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How to fill out form FDA 1572-21:

01
Opening the form: Begin by opening the FDA Form 1572-21, which can be found on the official website of the U.S. Food and Drug Administration (FDA). It is essential to use the most current version of the form to ensure compliance.
02
Personal Information: Fill in the personal information section accurately. This includes providing your full name, address, contact information, and professional qualifications. It is important to provide up-to-date information to establish credibility.
03
Investigator Information: If you are the investigator, provide your information in this section. Include your qualifications, experience, and contact details. If you are completing the form on behalf of an investigator, ensure that all the necessary information is accurately filled out.
04
Study Information: Fill in the study information section, which includes the protocol title, sponsor name, and the Institutional Review Board (IRB) approving the study. Additionally, include any other relevant study details as requested on the form.
05
Signature and Certifications: Ensure that the investigator or the authorized representative signs and dates the form. By signing, they certify that they will conduct the study and comply with all applicable regulations and guidelines.
06
Attachments and Addenda: Review the form to determine if any attachments or addenda are required. These may include additional study-related documents, informed consent forms, or essential study materials. Make sure that all necessary documents are appended appropriately.

Who needs form FDA 1572-21?

01
Principal Investigators: The form is primarily meant for principal investigators who are involved in conducting clinical investigations on investigational drugs or biological products regulated by the FDA. They need to complete the FDA Form 1572-21 to provide essential information about themselves and their study.
02
Sponsors: Sponsors or their authorized representatives may also need to complete this form. It allows them to provide information about the investigator involved in the study they are sponsoring.
03
Institutional Review Boards: Institutional Review Boards (IRBs) reviewing the study protocols might also require the completion of form FDA 1572-21. This helps them assess the qualifications and commitments of the investigators involved in the study.
Overall, it is crucial to fill out form FDA 1572-21 accurately and completely to ensure compliance with FDA regulations and guidelines. This form acts as a binding agreement between the investigator, the sponsor, and the FDA, and it is an essential component of the clinical investigation process.
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Form FDA 1572 is a document used in clinical trials to collect information about the investigator conducting the study.
The principal investigator conducting the clinical trial is required to fill out and file Form FDA 1572.
Form FDA 1572 must be filled out with accurate information about the investigator's qualifications and commitments to the clinical trial.
The purpose of Form FDA 1572 is to document the agreement between the clinical trial's sponsor and the investigator conducting the study.
Form FDA 1572 requires information about the investigator's qualifications, their commitment to conducting the clinical trial, and any potential conflicts of interest.
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