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This guidance describes the process for completing and maintaining the Statement of Investigator Form (Form FDA 1572) for clinical investigators and their personnel involved in FDA-regulated clinical research studies. It outlines the responsibilities of the Principal Investigator and requirements for the accurate completion of the form.
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How to fill out form fda 1572

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How to fill out form fda 1572

01
Download the FDA Form 1572 from the FDA website.
02
Fill in the name of the clinical investigator at the top of the form.
03
Provide the investigator's address and contact information.
04
List the name of the study title or protocol number.
05
Complete the section about the participating institution.
06
Indicate the name and address of the sponsor or sponsor's representative.
07
Sign and date the form in the designated area.

Who needs form fda 1572?

01
Clinical investigators conducting clinical trials involving investigational drugs or biological products.
02
Sponsors of clinical trials who are required to provide information about trial participants.
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Form FDA 1572, also known as the Statement of Investigator, is a document used by clinical investigators conducting biomedical research involving human subjects to confirm their qualifications and agree to conduct the study according to regulatory requirements.
The principal investigator at a clinical trial site is required to file Form FDA 1572 if they are conducting a study regulated by the FDA, specifically those related to investigational new drugs.
To fill out Form FDA 1572, the investigator must provide personal information, qualifications, institutional affiliation, and details about the study. Specific guidance and instructions can be found in the accompanying instructions provided by the FDA.
The purpose of Form FDA 1572 is to ensure that the investigator is qualified to conduct the clinical trial, to document their commitment to comply with Good Clinical Practice (GCP) regulations, and to provide the FDA with information regarding the study's oversight.
Required information on Form FDA 1572 includes the investigator's name, address, qualifications, study title, signed commitment to follow regulations, and the names of all sub-investigators and key personnel who will be involved in the study.
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