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Ethics Committees Coordination Centre
The National Coordination Centre of Local Ethics Committees for clinical trials on medicinal products for human use and medical devices, provided for by Art. 2 of Law 11 January 2018, no. 3, is established at AIFA and its composition is governed by the Decree of the Minister of Health of 19 April 2018.
With an aim to guarantee homogeneity of procedures and compliance with the deadlines, the Centre coordinates, directs and monitors the evaluation activities of the ethical aspects relating to clinical trials on medicinal products for human use and medical devices delegated to the local ethics committees.
The Decree of the Minister of Health dated 27/05/2021 provided for the reconstitution of the Coordination Centre.
Appointed members:
- Carlo Maria Petrini (President)
- Gianni Tognoni (Vice President)
- Maria Luisa Moro
- Giuseppe Remuzzi
- Maria Platter
- Tommasina Iorno
- Angelo Ricci
- Giovanni Barosi
- Paolo Bruzzi
- Mario Guerrieri
- Agostino Migone De Amicis
- Renzo Pegoraro
- Patrizia Popoli
- Franco Rossi
- Antonella Eliana Sorgente
Ex-officio members:
- The President of the National Bioethics Committee
- The President of the National Committee for Biosafety, Biotechnology and Life Sciences
- The President of the National Institute of Health (ISS).
The meetings are attended by AIFA Director General, who ensures the coordination of the secretarial functions of the Centre.
The settlement meeting was held on Tuesday, June 1, 2021.
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Clinical Trial Agreement for the Drug (10/11/2022) [0.06 Mb] [DOCX] >
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Independent Clinical Trial Agreement for the Drugs (10/11/2022) [0.05 Mb] [DOCX] >
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Contract for conducting clinical investigation on a medical device not EC marked or EC marked but used outside the scope of its intended use (10/11/2022) [0.13 Mb] [DOC] >
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Agreement for conducting a clinical investigation aimed at further evaluating an EC marked medical device used within its intended use (10/11/2022) [0.06 Mb] [DOCX] >
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Declaration of interests (10/11/2022) [0.03 Mb] [DOCX] >
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Reimbursements and allowances for trial participants (10/11/2022) [0.03 Mb] [DOCX] >
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Compliance with member state applicable rules for the collection, storage and future use of human biological samples [0.05 Mb] [DOCX] >
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Information for the participation of patients in a clinical trial (20/05/2022) [0.08 Mb] [DOCX] >
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Parental consent form legal guardian (20/07/2020) [0.09 Mb] [DOCX] >
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Mature minor form (20/07/2020) [0.08 Mb] [DOCX] >
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Information minors (20/07/2020) [0.21 Mb] [DOCX] >
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Calendario riunioni Centro di coordinamento 2023 [0.47 Mb] [PDF] >
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Ordine del giorno del 18/05/2023 [0.59 Mb] [PDF] >
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Ordine del giorno del 04/05/2023 [0.59 Mb] [PDF] >
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Ordine del giorno del 06/04/2023 [0.59 Mb] [PDF] >
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Ordine del giorno del 02/03/2023 [0.69 Mb] [PDF] >
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Ordine del giorno del 09/02/2023 [0.69 Mb] [PDF] >
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Ordine del giorno del 12/01/2023 [0.6 Mb] [PDF] >
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Ordine del giorno del 15/12/2022 [0.6 Mb] [PDF] >
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Ordine del giorno del 10/11/2022 [0.6 Mb] [PDF] >
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Ordine del giorno del 13/10/2022 [0.64 Mb] [PDF] >
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Ordine del giorno del 08/09/2022 [0.08 Mb] [PDF] >
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Ordini del giorno del 21/07/2022 [0.53 Mb] [PDF] >
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Ordini del giorno dal 06/07/2021 al 09/06/2022 [5.09 Mb] [ZIP] >
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Ordini del giorno dal 14/09/2018 al 24/05/2021 [6.34 Mb] [ZIP] >