Swiss Clinical Trial Organisation

📌📋Les ordonnances d’exécution de la loi relative à la recherche sur l’être humain adaptées entrent en vigueur aujourd’hui⚕️ ✍️Le Conseil fédéral a approuvé les adaptations apportées aux ordonnances d’exécution de la loi relative à la recherche sur l’être humain et les a adoptées le 7 juin 2024. Les adaptations renforcent la protection des personnes qui participent à la recherche et améliorent, là où cela est possible, les conditions-cadres pour les chercheuses et chercheurs. Les ordonnances d’exécution de la loi relative à la recherche sur l’être humain adaptées entreront en vigueur le 1er novembre 2024, à l’exception des dispositions relatives à la transparence, qui prendront, elles, effet à partir du 1er mars 2025. La page suivante, qui sera mise à jour en permanence, renseigne sur la procédure pratique à appliquer pour soumettre une demande d’essai clinique de médicaments à Swissmedic avant et après l’entrée en vigueur des ordonnances d’exécution de la loi relative à la recherche sur l’être humain. 👩🏻⚕️ https://bit.ly/4hu01bC

☄️ 𝐒𝐞𝐦𝐢𝐧𝐚𝐫 𝐦𝐚𝐭𝐞𝐫𝐢𝐚𝐥𝐬 𝐟𝐫𝐨𝐦 𝐭𝐡𝐞 “𝐎𝐧𝐥𝐢𝐧𝐞 𝐬𝐞𝐦𝐢𝐧𝐚𝐫: 𝐇𝐑𝐀 𝐨𝐫𝐝𝐢𝐧𝐚𝐧𝐜𝐞𝐬 – 𝐰𝐡𝐚𝐭 𝐡𝐚𝐬 𝐜𝐡𝐚𝐧𝐠𝐞𝐝?” 𝐧𝐨𝐰 𝐚𝐯𝐚𝐢𝐥𝐚𝐛𝐥𝐞 𝐨𝐧 𝐭𝐡𝐞 𝐒𝐂𝐓𝐎 𝐏𝐥𝐚𝐭𝐟𝐨𝐫𝐦𝐬 𝐰𝐞𝐛𝐬𝐢𝐭𝐞 ☄️ Download now the slides and video now: https://lnkd.in/erqYwraB   The Q&A document will be uploaded soon.   👉 📩 𝐃𝐨𝐧’𝐭 𝐦𝐢𝐬𝐬 𝐨𝐮𝐭 𝐨𝐧 𝐟𝐮𝐭𝐮𝐫𝐞 𝐭𝐫𝐚𝐢𝐧𝐢𝐧𝐠 𝐨𝐩𝐩𝐨𝐫𝐭𝐮𝐧𝐢𝐭𝐢𝐞𝐬 𝐟𝐫𝐨𝐦 𝐭𝐡𝐞 𝐒𝐂𝐓𝐎 𝐚𝐧𝐝 𝐬𝐮𝐛𝐬𝐜𝐫𝐢𝐛𝐞 𝐭𝐨 𝐨𝐮𝐫 𝐧𝐞𝐰𝐬𝐥𝐞𝐭𝐭𝐞𝐫 𝐭𝐨𝐝𝐚𝐲: https://lnkd.in/eV-45NUX

How can we improve data sharing and get the data out of the silos? - We have a lot of knowledge on data sharing laws and processes, but it’s difficult to put them into practice - Increasing the quality of data capture at the source is the key to improve data interoperability - Patients can benefit from better care if we moved towards a culture of sharing data, while keeping data protection high - Data sharing would be easier if institutional, cantonal, and federal legal frameworks were harmonized. Very insightful panel discussion with Prof. Murielle Bochud (Unisanté), Prof. Jörg Goldhahn (ETH Zürich), Dr. Elke Mittendorf (Universitätsspital Zürich), Dr. Lukas Engelberger (Schweizerische Gesundheitsdirektorenkonferenz) #DataForHealth2024 #DataForHealth #PersonalizedHealth #HealthData Swiss Personalized Health Network (SPHN)  PHRT - Personalized Health and Related Technologies

❗ 𝐉𝐨𝐢𝐧 𝐮𝐬 𝐟𝐨𝐫 𝐨𝐮𝐫 𝐭𝐡𝐢𝐫𝐝 𝐥𝐮𝐧𝐜𝐡 𝐬𝐞𝐬𝐬𝐢𝐨𝐧 "𝐃𝐚𝐭𝐚 𝐬𝐡𝐚𝐫𝐢𝐧𝐠 𝐚𝐧𝐝 𝐨𝐩𝐞𝐧 𝐫𝐞𝐬𝐞𝐚𝐫𝐜𝐡 𝐝𝐚𝐭𝐚 - 𝐝𝐞𝐭𝐚𝐢𝐥𝐬 𝐟𝐨𝐫 𝐇𝐑𝐎 𝐩𝐫𝐨𝐣𝐞𝐜𝐭𝐬" 𝐨𝐧 𝟏𝟑 𝐍𝐨𝐯𝐞𝐦𝐛𝐞𝐫 𝟐𝟎𝟐𝟒 𝐟𝐫𝐨𝐦 𝟏𝟐:𝟎𝟎 𝐭𝐨 𝟏𝟑:𝟎𝟎.❗ This session is being organised in collaboration with the Swiss Personalized Health Network (SPHN) and will highlight common practices, possibilities, and “must-knows” related to data storage and data sharing. ⚠️ Register now for this insightful session: https://lnkd.in/ejw72VZs #SCTO #HRO #session

🚀 𝐑𝐞𝐯𝐢𝐞𝐰: 𝐎𝐧𝐥𝐢𝐧𝐞 𝐬𝐞𝐦𝐢𝐧𝐚𝐫 𝐨𝐧 𝐇𝐑𝐀 𝐨𝐫𝐝𝐢𝐧𝐚𝐧𝐜𝐞𝐬 - 𝐖𝐡𝐚𝐭 𝐡𝐚𝐬 𝐜𝐡𝐚𝐧𝐠𝐞𝐝? 🚀 With over 𝟒𝟓𝟎 𝐩𝐚𝐫𝐭𝐢𝐜𝐢𝐩𝐚𝐧𝐭𝐬, the online seminar on the revised Human Research Act (HRA) ordinances, held on 28 October and organised by the Regulatory Affairs Platform and the Education Platform, garnered significant interest from the public. 💡   After the insightful presentations, participants asked many questions, so there was not enough time to answer all of them. Responses to these questions will be compiled in a Q&A document and uploaded soon to the SCTO Platforms website, along with the presentation slides and other useful links: https://lnkd.in/erqYwraB   👉 📩 𝐃𝐨𝐧’𝐭 𝐦𝐢𝐬𝐬 𝐨𝐮𝐭 𝐨𝐧 𝐟𝐮𝐭𝐮𝐫𝐞 𝐭𝐫𝐚𝐢𝐧𝐢𝐧𝐠 𝐨𝐩𝐩𝐨𝐫𝐭𝐮𝐧𝐢𝐭𝐢𝐞𝐬 𝐟𝐫𝐨𝐦 𝐭𝐡𝐞 𝐒𝐂𝐓𝐎 𝐚𝐧𝐝 𝐬𝐮𝐛𝐬𝐜𝐫𝐢𝐛𝐞 𝐭𝐨 𝐨𝐮𝐫 𝐧𝐞𝐰𝐬𝐥𝐞𝐭𝐭𝐞𝐫 𝐭𝐨𝐝𝐚𝐲: https://lnkd.in/eV-45NUX   https://lnkd.in/erqYwraB

We're excited to announce the agenda for our 4th annual CTU Day is now live! 📣 This event is for staff from the CTUs of our national networks. We look forward to sharing updates from across ECRIN as well as supporting the advancement of academic clinical research through some timely topics. You can register today: https://lnkd.in/e9FTAdXT We're looking forward to seeing you online on December 13. 💻 #CTUDay2024 #ECRINCommunity #ClinicalTrials CZECRIN, Infrastructure F-CRIN, GreCRIN _ECRIN, HECRIN, Health Research Board (HRB), HRB National Clinical Trials Office (NCTO), ItaCRIN, NorCRIN, PCTN (Agencja Badań Medycznych), PtCRIN Portuguese Clinical Research Infrastructure Network, SLOVACRIN, Spanish Clinical Research Network (SCReN), Swiss Clinical Trial Organisation

🌟 𝐄𝐱𝐜𝐢𝐭𝐢𝐧𝐠 𝐍𝐞𝐰𝐬 𝐟𝐫𝐨𝐦 𝐄𝐂𝐑𝐈𝐍! 🌟   ECRIN (European Clinical Research Infrastructure Network) is thrilled to announce the launch of 𝐑𝐄𝐃 (𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐚𝐧𝐝 𝐄𝐭𝐡𝐢𝐜𝐚𝐥 𝐃𝐚𝐭𝐚𝐛𝐚𝐬𝐞) - a newly updated tool designed to support the European clinical research community with essential resources and guidance. 👏   RED provides in depth coverage across European countries, ensuring that you have access to detailed regulatory and ethical submission requirements tailored to a variety of key clinical study types.    ▶️ Explore the RED tool here: https://red.ecrin.org/en   ⚠️ Stay tuned: The Swiss-specific information will be available soon, and we’ll keep you updated as we roll it out. #ECRIN #RED

📅 𝐃𝐨𝐧'𝐭 𝐦𝐢𝐬𝐬 𝐭𝐡𝐞 "𝐨𝐧𝐥𝐢𝐧𝐞 𝐬𝐞𝐦𝐢𝐧𝐚𝐫: 𝐇𝐑𝐀 𝐨𝐫𝐝𝐢𝐧𝐚𝐧𝐜𝐞𝐬 - 𝐰𝐡𝐚𝐭 𝐡𝐚𝐬 𝐜𝐡𝐚𝐧𝐠𝐞𝐝?" 𝐭𝐡𝐢𝐬 𝐌𝐨𝐧𝐝𝐚𝐲, 𝟐𝟖 𝐎𝐜𝐭𝐨𝐛𝐞𝐫 𝟐𝟎𝟐𝟒, 𝟏𝟏.𝟎𝟎-𝟏𝟐.𝟎𝟎.❗ Join us for an insightful one-hour session on the latest changes to the Human Research Act (HRA) ordinances, organised by the Regulatory Affairs Platform and the Education Platform of the SCTO. The amendments aim to improve regulations by addressing technological and societal developments, aligning with international standards. 👉 Download the Zoom link here and participate in this free online training: https://lnkd.in/erqYwraB #SCTO #SCTOPlatforms #HRA #ordinances

Das Humanforschungsgesetz (HFG) feiert dieses Jahr sein 10-jähriges Bestehen. Es hat erstmals einen einheitlichen Rahmen für die Forschung am Menschen geschaffen, was die Transparenz und Sicherheit in der Humanforschung bedeutend verbessert hat. Anlässlich dieses Jubiläums organisiert das BAG das Symposium «10 Jahre Humanforschungsgesetz: Vergangenheit, Gegenwart, Zukunft» am Freitag, 22. November 2024 im Kursaal in Bern. Neben weiteren Referierenden wird Katrin Simioni am Anlass einen Blick in die Zukunft der klinischen Forschung am Menschen werfen. Das gesamte Programm finden Sie hier 👉 https://lnkd.in/dFd-CVMr Anmeldungen ✏️ https://lnkd.in/dCecif4E La loi relative à la recherche sur l’être humain (LRH) fête ses 10 ans ! Elle a été la première à créer un cadre uniforme pour la recherche dans ce domaine, améliorant ainsi considérablement la transparence et la sécurité en la matière. Pour marquer le coup, l’OFSP organise le symposium « Dix ans de loi relative à la recherche sur l’être humain : passé, présent, avenir », qui aura lieu le vendredi 22 novembre 2024 au Kursaal de Berne. Parmi d’autres intervenants, Katrin Simioni jettera un regard sur l’avenir de la recherche clinique. Vous trouverez le programme complet ici 👉 https://lnkd.in/dD_xmtQG Inscriptions ✏️ https://lnkd.in/dMvh8bHe Quest’anno la legge sulla ricerca umana (LRUm) compie 10 anni. Con la sua entrata in vigore, è stato creato per la prima volta un quadro uniforme che ha consentito di migliorare significativamente la trasparenza e la sicurezza nel settore della ricerca sull’essere umano. Per festeggiare questo anniversario, l’UFSP organizza il simposio «La legge sulla ricerca umana compie 10 anni: passato, presente, futuro», che si terrà venerdì 22 novembre 2024 al Kursaal di Berna. Tra i vari relatori che parteciperanno all’evento, Katrin Simioni getterà uno sguardo al futuro della ricerca umana. Il programma è disponibile qui 👉 https://lnkd.in/df5a5m9x Iscrizione ✏️ https://lnkd.in/ddwXPsFT

🎉 Congratulations to Alan Haynes on receiving a SCTO statistical programming grant for the randolist/ralloc project! 🎉 At the recent annual meeting of the SCTO Statistical Platform, 23 statisticians from eight institutions – including CTC Zürich, SAKK, DKF Basel, DCR Bern, CRC Lausanne, Dept. Biostatistics UZH, CTU Lugano and CTU St. Gallen – met up and discussed new updates, projects and awarded grants to support the development of statistical code. At this meeting, Alan Haynes and the DCR Statistics team received a grant for their work creating a randomization list generation tool. #DCR #SCTO #Statistics #ClinicalResearch