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Revista de Chimie, Volume 69, Issue 1, pp. 267-270 (2018)
https://doi.org/10.37358/RC.18.1.6086

Ionut Vida Simiti

Interventional Clinical and Chemical Studies in Romania, Legal Guarantees

Abstract:

The risks of medical treatment are due not only to the patient’s anatomic and physiological state, but also to the scientific and technical level of medicine when providing the medical service, which may progress through interventional clinical studies. In Romania, between 2012-2016 were issued annually between 192 and 221 authorizations for performing interventional clinical studies, the majority being phase III studies and almost half in oncological, respiratory and nervous diseases, although the pathology which represents the main mortality cause is the cardiovascular one. The goal of this study is the analysis of the legal requirements for the patients to participate to these interventional clinical studies, within the ample proceedings that aim to the approval of chemical substances as human use drugs. At present, the legal guarantees for interventional clinical studies are offered by the EU Regulation 536/2014 of the European Parliament and of the Council of 16 April 2014 regarding interventional clinical studies with drugs for human use, which through art. 4-27 of the Regulation settles a preliminary authorization procedure meant to avoid any deviation from public order and good morals, and through art. 28-36 of the Regulation protects the patient’s private interest through a special regulation of his consent when accepting an unusual clinical practice.
Keywords:
Interventional clinical studies; health care; patient rights; medical consent; medical legal liability; drugs

Issue: 2018 Volume 69, Number 1
Pages: 267-270
https://doi.org/10.37358/RC.18.1.6086
download pdf   Download Pdf Article
Citation Styles
Cite this article as:
SIMITI, I.V., , Rev.Chim., 69, no. 1, 2018, p. 267

Vancouver
Simiti IV. Interventional Clinical and Chemical Studies in Romania, Legal Guarantees. REV.CHIM.[internet]. 2018 Jan;69(1):267-270. Available from: https://doi.org/10.37358/RC.18.1.6086


APA 6th edition
Simiti, I.V., (2018). Interventional Clinical and Chemical Studies in Romania, Legal Guarantees. Revista de Chimie, 69(1), 267-270. https://doi.org/10.37358/RC.18.1.6086


Harvard
Simiti, I.V., (2018). 'Interventional Clinical and Chemical Studies in Romania, Legal Guarantees', Revista de Chimie, 69(1), pp. 267-270. https://doi.org/10.37358/RC.18.1.6086


IEEE
I.V. Simiti, "Interventional Clinical and Chemical Studies in Romania, Legal Guarantees". Revista de Chimie, vol. 69, no. 1, pp. 267-270, 2018. [online]. https://doi.org/10.37358/RC.18.1.6086


Text
Ionut Vida Simiti,
Interventional Clinical and Chemical Studies in Romania, Legal Guarantees,
Revista de Chimie,
Volume 69, Issue 1,
2018,
Pages 267-270,
ISSN 2668-8212,
https://doi.org/10.37358/RC.18.1.6086.
(https://revistadechimie.ro/Articles.asp?ID=6086)
Keywords: Interventional clinical studies; health care; patient rights; medical consent; medical legal liability; drugs


RIS
TY - JOUR
T1 - Interventional Clinical and Chemical Studies in Romania, Legal Guarantees
A1 - Simiti, Ionut Vida
JF - Revista de Chimie
JO - Rev.Chim.
PB - Revista de Chimie SRL
SN - 2668-8212
Y1 - 2018
VL - 69
IS - 1
SP - 267
EP - 270
UR - https://doi.org/10.37358/RC.18.1.6086
KW - Interventional clinical studies
KW - health care
KW - patient rights
KW - medical consent
KW - medical legal liability
KW - drugs
ER -


BibTex
@article{RevCh2018P267,
author = {Simiti Ionut Vida},
title = {Interventional Clinical and Chemical Studies in Romania, Legal Guarantees},
journal = {Revista de Chimie},
volume = {69},
number = {1},
pages = {267-270},
year = {2018},
issn = {2668-8212},
doi = {https://doi.org/10.37358/RC.18.1.6086},
url = {https://revistadechimie.ro/Articles.asp?ID=6086}
}
 
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