LIFE SCIENCES | National FAQs on Clinical Trials updated

The FAQs issued by the National Coordination Centre of Ethics Committees (CCNCE), as updated on 28 January 2026, provide important interpretative clarifications and operational guidance in the field of clinical trials. Among the key issues addressed is post-trial therapeutic continuity, which –while not expressly mandated by a specific statutory provision – is grounded in the principles of Good Clinical Practice (GCP) and, in particular, in the Declaration of Helsinki. In this context, it is required that, prior to the commencement of the study, appropriate post-trial measures be envisaged for participants who continue to require an intervention deemed beneficial and reasonably safe. Such measures must be adequately described in the patient information sheet and informed consent form, and the Ethics Committee may request further clarifications from the Sponsor.

The FAQs also reaffirm the principle of independence of Ethics Committees, clarifying that a Sponsor who is a member of an Ethics Committee may not submit a study to the same Committee.

With regard to participants’ rights, the inclusion of clauses providing for the communication of unexpected findings is considered admissible, in line with the principles set out in the Declaration of Helsinki.

Further clarifications concern clinical trials submitted through the Clinical Trials Information System (CTIS): the approved patient information sheets and informed consent forms have nationwide validity and may not be modified at local level. Any additions—including those relating to personal data protection under the GDPR—must be submitted by the Sponsor as a formal modification.

Additional guidance is provided on the processing of personal data, including the obligation to submit a declaration of compliance with EU data protection legislation and to provide an information notice separate from the consent to participate in the trial. The Data Protection Impact Assessment (DPIA), however, remains the responsibility of the data controller.

Finally, in the field of medical devices, the FAQs clarify the requirements for the suitability of facilities—including private ones—and address issues relating to conflicts of interest.

Newsletter n. 116 – March 2026