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  • 1.  Definition of Registration in ct.gov

    This message was posted by a user wishing to remain anonymous
    Posted 12-Apr-2021 11:10
    This message was posted by a user wishing to remain anonymous

    Strange questoin but can someone elobarate on the exact definition of the word "registration" for the rule that Applicable Clinical Trials to be registered within 21 days of enrollment of the first participant in the clinicaltrial.gov  [and]  in addition, the International Committee of Medical Journal Editors and other journals require registration of clinical trials prior to enrollment of the first participant.

    Basically - does the registration means the (1) initial submission of the information to ct.gov or (2) issuance of the NCT number or (3) posting online?  


  • 2.  RE: Definition of Registration in ct.gov

    Posted 13-Apr-2021 09:22
    Since the NCT Number is issued when the submission is made public, that is how I would define "registration." I wouldn't use initial submission as it may be some time to satisfy the NIH requirements for appropriate and adequate information as part of the registration.

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    Glen Park PharmD
    Vice President, Regulatory Affairs and Quality Assurance
    New York NY
    United States
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