Reply To: Statement of Investigator for non-US Clinical Trial Sites

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December 23, 2020 at 1:59 pm #3913
Janna Gonzalez
Participant

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