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10.1016/j.conctc.2021.100837 http://scihub22266oqcxt.onion/10.1016/j.conctc.2021.100837 34423173!8372446!34423173     free     free     free       Contemp+Clin+Trials+Commun 2021 ; 23 (ä): 100837 Nephropedia Template TP {{tp|p=34423173|t=2021. Festina lente |pdf=|usr=}}{{34423173}} gab.com Text Festina lente JO: Contemp Clin Trials Commun http://www.kidney.de/pget.php?&tw=1&pmid=34423173 #FOAvip The provisions adopted in Italy for clinical trials on medicinal products and medical devices for the epidemiological emergency caused by COVID-19 had an impact also on the functioning of Ethics Committees (ECs). All COVID-19 clinical trials are evaluated preliminarily by the Technical Scientific Committee of the Italian Medicines Agency (AIFA). They are then evaluated by the Clinical Trial Office of the Competent Authority (AIFA) and by the EC of the Lazzaro Spallanzani National Institute for Infectious Diseases. On the basis of this experience, several parties have recommended the adoption of a new structure that envisages the involvement of a single EC for the activation of new studies, similar to the system put in place for studies on COVID-19. Rather than a single EC with jurisdiction over the entire country, we could envisage the accreditation of a certain number of ECs, possibly subdivided by therapeutic fields, with the trials to be evaluated distributed among them, so that each is authorised to issue an opinion that is valid nationally. Twit Text FOAVip Festina lente ????Contemp Clin Trials Commun http://www.kidney.de/pget.php?&tw=1&pmid=34423173 #FOAvip Twit Text # Free Paper on # # # # # LINK http://www.kidney.de/pget.php?&tw=1&pmid=34423173 #FOAvip English Wikipedia <ref>{{Cite pmid|34423173}}</ref> Festina lente #MMPMID34423173 Petrini C; Ricciardi W Contemp Clin Trials Commun 2021[Sep]; 23 (ä): 100837 PMID34423173show ga The provisions adopted in Italy for clinical trials on medicinal products and medical devices for the epidemiological emergency caused by COVID-19 had an impact also on the functioning of Ethics Committees (ECs). All COVID-19 clinical trials are evaluated preliminarily by the Technical Scientific Committee of the Italian Medicines Agency (AIFA). They are then evaluated by the Clinical Trial Office of the Competent Authority (AIFA) and by the EC of the Lazzaro Spallanzani National Institute for Infectious Diseases. On the basis of this experience, several parties have recommended the adoption of a new structure that envisages the involvement of a single EC for the activation of new studies, similar to the system put in place for studies on COVID-19. Rather than a single EC with jurisdiction over the entire country, we could envisage the accreditation of a certain number of ECs, possibly subdivided by therapeutic fields, with the trials to be evaluated distributed among them, so that each is authorised to issue an opinion that is valid nationally. äFestina lente (epmc).pdf DeepDyve Pubget Overpricing