AUSTRIA Law and Practice Contributed by: Sonja Hebenstreit, Michael Cepic and Maximilian Kröpfl, Herbst Kinsky Rechtsanwälte GmbH
2.3 Public Availability of the Conduct of a Clinical Trial For medicinal products, information on clinical trials initiated under the CTR as of 31 January 2022 (including the start and end dates of the tri- al, details of the sponsor, and trial results) is pub- licly available on the EU Clinical Trials website. Information on clinical trials initiated under the former system of Directive 2001/20/EC (before 31 January 2022) may still be accessed via the EU Clinical Trials Register. No publicly accessible register is currently provided at the EU or national level for clinical investigations and performance studies under the MDR and the IVDR. However, information on such trials will be accessible via the EUDAMED database as soon as the entire EUDAMED sys- tem has been declared fully functional. At the national level, the legislator did not exer- cise the option to provide for the maintenance of a (publicly accessible) register for non-interven- tional studies of medical devices via ordinance. 2.4 Restriction on Using Online Tools to Support Clinical Trials In Austria, it is not generally prohibited to con- duct the consent procedure remotely or to remotely supervise certain tasks/procedures carried out at home by a physician. Remote access to source data for the purpose of moni- toring is also permissible; however, this only applies to original electronic medical records and where a correspondingly validated record system is being used. In December 2022, the EU Decentralised Clinical Trial (DCT) project team published a recommen- dation paper on decentralised (remote) elements in clinical trials. The team comprises experts from the Clinical Trial Coordination Group, the
Clinical Trial Expert Group, European Medicines Agency (EMA) scientific committees, EMA work- ing parties, and EMA staff. This document also includes guidance concerning national provi- sions on the use of online tools in clinical stud- ies within the EU. As regards special measures due to COVID-19, see 11.2 Special Measures Relating to Clinical Trials . 2.5 Use of Data Resulting From Clinical Trials Clinical studies involve the processing of patients’ contact and health information, which qualify as personal data as defined by Article 4(1) of the General Data Protection Regulation (EU) 2016/679 (GDPR). To the extent that patients are identified or at least identifiable in data resulting from the clinical trial, these data sets must also be qualified as special categories of personal data (sensitive data). The processing of personal data in the context of a clinical trial is generally based on the patient’s consent pursuant to Article 6, paragraph 1(a) – in the case of sensitive data in conjunction with Article 9, paragraph 2(a) – of the GDPR. Accord- ingly, any disclosure of personal data to third parties must be covered by this consent. Furthermore, personal data can also be pro- cessed in the course of scientific research on the basis of the Austrian Research Organization Act ( Forschungsorganisationsgesetz , or FOG), pro- vided that the processing methods mentioned there, such as anonymisation or pseudonymisa- tion, are concerned (Article 2(2)(1) FOG).
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