Clinical Trial Disclosure Community

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  • DIA CTD Community - Join us on Tuesday, May 14th for our monthly conference call

    ALERT:  Log in information for the calls has been updated and a password is required!

    Join us for an informative and engaging May DIA CTD Community meeting! We are excited to have Niki Matskou from the DIA join us to get YOUR valuable feedback on a planned EU Workshop. As always, we will also have our regular updates from the ClinicalTrials.gov team and the EMA.

    Following the updates, we will open the floor for discussion on several critical topics related to clinical trial disclosure and transparency, including:

    • ·       Submission of annual progress reports via CTIS in Bulgaria, which are not required under the EU Clinical Trials Regulation
    • ·       Clarification on patient-facing documents and whether those not linked to endpoints need to be submitted
    • ·       Intended audience and potential triggers for public disclosure of MAA dossiers based on the "HMA/EMA guidance document on the identification of personal data and commercially confidential information within the structure of the marketing authorisation application (MAA) dossier"
    • ·       Interpretation of paragraph 8 of the Clinical Trials Regulation regarding intermediate data analysis and the definition of 'available results'

    ·       Don't miss this opportunity to provide feedback, gain valuable insights, and engage in discussions on these important issues. We look forward to seeing you at the meeting!

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