NETHERLANDS Law and Practice Contributed by: Hamza Zourakhti and Barbara van der Ven, Brande & Verheij LLP
2.3 Public Availability of the Conduct of a Clinical Trial Pharmaceuticals An application for a clinical trial must be registered in CTIS. Regardless of the outcome of a clinical trial, the sponsor must submit a summary of the results of the clinical trial within one year after the end of the clinical trial in the member states concerned. This must be accompanied by a summary that is understandable to a layperson. For clinical trials initiated prior to 31 January 2022, access to information is provided via the EU Clinical Trials Register. Medical Devices At the moment, there is no publicly available database that provides insight into clinical investigations or per- formances studies under the MDR and IVDR. How- ever, once the Clinical Investigations and Performance Studies module of EUDAMED becomes operational, the registration becomes mandatory. This mandatory registration requirement shall take effect six months after publication of the notice confirming the function- ality of the module in the Official Journal of the EU. 2.4 Use of Online Tools to Support Clinical Trials In addition to the General Data Protection Regulation (EU) 2016/679 (GDPR) and related laws and regula- tions (see 2.6 Personal or Sensitive Data ), the WMO is also relevant with regard to the use of online tools in clinical research. Recruitment materials (including online tools) and digital monitoring methods must be submitted to and approved by a MREC or the CCMO. Online tools must not mislead participants and must ensure sufficient transparency. 2.5 Use of Data From Clinical Trials Under Dutch law, data resulting from clinical trials qualifies as personal data within the meaning of the GDPR insofar as the data relates to an identified or identifiable research subject. As clinical research involves information about a person’s health, physi- cal or mental condition, such data will, in principle, constitute special categories of personal data (sensi- tive data) under the GDPR. Coded or pseudonymised data is, in principle, still considered personal data as re-identification of individuals is usually reasonably possible.
All applications must be submitted via the Research Portal of the CCMO, until the relevant modules of EUDAMED become fully operational. The application procedure depends on whether the application con- cerns clinical investigations in the context of conform- ity purposes (Articles 62 and 74 (2) MDR), other clinical investigations (Article 82 MDR) or post-market clinical follow-up investigations (Article 74 (1) MDR). • Conformity: The research file will first be validated by CCMO. Indeed, CCMO will review whether the clinical investigation falls within the scope of the MDR and whether the research file is com- plete (this check is merely administrative; CCMO will not perform a substantive assessment on the completeness). In case of a negative validation, the sponsor can file an objection to CCMO. After a positive decision on the validation, CCMO will transfer the applicant’s file to the review committee (either an accredited MREC or CCMO) for assess- ment. • Other Investigations and Post-Market Follow-Up: For other investigations or post-market follow-up investigations, the applicant can submit the file via the Research Portal, after which the file is directly forwarded to the review committee for assessment. The following deadlines apply: • For the validation phase, the deadline is a maxi- mum of ten (+ five) days for the initial review of the scope and completeness of the dossier. If the dossier is complete, the research file is forwarded to the review committee for assessment. Depend- ing on the class of medical devices, specific review committees are accredited. • For the assessment phase, the deadlines are (i) a maximum of 45 calendar days (+ 20 in case of expert consultations) for assessments regard- ing class IIa invasive, Class IIb invasive, Class III devices; and (ii) a maximum of 2 x 56 calendar days regarding Class I, Class IIa non-invasive and Class IIb non-invasive devices. The accredited MREC or CCMO can call a clock stop to request further information.
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