Evaluation request

Published 25/03/2020 - Edited 31/01/2025

Evaluation request

The CEN has exclusive competence for the evaluation of clinical trials on medicinal products, clinical investigations on medical devices and observational pharmacological studies conducted by Public Research Bodies (EPR) and other national public institutions.

Territorial ethics committees (CET) are in charge for the evaluation of studies conducted by research hospitals (IRCCS).

For the registration of clinical trials on medicinal products according to Regulation (EU) 536/2014, the CTIS portal is active. For these submissions, please contact the Scientific Secretariat of the National Ethics Committee (CEN) at segreteria.comitatoetico@iss.it

Pharmacological observational studies must be managed in accordance with AIFA directoral decision 425/2024 “Guideline for the classification and conduct of observational studies on medicines”.

They can be started only after receiving a favorable opinion from the competent Ethics Committee, valid for all the centres in which the study will be carried out (Decree of 30 November 2021, art. 2, paragraph 6) and after having fulfilled the requirements set out in the Observational Studies Register.

Amendment requests must be submitted to the Ethics Committee by e-mail to the following address: segreteria.comitatoetico@iss.it

AIFA directoral decision 425/2024 can also be taken as a reference for non-pharmacological observational studies, in view of the similar methodological approach applied.

For clinical investigations on medical devices, with and without CE marking, it is necessary to submit the documentation required by the regulations in force, i.e. Regulation (EU) 2017/745, which contains a specific reference to the technical standard UNI EN ISO 14155:2020 (“Clinical investigation of medical devices for human subjects - Good clinical practice”).

For further information regarding clinical investigations of medical devices, please refer to the Ministry of Health website.

Please note that any study involving the processing of personal data must be carried out in compliance with the provisions of the European Data Protection Regulation (Regulation (EU) 2016/679 - G.D.P.R.).

Only non-personal, or anonymous, data is released from the requirements of the Regulation.

So-called “pseudonymised” data are personal data insofar as it is possible to re-identify the subject.

The Data Controller, understood as “the natural or legal person, public authority, agency or other body which alone or jointly with others determines the purposes and means of the processing of personal data” (Art. 4. par. 1, no. 7 GDPR), carries out the assessment of compliance with the GDPR prior to submission of the project to the National Ethics Committee, assisted by the Data Protection Officer (DPO) of the Structure/Centre/Institution to which it belongs, who will issue a certificate of compliance.

The request for evaluation must be addressed to the CEN, by means of a letter signed by the person in charge of the study and co-signed by the director of their centre or department. The request and the documents required for the evaluation must be sent in electronic format to the CEN Secretariat: segreteria.comitatoetico@iss.it

The evaluation request must contain the following information

title of the research;

indication if it is a multicentre study;

name of the person in charge of the research with relevant affiliation;

promoter and funding body;

list of submitted attachments.

For all studies, essential documents to be attached are:

(All. A) - study protocol with number of version and date (e.g. dd/mm/yyyyy version);

(All. B) - summary sheet of the protocol;

(All. C) - list of centres involved and their local contact persons, if the study is multicentre;

(All. D) - participant information and informed consent forms with updated date (e.g. dd/mm/yyyyy version);

(All. E) - personal data processing information forms with updated date (e.g. version of dd/mm/yyyyy);

(All. F) - curriculum vitae of the Principal Investigator and any publications relevant to the proposed study;

(All. G) - evaluation by the DPO of the relevant structure.

EVALUATION REQUESTS WITH INCOMPLETE DOCUMENTATION WILL NOT BE TAKEN INTO CONSIDERATION

THE OPINION OF THE CEN MUST BE OBTAINED BEFORE THE START OF THE RESEARCH

Issuing and sending the opinion

The study, which is included in the agenda of the CEN meeting, is normally presented at the hearing by the Principal Investigator or his contact person.

For clinical trials with medicinal products, the issuing of the opinion will take place via the CTIS platform.

For other types of projects, following the plenary discussion and evaluation, the CEN issues the following types of opinion:

approval (with possible recommendations);

approval, subject to the request for modifications and/or integrations: the researcher is requested to send the modified documentation with verification of the changes made by the secretariat or, if necessary, by the CEN in a plenary session;

suspension with indication of changes or additions: it requires a new submission by the researcher of the amended documentation with the CEN review in a plenary session of changes made;