EXTENSION OF THE DEADLINE OF THE DEROGATION FOR VISITS WITH MONITORS/AUDITORS DURING THE PANDEMIC

Posted by aicro
On 15 March 2022
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AIFA, at the request of the AICRO and Assomonitor Board, grants a further waiver to the certification procedures for new CRAs, maintaining the scheme of 3 on-site and 7 remote visits, until 30 September 2022. The note was published on 14/03/2022 on the AIFA website. Read more

2nd AICRO report on the state of CROs in Italy

Posted by aicro
On 11 March 2022
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AICRO publishes the 2nd report on the state of CROs in Italy, to find out the size of the sector, the number of employees, the turnover produced and the investments made. Read more

AIFA – OPERATIONAL PROPOSAL FOR TEMPORARY MANAGEMENT OF TRIALS UNDER REGULATION 536/2014

Posted by aicro
On 1 February 2022
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AIFA publishes a guideline for the management of clinical trials pending implementation decrees Leggi qui

CONDUCTING A SURVEY TO QUANTIFY THE PRESENCE OF DATA MANAGERS/STUDY COORDINATORS INVOLVED IN CLINICAL RESEARCH IN ITALY

Posted by aicro
On 26 January 2022
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Published the data of the activity aimed at quantifying the presence, in a sample of Italian hospitals, of professional figures (Clinical Research Coordinator/Data Manager) supporting clinical research, in the international journal “Journal of Clinical and Translational Science” (open access). Read the article

THE NATIONAL COORDINATION CENTRE OF ETHICS COMMITTEES APPROVES NEW DOCUMENTS IN ANTICIPATION OF THE APPLICATION OF REGULATION (EU) NO 536/2014

Posted by admin
On 19 January 2022
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The National Coordination Centre of Ethics Committees for Clinical Trials on Medicinal Products for Human Use and Medical Devices has published documents in anticipation of the implementation of Regulation (EU) No 536/2014 and available at the following link: https://www.aifa.gov.it/-/il-centro-di-coordinamento-nazionale-dei-comitati-etici-approva-nuovi-documenti-in-vista-dell-applicazione-del-regolamento-ue-n.-536/2014 The approved documents can be viewed in the related documents section at the following link: https://www.aifa.gov.it/centro-coordinamento-comitati-etici