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000251816/01/2019DGDMFMDSPMinistero Della Salute DIRECTION GENERAL DEI DISPOSITIVE MEDICI E DEL SERVILLO PHARMACEUTICS Office 3 Viable Giorgio Ricotta, 500144 Romped: AFDM postage. Santa.itDGDMF.3/I.1.b.f.3.1/2018/14AllOrganismo
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ECM - Notifica Invio is a notification sent to the Italian Ministry of Health to report the start of a clinical trial.
The sponsor or legal representative of the sponsor is required to file ECM - Notifica Invio.
ECM - Notifica Invio can be filled out online through the dedicated platform provided by the Italian Ministry of Health.
The purpose of ECM - Notifica Invio is to inform the Ministry of Health about the commencement of a clinical trial in Italy.
ECM - Notifica Invio must include information such as the protocol of the clinical trial, the investigational medicinal product, and the investigator's details.
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