Medfiles’ Post

CTIS: only 6 months to go! 🗓️ 📄 𝗦𝗽𝗼𝗻𝘀𝗼𝗿𝘀, 𝗵𝗮𝘃𝗲 𝘆𝗼𝘂 𝘁𝗿𝗮𝗻𝘀𝗶𝘁𝗶𝗼𝗻𝗲𝗱 𝘁𝗼 𝘁𝗵𝗲 𝗻𝗲𝘄 𝗖𝗧𝗜𝗦 (𝗖𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗧𝗿𝗶𝗮𝗹𝘀 𝗜𝗻𝗳𝗼𝗿𝗺𝗮𝘁𝗶𝗼𝗻 𝗦𝘆𝘀𝘁𝗲𝗺) 𝘆𝗲𝘁? Since January 31, 2022, in accordance with EU’s CTR No. 536/20141, CTIS has been in use for all initial clinical trial applications in the European Union (EU). It is now the single entry-point for sponsors and regulators to submit and assess their clinical trial data. 𝗕𝘆 𝗝𝗮𝗻𝘂𝗮𝗿𝘆 𝟯𝟭, 𝟮𝟬𝟮𝟱, 𝗮𝗹𝗹 𝘁𝗿𝗶𝗮𝗹𝘀 𝘄𝗶𝗹𝗹 𝗯𝗲 𝗴𝗼𝘃𝗲𝗿𝗻𝗲𝗱 𝗯𝘆 𝘁𝗵𝗲 𝗻𝗲𝘄 𝗖𝗧𝗥, including ongoing trials approved under the CTD. Your study will stop if it is not transitioned. 𝗛𝗼𝘄𝗲𝘃𝗲𝗿, 𝘄𝗲 𝗿𝗲𝗰𝗼𝗺𝗺𝗲𝗻𝗱 𝘆𝗼𝘂 𝗸𝗲𝗲𝗽 𝗶𝗻 𝗺𝗶𝗻𝗱 𝘁𝗵𝗶𝘀 𝗲𝗮𝗿𝗹𝗶𝗲𝗿 𝗱𝗮𝘁𝗲: 𝗢𝗰𝘁𝗼𝗯𝗲𝗿 𝟭𝟲, 𝟮𝟬𝟮𝟰, 𝗮𝘀 𝘁𝗵𝗲 𝗳𝗶𝗻𝗮𝗹 𝗱𝗮𝘁𝗲 𝗳𝗼𝗿 𝘀𝘂𝗯𝗺𝗶𝘁𝘁𝗶𝗻𝗴 𝗮𝗽𝗽𝗹𝗶𝗰𝗮𝘁𝗶𝗼𝗻𝘀 𝘁𝗼 𝗴𝘂𝗮𝗿𝗮𝗻𝘁𝗲𝗲 𝘁𝗶𝗺𝗲𝗹𝘆 𝗽𝗿𝗼𝗰𝗲𝘀𝘀𝗶𝗻𝗴 𝗮𝗻𝗱 𝗳𝗶𝗻𝗮𝗹𝗶𝘇𝗮𝘁𝗶𝗼𝗻 𝗼𝗳 𝘁𝗵𝗲 𝘁𝗿𝗮𝗻𝘀𝗶𝘁𝗶𝗼𝗻 𝗽𝗿𝗼𝗰𝗲𝘀𝘀. Why? Because after that date, an expedited procedure may not be available. Do you need help with making the transition to CTR your priority in 2024? ExperTrials’s team of experts is here for you. ➡️ DM us for more information! #ClinicalTrialsInformationSystem #ClinicalTrialsRegulation #regulatorycompliance

The countdown to transition your clinical trials from EudraCT to EU CTIS is fast approaching. ARE YOU READY? All ongoing clinical trials present in the EU must be transitioned from EudraCT to CTIS by January 30, 2025. If you have not started the process already, please strongly considering jumping sooner vs later. The procedure to authorize the transition can take up to three months; therefore, it is important to begin transition activities now. Certara is prepared to assist in the smooth transition of your trails and available to discuss your next steps! #certara #clinicaltrials #eudraCT #EUCTIS

The countdown to transition your clinical trials from EudraCT to EU CTIS is fast approaching. ARE YOU READY? All ongoing clinical trials present in the EU must be transitioned from EudraCT to CTIS by January 30, 2025. If you have not started the process already, please strongly considering jumping sooner vs later. The procedure to authorize the transition can take up to three months; therefore, it is important to begin transition activities now. #certara #clinicaltrials #eudraCT #EUCTIS

Are you unsure about how to transition your studies from EudraCT to CTIS? Certara's team of dedicated and experienced disclosure professionals can help!

📣 Exciting CTIS News Alert! 📣 Back in October 2023, EMA's adoption of Revised CTIS Transparency Rules marked a pivotal moment in the evolution of clinical trial information dissemination. Since then, we've navigated through interim solutions, including uploading blank documents, to adhere to these rules until the anticipated launch of a new CTIS version in Q2/2024. Now, as EMA has officially announced yesterday the launch date of 18th June 2024, we're on the verge of experiencing substantial enhancements in transparency within the EU Clinical Trials Information System (CTIS). This milestone brings us closer to a more streamlined submission process, eliminating the need for workarounds and blank document uploads, along with the final removal of the deferral mechanism. As someone deeply involved in this field, I'm personally looking forward to these changes and am curious to see how the user experience will evolve within CTIS. Stay tuned for further details from EMA as they unveil more about the CTIS upgrade.🌟 #RegulatoryRocks #CTISrocks #CTIS #CTR #ClinicalTrials #SSU #regulatory #regaffairs #RegulatoryAffairs #StudyStartUp #CTDtoCTR

🌟𝗖𝗧𝗜𝗦 𝗦𝗲𝗿𝗶𝗲𝘀 𝗼𝗻 𝗟𝗶𝗻𝗸𝗲𝗱𝗜𝗻 (𝗰𝗼𝗻𝘁'𝗱): 𝗡𝗮𝘃𝗶𝗴𝗮𝘁𝗶𝗻𝗴 𝗖𝗧𝗜𝗦 - 𝗢𝗻𝗴𝗼𝗶𝗻𝗴 𝗧𝗿𝗶𝗮𝗹 𝗠𝗮𝗻𝗮𝗴𝗲𝗺𝗲𝗻𝘁 𝗮𝗻𝗱 𝗖𝗼𝗺𝗺𝗼𝗻 𝗖𝗵𝗮𝗹𝗹𝗲𝗻𝗴𝗲𝘀 𝗶𝗻 𝗖𝗧𝗜𝗦 In my previous post, I covered how to get started with the Clinical Trials Information System (CTIS). Today, I’ll discuss ongoing trial management and address common challenges you might face. 𝗢𝗻𝗴𝗼𝗶𝗻𝗴 𝗧𝗿𝗶𝗮𝗹 𝗠𝗮𝗻𝗮𝗴𝗲𝗺𝗲𝗻𝘁 Regularly checking the CTIS dashboard is essential for updates and required actions. Monitoring the progress of submissions and responding to regulatory queries promptly ensures smooth trial management. With the very tight timelines to respond to RFIs (Requests for Information), this step is crucial. Companies should have a plan in place for when team members should check CTIS for any incoming messages or updates, as the system does not provide push emails to inform you of changes. 𝗘𝗻𝗰𝗼𝘂𝗿𝗮𝗴𝗲 𝗖𝗼𝗹𝗹𝗮𝗯𝗼𝗿𝗮𝘁𝗶𝗼𝗻 Maintaining open communication within your team is crucial. It helps streamline the workflow and address issues promptly, enhancing overall efficiency and compliance. 𝗖𝗼𝗺𝗺𝗼𝗻 𝗖𝗵𝗮𝗹𝗹𝗲𝗻𝗴𝗲𝘀 𝗮𝗻𝗱 𝗦𝗼𝗹𝘂𝘁𝗶𝗼𝗻𝘀 𝗡𝗮𝘃𝗶𝗴𝗮𝘁𝗶𝗼𝗻𝗮𝗹 𝗗𝗶𝗳𝗳𝗶𝗰𝘂𝗹𝘁𝗶𝗲𝘀: Spend time exploring the system and refer to EMA’s detailed guidance documents. Practicing in the sandbox environment is highly beneficial. 𝗗𝗼𝗰𝘂𝗺𝗲𝗻𝘁 𝗠𝗮𝗻𝗮𝗴𝗲𝗺𝗲𝗻𝘁: Keep a checklist of required documents to ensure all submissions are complete and compliant. 𝗧𝗲𝗰𝗵𝗻𝗶𝗰𝗮𝗹 𝗜𝘀𝘀𝘂𝗲𝘀: Regularly check your emails for system upgrades and outages. EMA usually provides information on these via email. For persistent issues, contact the CTIS support team. By addressing these common challenges and implementing these solutions, you can manage your trials more effectively within CTIS. In our next post, we'll share best practices for submitting clinical trials in CTIS. 📆 𝗡𝗲𝗲𝗱 𝗲𝘅𝗽𝗲𝗿𝘁 𝗴𝘂𝗶𝗱𝗮𝗻𝗰𝗲 𝗼𝗻 𝗻𝗮𝘃𝗶𝗴𝗮𝘁𝗶𝗻𝗴 𝗖𝗧𝗜𝗦 𝗼𝗿 𝘁𝗿𝗮𝗻𝘀𝗶𝘁𝗶𝗼𝗻𝗶𝗻𝗴 𝗮 𝘁𝗿𝗶𝗮𝗹? 𝗦𝗰𝗵𝗲𝗱𝘂𝗹𝗲 𝗮 𝘀𝗹𝗼𝘁 𝗼𝗻 𝗺𝘆 𝗖𝗮𝗹𝗲𝗻𝗱𝗹𝘆. #RegulatoryRocks #CTISrocks #ClinicalTrials #CTIS #ClinicalResearch #RegulatoryAffairs #EUCTR #CTISsolutions

FDA Draft guidance for industry on data monitoring in clinical trials. 😎 The draft guidance would replace the "Establishment and Operation of Clinical Trial Data Monitoring Committees,” issued in March 2006. Please submit comments by April 15, 2024. #clinicaltrials #fda #datamonitoring

Essential documents in clinical trials are critical for ensuring compliance, maintaining data integrity, and safeguarding the rights and well-being of study participants throughout the research process. Our upcoming module will tell you everything you need to know about essential documents and how they should be filed in the TMF and ISF! #clinicaltrials #clinicalreseach #essentialdocuments #protocol #TMF #eTMF #GCP #goodclinicalpractice www.clincademy.com

📌 FREE #WEBINAR | Clinical Trials transition to CTR/CTIS ⏰ LAST HOURS TO REGISTER! 🔜 May 16, 2024 🕒3:00- 3:30 p.m. CET 💻 Virtual 🔗 Do not miss it!! You can still register and secure your spot here: https://bit.ly/4aztOLV 📧 For further information you can contact us at: info@asphalion.com https://bit.ly/3JpRqGN #FreeWebinar #Webinar #CTIS #CTR #ClinicalTrials #EU #Timelines #Procedures #Application #Regulatory #MeetTheExpert #RA #RegulatoryAffairs #MeetTheExpert #WeAreAsphalion #WeCare #KnowledgeFromExperience

𝗖𝗧𝗜𝗦: 𝘁𝗵𝗲 𝘁𝗿𝗮𝗻𝘀𝗶𝘁𝗶𝗼𝗻 𝗽𝗿𝗼𝗰𝗲𝘀𝘀 𝗶𝘀 𝗰𝗼𝗺𝗶𝗻𝗴 𝘁𝗼 𝗮𝗻 𝗲𝗻𝗱 🔔   Sponsors, have you transitioned to the new CTIS (Clinical Trials Information System) yet? The CTIS serves as a single entry point for clinical trial information in the EU and the European Economic Area (EEA). In less than 4 months (i.e., January 31, 2025) all clinical trials will be governed by the new CTR (Clinical Trial Regulation) and CTIS, including ongoing trials approved under the CTD. Your study will stop if it is not transitioned.   📆 𝗢𝗰𝘁𝗼𝗯𝗲𝗿 𝟭𝟲, 𝟮𝟬𝟮𝟰, 𝗶𝘀 𝘁𝗵𝗲 𝗳𝗶𝗻𝗮𝗹 𝗱𝗮𝘁𝗲 𝗳𝗼𝗿 𝘀𝘂𝗯𝗺𝗶𝘁𝘁𝗶𝗻𝗴 𝗮𝗽𝗽𝗹𝗶𝗰𝗮𝘁𝗶𝗼𝗻𝘀 𝘁𝗼 𝗴𝘂𝗮𝗿𝗮𝗻𝘁𝗲𝗲 𝘁𝗶𝗺𝗲𝗹𝘆 𝗽𝗿𝗼𝗰𝗲𝘀𝘀𝗶𝗻𝗴 𝗮𝗻𝗱 𝗳𝗶𝗻𝗮𝗹𝗶𝘇𝗮𝘁𝗶𝗼𝗻 𝗼𝗳 𝘁𝗵𝗲 𝘁𝗿𝗮𝗻𝘀𝗶𝘁𝗶𝗼𝗻 𝗽𝗿𝗼𝗰𝗲𝘀𝘀. The authorization procedure can take up to three months, so action is key.   ➡️ Do you need help with transitioning your trial? ExperTrials’s team is here to help. 📥 DM us for more information!   #ClinicalTrialsInformationSystem #ClinicalTrialsRegulation #regulatorycompliance