[Maria Pedko]

Dear colleagues,

Could somebody help with this topic please?

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

[Maria Pedko]

yes, for non-US Clinical Trial Sites 🙂

So, 05.02.09!

Thank you so much, Janna!

[Maria Pedko]

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

[Maria Pedko]

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.

[Author]

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