Clinical Trial Disclosure Community

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  • Monthly CTD Community Call: 11 Feb 2025

    Hi all,

    Julie and I are excited to welcome you all as new Co-chairs of CTD Community to our first community call in this role. The agenda is uploaded to CTD community library. Please feel free to review the agenda and if you have any questions or topics that you would like the group's or regulators' opinion on, please send those directly to Julie (julie@holtzopleconsulting.com) and me (sanjay@xogene.com). We will be sure to include those in the agenda.  

    Please see below for the details to join the meeting:

    Time: Feb 11, 2025 10:00 AM Eastern Time (US and Canada)

    Every month on the Second Tue.

    Join Zoom Meeting

    Meeting ID: 944 4832 8818

    Passcode: 224003

    One tap mobile

    +16468769923,,94448328818#,,,,*224003# US (New York)

    +16469313860,,94448328818#,,,,*224003# US

    Find your local number: diaglobal.zoom.us/u/aXvU5Mz3P

    We look forward to seeing you there!

    Thank you,

    Sanjay

  • DIA CTD Community - Join us on Tuesday, January 14th for our first CTD Community call of the year!

    Happy New Year! As we begin 2025, we hope this message finds you well. This promises to be an eventful year with significant developments in clinical trial transparency and disclosure across the globe.

    Join us for the January DIA CTD Community meeting where we will mark an important milestone in our community's journey. We are pleased to announce new leadership for our community, as we welcome our incoming chairs who will help guide our initiatives and discussions throughout 2025 and beyond. This transition represents an opportunity to bring fresh perspectives while building on our community's strong foundation of knowledge sharing and collaboration.

    As usual, we will have our regular updates from the ClinicalTrials.gov and EMA teams.

    Following the updates, we will continue our discussion on several important topics related to clinical trial disclosure and transparency, including:

    ·      The process for requesting trials on EudraCT for CTIS transition studies to facilitate structured results reporting

    ·      Industry practices regarding ClinicalTrials.gov release receipts in eTMF systems - exploring how companies manage these documents, from initial registration to subsequent updates

    ·      A call for expertise to help summarize and present the new Swiss regulatory requirements to our community in the coming year

    ·      Clarification on timing of summary results and layperson summary submission in CTIS:

    o   Context of the removed deferral option for documents at CTA submission

    o   Discussion of public disclosure timing when interim analyses lead to trial continuation or early termination

    o   Impact on market dynamics and need for clear guidance on CTIS handling of these scenarios

    This meeting is an opportunity to stay informed about the latest developments in clinical trial disclosure, share experiences with peers, and engage in discussions on these critical issues. We hope to see you there!

    Join Zoom Meeting

    https://diaglobal.zoom.us/j/94448328818?pwd=NnI1UFQrSWJLOTU4RzFIRlRCbnZYZz09

     

    Meeting ID: 944 4832 8818

    Passcode: 224003

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