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Data Integrity

Home » Topics » Clinical Trials » Data Integrity
  • December 18, 2017

    FDA Invites Comments on Clinical Data Template

    The FDA is seeking public comment on a proposed template for the submission of electronic data to the agency from clinical trials.
  • November 16, 2017

    FDA Guidance on Device Trial Demographics Targets Transparency, Data Consistency

    New medical device clinical trial guidance aims to improve participation diversity and increase data consistency and transparency, FDA officials said in an Oct. 31 webinar.
  • November 9, 2017

    FDA Invites Comments on Clinical Data Template

    The agency will review the proposed template.
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  • November 7, 2017

    FDA Invites Comments on Clinical Data Template

  • April 13, 2016

    FDA Sends Warning Letters to CIs for Deviating from Protocols

  • April 7, 2016

    FDA Sends Warning Letters to CIs for Deviating from Protocols

  • June 12, 2015

    EMA Clarifies Clinical Requirements for Fixed-Dose Combination Drugs

  • June 11, 2015

    Pediatric Disease Voucher Worth $245 Million to Sanofi

  • June 11, 2015

    EMA Confirms Suspension of Drugs Over Flawed Studies

  • June 11, 2015

    Chinese Device Trial Guidelines Exempt ‘Equivalent’ Products

  • June 11, 2015

    CXL-USA Warned Over Unapproved Clinical Trial

  • June 11, 2015

    Pediatric Extrapolation Guidance Applies to New, Existing Devices

  • June 11, 2015

    CRO Analytics Sets Sights on Site Quality

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