The Central Emilia Wide Area Ethical Committee of the Emilia-Romagna Region (CE-AVEC), located at the IRCCS Azienda Ospedaliero - Universitaria di Bologna, Policlinico di S. Orsola, was established by regional resolutions n. 923 of 05/06/2023 and n.1028 of 19/06/2023 and operates in accordance with the D.M. of January 26, 2023 "Identification of forty territorial ethical committees" and the DM of January 30, 2023 "Definition of criteria for the composition and functioning of territorial ethics committees"

The CE-AVEC acts as the Territorial Ethics Committee (CET) for the evaluation of:

• clinical trials of Phase I, II, III and IV medicinal products for human use in respect of the aspects covered by Part II of the assessment report referred to in Article 7 of Regulation (EU) n. 536/2014, including the evaluation of aspects related to the study protocol, included in part I of the evaluation report referred to in art. 6 of Regulation (EU) No 536/2014 jointly with the competent authority,
• clinical investigations of medical devices,
• of pharmacological observational studies.

In addition, the CE-AVEC acts as a Local Ethics Committee (CEL) for the evaluation of any other type of study involving human beings usually submitted to the opinion of the Ethics Committees.

The local secretariat at the Rizzoli Orthopaedic Institute acts as the reference secretariat for clinical studies conducted at the Rizzoli Orthopaedic Institute.

• For submission of studies to the AVEC Ethics Committee, requests for evaluation of studies and amendments, other communications, documents shall be sent to the Clinical Trial Center (CTC) of the Rizzoli Institute, which will proceed in the verification and will forward them to the local secretary of the CE-AVEC.
• For communications and enquiries concerning the trials, please contact the Local IOR – CE AVEC Secretary, located by the Pharmacy, via G.C.Pupilli 1, 40136 Bologna Italy - e-mail segreteria.ce@ior.it.

For information on the check-lists of the documentation to be submitted, the centre-specific forms to be filled in, the possible financial charges and any other information regarding the CE-AVEC, please refer to the dedicated website (in Italian).