Regulatory Open Forum

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  • 1.  clinicaltrials.gov

    This message was posted by a user wishing to remain anonymous
    Posted 01-Mar-2017 10:48
    This message was posted by a user wishing to remain anonymous

    When it is appropriate / required to register a clinical trial with clinicaltrials.gov?

    Thank you in advance for any feedback.


  • 2.  RE: clinicaltrials.gov

    Posted 01-Mar-2017 10:53
    https://www.clinicaltrials.gov/ct2/manage-recs/background

    ------------------------------
    Julie Omohundro, ex-RAC (US, GS), still an MBA
    Principal Consultant
    Class Three, LLC
    Durham, North Carolina, USA
    919-544-3366 (T)
    434-964-1614 (C)
    julie@class3devices.com
    ------------------------------



  • 3.  RE: clinicaltrials.gov

    This message was posted by a user wishing to remain anonymous
    Posted 02-Mar-2017 11:27
    This message was posted by a user wishing to remain anonymous

    Clinical Trials Registration and Results Information Submission

    This link discusses the Final Rule, which kicked in on January 18th. Changes regarding when to register a trial, and which trials need to be registered are included. 

    Good luck.