. No additional diagnostic or monitoring procedures applied to patients, and epidemiological techniques used for analysis of collected data.
Patient (healthy volunteer)
An individual who may participate as a trial subject in a clinical trial of medicinal product.
Qualified person (of a manufacturer)
a natural person assigned by a manufacturer who is responsible for ensuring that all batches of a medicinal product are manufactured in compliance with basic principles of good manufacturing practice, checked for compliance with a product specification, and release for sale or use in a clinical trial of each batch of a medicinal product
Serious adverse reaction or serious adverse event
Any untoward medical occurrence at administration of medicinal product (related to any dose) which is results in death; is life-threatening; requires hospitalization or prolongation of existing hospitalization, results in persistent or significant incapacity or disability; congenital anomaly or birth defect.
Source medical documents
Original documents, data and records (e.g., hospital charts, ambulatory charts, laboratory notes, memoranda, subjects’ diaries or evaluation checklists, pharmacy dispensing records, recorded data from automated instruments, verified and certified copies or transcripts of phonograms, microfiches, photographic negatives, microfilms or magnetic media, x-rays, administrative files, records kept at the pharmacy, at the laboratory and at the department of instrumental diagnostics for subjects that participates in the clinical trial, etc.).
Sponsor
A legal entity or a natural person which takes responsibility for the initiation and management of a clinical trial of the medicinal product and / or its financing.
Subject (trial subject)
A patient (healthy volunteer) who participates in a clinical trial according to the current procedure.
Subject identification code / number
A unique identifier assigned by investigator to each trial subject to ensure anonymity of the subject and used in lieu of the subject’s name in materials of clinical trial
Trial conduction site
A certain location where primary activities pertinent to a clinical trial (patients’ enrollment, treatment, observations, etc.) are conducted in a health care setting.
Unexpected adverse reaction
An adverse reaction, the nature or severity of which is not consistent with the applicable product information (e.g., investigator’s brochure for a non-registered medicinal product or package insert / summary of product characteristics for a registered medicinal product).

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