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 of 23 September 2024 provided for the reconstitution of the Coordination Centre.
Named Components:
- Carlo Maria Petrini (President)
- Roberto Poscia (Vice President)
- Alberto Giovanni Ambrosio
- Ilaria Bolcato
- Pietro Calamea
- Marco Callori
- Annalisa Capuano
- Fidelia Cascini
- Tommasina Iorno
- Francesco Leonetti
- Giovanni Nigro
- Roberta Pellegrini
- Maria Platter
- Luca Roberti
Legal components:
- 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 President of the Italian Medicines Agency participates in the meetings of the Coordination Center.
The Technical-Scientific Director of the Agency, or a person delegated by him, ensures the secretarial function of the same Center through the competent Technical Office.
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Clinical Trial Agreement for the Drug(s) (22/05/2024) [0.07 Mb] [DOCX] >
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Independent Clinical Trial Agreement for the Drugs (22/05/2024) [0.08 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 interest (21/04/2024) [0.04 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] >