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  • February 11, 2022 at 7:39 pm in reply to: TMF RM_EU Clinical Trials Regulation 536/2014 #4393
    Maria PedkoMaria Pedko
    Participant

    Dear colleagues,

    Could somebody help with this topic please?

    Thank you a lot for all your help,
    Best regards,
    Masha

    December 23, 2020 at 4:02 pm in reply to: Statement of Investigator for non-US Clinical Trial Sites #3915
    Maria PedkoMaria Pedko
    Participant

    yes, for non-US Clinical Trial Sites 🙂

    So, 05.02.09!

    Thank you so much, Janna!

    December 23, 2020 at 1:42 pm in reply to: Statement of Investigator for non-US Clinical Trial Sites #3912
    Maria PedkoMaria Pedko
    Participant

    Thank you a lot, Eldin! My thoughts are the same!

    December 23, 2020 at 9:22 am in reply to: Statement of Investigator for non-US Clinical Trial Sites #3910
    Maria PedkoMaria Pedko
    Participant

    Dear Eldin,

    Thank you very much for your reply!

    For “Form FDA 1572” we have the following “purpose/description”: “For IND trial, 1572 must be completed globally for FDA submission”.

    For “Investigator Regulatory Agreement” the “purpose/description” is this: “A regulatory statement from the investigator required by certain health authorities e.g. includes but is not limited to ‘Qualified Investigator Undertaking’ form and ‘Clinical Trial Site Information’ form required by Health Canada”.

    Statements of Investigator for non-US clinical trial sites are not mentioned there, that’s why I’m asking about the correct filing location.

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