CONTRACTUAL REGISTRATION OF ORGANIZATIONAL AND LEGAL RELATIONS BETWEEN SUBJECTS INVOLVED IN THE CONDUCT OF CLINICAL TRIALS OF MEDICINAL PRODUCTS-Reference-Cited by-同舟云学术

CONTRACTUAL REGISTRATION OF ORGANIZATIONAL AND LEGAL RELATIONS BETWEEN SUBJECTS INVOLVED IN THE CONDUCT OF CLINICAL TRIALS OF MEDICINAL PRODUCTS

Published:2020 Issue:12 Volume:73 Page:2840-2847
ISSN:0043-5147
Container-title:Wiadomości Lekarskie
language:en
Short-container-title:Wiad Lek

Author:

Antoniuk Olena I.¹,Pavliuchenko Yuliia M.²,Vyshnyvetskyy Ivan I.³

Affiliation:

1. SUPREME COURT, KYIV, UKRAINE, UKRAINIAN ASSOCIATION FOR CLINICAL RESEARCH, KYIV, UKRAINE

2. VASYL' STUS DONETSK NATIONAL UNIVERSITY, VINNYTSIA, UKRAINE

3. BOGOMOLETS NATIONAL MEDICAL UNIVERSITY, UKRAINIAN ASSOCIATION FOR CLINICAL RESEARCH, KYIV, UKRAINE

Abstract

The aim: Determination of features of contractual registration of organizational and legal relations between the subjects involved in carrying out clinical trials of medicinal products; justification of proposals on improvement of law enforcement practice in this field. Materials and methods: This research is based on the analysis of the norms of international law and legislation of particular states, practice of contractual registration of organizational and legal relations between the subjects of clinical trials of medicinal products. The research was carried out using the methods of dialectical and formal logic, general scientific and special legal research methods. Conclusions: Two models of contractual registration of organizational and legal relations between the subjects involved in clinical trials of medicinal products were justified, and law enforcement recommendations for the contractual registration of such relationships, ensuring that the clinical trial is in compliance with international regulations and ethics in this field, were given.

Publisher

ALUNA

Subject

General Medicine

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