Good laboratory practice (GLP) is a quality system concerned with the organizational process and the conditions under which nonclinical studies on safety for human health and the environment are planned, performed, monitored, documented, reported, and archived.
(Guideline “Medicinal products. Good laboratory practice. ST-N MoHU:2008”, approved by Order of the Ministry of Health No. 95 of 16.02.2009)
Preclinical study audit – a comparison of the raw data of a preclinical study of a medicinal product with the corresponding data presented in the preclinical study report on the medicinal product, in order to determine the completeness and authenticity of the presentation of the raw data of the preclinical study and the conformity of the conduct of the study with the preclinical study protocol (plan) and standard operating procedures, to obtain additional information not reflected in the preclinical study report on the medicinal product, to assess the adequacy of the method of obtaining the raw data, and also the conformity of the conducted preclinical studies with the requirements of Good Laboratory Practice
(MoH order of 14.12.2009 No. 944)
Good Clinical Practice (GCP) – a standard for the planning, conduct, performance, monitoring, auditing and documentation of clinical trials, as well as for the processing and reporting of their results. It guarantees the credibility and accuracy of the data and results obtained, the protection of the rights and health of study subjects, and the observance of confidentiality with regard to them.
(Guideline "Medicinal Products. Good Clinical Practice. ST-N MOZU 42-7.0:2008", as amended by Order of the Ministry of Health No. 1169 of 26.09.2017)
Clinical audit of a clinical trial – a procedure of official review by the Center of the clinical trial materials (documents), premises, equipment and facilities, records, quality assurance systems and other resources related to the clinical trial, which may be located at a healthcare institution, laboratories, the sponsor's premises or a contract research organization, etc.
(Order of the Ministry of Health of Ukraine of 23.09.2009 No. 690 as amended)
Clinical audit of clinical trials of medicinal products is assigned to the State Enterprise "State Expert Center of the Ministry of Health of Ukraine"
(para. 1.4 of Section I of the Procedure for Conducting Clinical Trials of Medicinal Products and Expert Evaluation of Clinical Trial Materials, approved by MoH order No. 690 of 23.09.2009, as amended)
