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  • Hello All,   Welcome to all the new members of the CTD Community! Several of you have reached out to me with questions about our monthly conference calls.  Please find some useful information below. Meeting Schedule The CTD Community Call happens ...

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    EUDAMED Updates

    All, A new webpage with basic information related to EUDAMED Actor Registration module has been made available by EMA. This page includes various infographics and guidance documents with respect to Single Registration Number (SRN), actor registration ...

  • Hello All, The EMA asked me to share this information: We would like to make Sponsors aware there is an issue with the assignment of primary users of trials, as well as with the activation of results user roles in EudraCT. Our IT is working to fix ...

  • Hello All,  FYI: The EMA issued a draft guideline on registry-based studies on 24Sep2020 which is open for public consultation 31Dec2020 https://www.ema.europa.eu/en/human-regulatory/post-authorisation/patient-registries#draft-guideline-on-registry-based-studies:-open-for-public-consultation-(new)-section ...

  • Hello all, DIA is seeking nominations for the 2020 DIA Inspire Community Engagement Award! DIA Inspire Awards combine recognition of those who have provided outstanding contributions to advancing global health with volunteer service awards that honor ...

  • Hello Ashmita, I do not, but the EMA will be on the call and will be happy to answer questions! ------------------------------ Warm Regards, Francine Lane Vice President, Global Transparency TrialScope Jersey City NJ +1(646)229-4517 -------------- ...

  • Please join us for the CTD Community call on our monthly conference call on Tuesday, October 13 at 10am EST.     This month we have several updates from the EMA and CTGOV.  In addition, we’ll have an open discussion. Some topics to consider: ...

  • Dear All, Just a reminder that poster abstracts for the virtual Global Clinical Trial Disclosure & Data Transparency Conference on November 16 th – 18 th are due October 15 th ( https://www.diaglobal.org/abstract/meeting-details?productID=9289747&productcode=20119CFP ...

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    CTIS Audit

    Dear all, EMA announced October 5 th that the audit of the Clinical Trials Information System (CTIS) will commence in November 2020. The CTIS 'go-live' date is still planned for December 2021. Best regards, Bob ------------------------------ ...

  • Dear All, In addition to the expected update of October 01, 2020 in ClinicalTrials.gov PRS, the following updates have been posted on ClinicalTrials.gov public website: Frequently Asked Questions : The   Frequently Asked Questions   (FAQ) page ...

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