\tSupport from the very beginning \u2013 Kick-off meeting\u00a0<\/p>\n
A key part of the service is the Kick-off meeting. During this initial consultation, the team works together with researchers to assess the project’s starting point and discuss the key regulatory considerations.\u00a0<\/p>\n
For example, the meeting clarifies whether the external page Human Research Act (HRA)<\/a> applies, which risk category the project falls into, whether regulatory approval is required, and which documentation needs to be prepared. This gives researchers a clear roadmap for the next steps of their project.\u00a0<\/p>\n In addition, the team supports ETH researchers in establishing and maintaining a Quality Management System (QMS)<\/a>. It provides standardised processes, templates, and structures that support the consistent, transparent, and quality-assured conduct of human research projects.\u00a0<\/p>\n Specialised support for medical devices\u00a0<\/p>\n For projects involving medical devices<\/a>, the team offers additional specialized support. Our expert assists researchers in defining a clear intended use at an early stage, helping them establish the appropriate regulatory pathway from the outset.\u00a0<\/p>\n Dietmar Schaffarczyk, a member of the team and lecturer at the Department of Health Sciences and Technology, explains why this early support is so important:\u00a0<\/p>\n \u201cThe most critical phase in the development of a medical device is not the clinical study. It is the period before it\u2014when decisions are made about what the device is intended to do, which risks need to be managed, and what evidence will ultimately be accepted. At this early stage, the Team Consulting Human Research Act provides guidance, regulatory expertise, and additional development perspectives drawn from human research, as well as from the relevant regulations and standards. This often leads to insights that can easily be overlooked in a purely research-focused environment but later prove crucial for a project’s success, safety, and regulatory approval.\u201d\u00a0<\/p>\n The relevant regulatory frameworks in this context include the Ordinance on Clinical Trials of Medical Devices (ClinO-MD), the Medical Device Regulation (MDR), and the In Vitro Diagnostic Regulation (IVDR).\u00a0<\/p>\n REDCap for professional data management\u00a0<\/p>\n In addition to its advisory services, ETH Zurich provides its researchers with free access to a validated version of REDCap (Research Electronic Data Capture) for human research projects. REDCap is an internationally established platform for the structured collection and management of research and study data and is hosted in ETH Zurich’s secure Leonhard Med Trusted Research Environment<\/a>.\u00a0<\/p>\n REDCap enables researchers to create electronic questionnaires, centrally collect and manage data, and administer studies efficiently. Role-based access controls help protect sensitive information, while a comprehensive audit trail records all changes, ensuring full traceability. The platform also supports data export for statistical analysis and can be flexibly adapted to a wide range of study designs, making it suitable for both small-scale projects and large, complex studies.\u00a0<\/p>\n","protected":false},"excerpt":{"rendered":"Support from the very beginning \u2013 Kick-off meeting\u00a0 A key part of the service is the Kick-off meeting.…\n","protected":false},"author":2,"featured_media":100375,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":"","_share_on_mastodon":"0"},"categories":[6],"tags":[3411,3309,15399,51],"class_list":["post-100374","post","type-post","status-publish","format-standard","has-post-thumbnail","category-zurich","tag-administration-and-infrastructure","tag-ethics","tag-internal-news","tag-zurich"],"share_on_mastodon":{"url":"https:\/\/pubeurope.com\/@ch\/116889279733407443","error":""},"_links":{"self":[{"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/posts\/100374","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/comments?post=100374"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/posts\/100374\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/media\/100375"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/media?parent=100374"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/categories?post=100374"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/tags?post=100374"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}