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10.47162/RJME.61.1.34 http://scihub22266oqcxt.onion/10.47162/RJME.61.1.34 32747923!7728112!32747923     free     free     free Deprecated: Implicit conversion from float 211.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 211.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 211.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 211.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 211.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 211.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 211.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534       Rom+J+Morphol+Embryol 2020 ; 61 (1): 277-281 Nephropedia Template TP {{tp|p=32747923|t=2020. Ethical review of patient safety and public health in EU clinical trials legislation: impact of COVID-19 pandemic |pdf=|usr=}}{{32747923}} gab.com Text Ethical review of patient safety and public health in EU clinical trials legislation: impact of COVID-19 pandemic JO: Rom J Morphol Embryol http://www.kidney.de/pget.php?&tw=1&pmid=32747923 #FOAvip PURPOSE: The study considers the ethical review of the European Union (EU) clinical trials (CTs) legislation, namely the Clinical Trials Regulation (CTR) (EU) 2014?536, the Directive 2001?20?EC and the "Guidance on the management of clinical trials during the COVID-19 (coronavirus) pandemic" (GMCT) (version 3) issued on 28 April 2020 by the European authorities in the field. BACKGROUND: The Directive 2001?20?EC focuses the legal provisions for the conduct of CTs by acknowledging the screening role of the Ethics Committees (ECs) and of the national competent authorities (NCA) in the Member States (MS) to protect the CT subject and the personal data. CONTENT: The present article displays the ethical requirements for conducting, monitoring and reporting of the CTs by raising awareness on the: (i) new conceptual framework of the "clinical trial", "low-intervention clinical trial", "non-interventional study" and "ethics committee"; (ii) ethical considerations addressed in Part I and Part II of the assessment report; (iii) evaluation of the coronavirus disease 2019 (COVID-19) pandemic on the current regulatory framework. CONCLUSIONS: The CTR stimulates the EU clinical research and enables an independent control with regard to the respect of the interests of the CT subject. Twit Text FOAVip Ethical review of patient safety and public health in EU clinical trials legislation: impact of COVID-19 pandemic ????Rom J Morphol Embryol http://www.kidney.de/pget.php?&tw=1&pmid=32747923 #FOAvip Twit Text # Free Paper on # # # # # LINK http://www.kidney.de/pget.php?&tw=1&pmid=32747923 #FOAvip English Wikipedia <ref>{{Cite pmid|32747923}}</ref> Ethical review of patient safety and public health in EU clinical trials legislation: impact of COVID-19 pandemic #MMPMID32747923 Olimid AP; Olimid DA Rom J Morphol Embryol 2020[]; 61 (1): 277-281 PMID32747923show ga PURPOSE: The study considers the ethical review of the European Union (EU) clinical trials (CTs) legislation, namely the Clinical Trials Regulation (CTR) (EU) 2014?536, the Directive 2001?20?EC and the "Guidance on the management of clinical trials during the COVID-19 (coronavirus) pandemic" (GMCT) (version 3) issued on 28 April 2020 by the European authorities in the field. BACKGROUND: The Directive 2001?20?EC focuses the legal provisions for the conduct of CTs by acknowledging the screening role of the Ethics Committees (ECs) and of the national competent authorities (NCA) in the Member States (MS) to protect the CT subject and the personal data. CONTENT: The present article displays the ethical requirements for conducting, monitoring and reporting of the CTs by raising awareness on the: (i) new conceptual framework of the "clinical trial", "low-intervention clinical trial", "non-interventional study" and "ethics committee"; (ii) ethical considerations addressed in Part I and Part II of the assessment report; (iii) evaluation of the coronavirus disease 2019 (COVID-19) pandemic on the current regulatory framework. CONCLUSIONS: The CTR stimulates the EU clinical research and enables an independent control with regard to the respect of the interests of the CT subject. |*Ethical Review[MESH] |*Ethics, Research[MESH] |*Health Policy[MESH] |COVID-19[MESH] |Clinical Trials as Topic/*ethics/*legislation & jurisprudence[MESH] |Coronavirus Infections/*epidemiology/*therapy[MESH] |Ethics Committees[MESH] |European Union[MESH] |Humans[MESH] |Informed Consent[MESH] |Pandemics[MESH] |Patient Safety[MESH] |Pneumonia, Viral/*epidemiology/*therapy[MESH] |Public Health[MESH]Ethical review of patient safety and public health in EU clinical tria(epmc).pdf DeepDyve Pubget Overpricing