SPAIN Law and Practice Contributed by: Lluís Alcover, Eduard Rodellar, Laia Rull and Pablo Mansilla, Faus Moliner
The sponsor may select any CEIm within Spain to review the study and issue a favourable opin- ion. With respect to the CTA, there is no stand- ardised template for all Spanish sites. In prac- tice, each hospital/region usually has its own template. The sponsor may sign the CTA before obtaining the required authorisations (Article 17 of Royal Decree 1090/2015). In such cases, the CTA will become effective once both AEMPS and CEIm approvals are in place. Medical Devices Two different situations can be distinguished for clinical investigations involving medical devices: • clinical investigations involving medical devic- es without European Conformity ( Conformité Européenne CE) for conformity assess- ment, as well as those with CE marking used outside the scope of their intended purpose, require a favourable CEIm opinion, AEMPS approval and a written agreement between the sponsor and the sites; and • clinical investigations involving medical devices that have CE marking and are used in accordance with their instructions for use, and within the approved intended purpose when the CE marking was issued, require a favourable CEIm opinion and a written agree- ment between the sponsor and the sites – AEMPS approval is exempted. In the first situation, the sponsor must submit the documentation described in Chapter II of Annex 15 of Regulation (EU) No 2017/745. The AEMPS shall evaluate the documentation submitted and decide to either authorise or reject the clinical investigation. Additionally, if patients will undergo procedures beyond those applied under normal conditions of use, and these procedures are invasive or
burdensome, the sponsor shall notify this to the AEMPS through the database for clinical inves- tigations involving CE-marked medical devices (NEOPS). 2.3 Public Availability of the Conduct of a Clinical Trial The Spanish Registry of Clinical Studies ( Regis- tro Español de Estudios Clínicos REec) is a pub- lic database containing information on all clinical trials with medicinal products authorised by the AEMPS in Spain. It can be accessed through the AEMPS website. The sponsor must publish the results of the clini- cal trial, whether positive or negative, preferably in scientific journals before disclosure to the general public, as well as in the REec. For medical devices, there is currently no pub- licly available database specific for Spain. 2.4 Restriction on Using Online Tools to Support Clinical Trials The decentralisation of clinical trials (including the use of online tools for monitoring purposes) began with the COVID-19 pandemic, when the AEMPS amended its document of instructions to introduce exceptional measures regarding: • patient visits for ongoing clinical trials during the pandemic; • access to trial medicinal products; • the transfer of patients between sites; and • the procedure for obtaining patients’ informed consent. In view of the positive experience acquired, it has been considered convenient to facilitate the use of these decentralised aspects in clinical tri- als beyond the COVID-19 pandemic period. In November 2024, the AEMPS published a guide
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