Clinical Trial Disclosure

Community Chair

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Francine Lane

Vice President, Global Transparency, TrialScope

Latest Discussion Posts

  • 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 ...

  • Dear all,  The European Court of Justice announced 22 January 2020 that it has ruled that the European Medicines Agency (EMA) acted lawfully when it released certain toxicology reports and a clinical study report from two sponsors that wanted to keep ...

  • Hi Matthias, Thank you very much for sharing this interesting article. With best regards, Magda ------------------------------ Magdalena Lewandowska Events Manager DIA Europe, Middle East & Africa Basel +41(61)2255165 --------------------------- ...

  • Hello All! Happy New Year! I was very late in posting the December CTD Community call minutes and recording .  They are posted in Clinical Trial Disclosure (CTD) library folder. A special thanks to Nicole Hinton for taking those notes! Additionally, ...

  • Dear All, Please the update from ClinicalTrials.gov New Information Page for ClinicalTrials.gov Modernization The ClinicalTrials.gov Modernization  webpage has been created to link to resources relevant to the initiative. The page will ...

  • Hello all, EMA confirmed that the issue has been resolved.  If you were having problems accessing the system earlier today, please try again! ------------------------------ Warm Regards, Francine Lane Vice President, Global Transparency TrialScope ...

  • Please join us for the CTD Community call on our monthly conference call on Tuesday, January 14th at 10am EST.     This month, in addition to our update from the NIH/NLM and EMA, we'll discuss the new California Consumer Privacy Act. Date:  Tuesday, ...

  • Dear all, Please see below update from ClinicalTrials.gov, posted on January 07, 2020: ClinicalTrials.gov Modernization RFI:   The National Library of Medicine (NLM) has issued a   Request for Information (RFI)   seeking public input to guide ...

  • Hi All, The following update was posted on ClinicalTrials.gov PRS under What's New section on December 30, 2019: Changes to Posting Procedures for Applicable Clinical Trials Consistent with requirements under 42 CFR 11.52, NIH must post results ...

  • Hi All, The highlights from EMA Management Board meeting from Dec 2019 have been posted here:  https://www.ema.europa.eu/en/news/ema-management-board-highlights-december-2019-meeting . Below is the update in EU Clinical Trial Information System (CTIS): ...

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