THE INFLUENCE OF THE REGULATORY SYSTEM ON THE STUDY DESIGN AND DATA MANAGEMENT PRACTICES IN CLINICAL TRIALS
Author:
Affiliation:
1. NATIONAL UNIVERSITY OF “KYIV-MOHYLA ACADEMY”, KYIV, UKRAINE
2. BOGOMOLETS NATIONAL MEDICAL UNIVERSITY, KYIV, UKRAINE
Abstract
Publisher
ALUNA
Subject
General Medicine
Reference28 articles.
1. 1. Kornatskyi V., Talaieva T., Silantieva O. Pravovi problemy klinichnykh vyprobuvan likarskykh zasobiv v Ukraini [Legal problems of clinical trials of medicines in Ukraine]. Bulletin of the Academy of Advocacy of Ukraine. 2012;2(2):39–45. (In Ukrainian).
2. 2. World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. JAMA. 2013;310(20):2191–2194. doi:10.1001/jama.2013.281053.
3. 3. United Nations (General Assembly). International Covenant on Civil and Political Rights. Treaty Series. 1966;999:171–345.
4. 4. Convention for the Protection of Human Rights and Dignity of the Human Being with Regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine. J Med Philos. 2000;25(2):259-266. doi: 10.1076/0360-5310(200004)25:2;1-O;FT259.
5. 5. Konstytutsiia Ukrainy 1996 [Constitution of Ukraine 1996]. Vidomosti Verkhovnoi Rady Ukrainy. 1996; 30:142. (In Ukrainian).
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