Statement of Investigator for non-US Clinical Trial Sites

[Maria Pedko]

Dear colleagues,

Where do we file Statements of Investigator, which are actually alternatives to form FDA 1572 for non-US clinical trial sites? Should it go to 05.02.09 Investigator Regulatory Agreement or to 05.02.08 Form FDA 1572?

05.02.09 seems to me more logical.

Would you please advise on this?

Thank you a lot and best regards,
Maria

[Eldin Rammell]

The “purpose/description” column is usually the best indicator of filing location.

[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.

[Eldin Rammell]

Hi Maria
I would say it meets this definition: A regulatory statement from the investigator (required by certain health authorities).
Kind regards
Eldin

[Maria Pedko]

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

[Janna Gonzalez]

Hi Maria,

Form FDA 1572 -known as Statement of Investigator -Defines obligations and commitments of the principal Investigator(PI).​

Is a legally binding contract between FDA and PI.​

Must be signed/dated by the Principal Investigator prior to study start and updated throughout the life of the study as needed.​
Purpose:​

To provide the sponsor with information about the PI’s qualifications and the clinical site that will enable to sponsor to establish and document the site an appropriate location at which to conduct the clinical investigation.​

To inform the PI of his/her obligations and obtain the investigator’s commitment to follow pertinent FDA regulations.​

Filing Zone 05.02.08.

Hope this helps!

Regards,
Janna

[Janna Gonzalez]

for non-US Clinical Trial Sites

Oops!

Correct 05.02.09.

Janna

[Maria Pedko]

yes, for non-US Clinical Trial Sites 🙂

So, 05.02.09!

Thank you so much, Janna!

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