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INSTRUCTIONS FOR FILLING OUT FORM FDA 1571 INVESTIGATIONAL NEW DRUG APPLICATION (IND) (The field numbers below correspond to the numbered boxes on the Form FDA 1571) Field 1: NAME OF SPONSOR The sponsor

How to fill out form 1572

How to fill out Form FDA 1571:

1. Begin by gathering all the necessary information and documentation required for Form FDA 1571. This may include details about the investigational new drug (IND) application, the sponsor of the study, and any other relevant information.
2. Start by accurately completing the top section of the form, which includes details such as the active IND number, the study title, and the name and address of the sponsor. Make sure to double-check all the information for accuracy.
3. Move on to Section 1 of Form FDA 1571, which focuses on the investigator(s) involved in the study. Fill in the required information for each investigator, including their name, address, qualifications, and affiliations. If there are multiple investigators, provide this information for each one.
4. Proceed to Section 2, which deals with the study title, protocol number, and other vital study details. Provide accurate information about the IND application number, the study title, and the phase of the investigation. Include any pertinent dates as well.
5. In Section 3, provide information about the proposed study site(s) where the investigation will be conducted. Include the name, address, and contact information for each site involved. If there are multiple study sites, provide this information for each one.
6. Next, complete Section 4, which focuses on clinical investigators who are not practicing in the United States. If applicable, provide the necessary information about these investigators, including their qualifications, affiliations, and any ongoing or previous disqualifications.
7. In Section 5, provide information about the institutional review boards (IRBs) that will be involved in overseeing the study. Include the name, address, and contact information for each IRB. If there are multiple IRBs involved, provide this information for each one.
8. Finally, review the completed Form FDA 1571 for accuracy and completeness. Double-check that all the required sections have been filled out correctly and that all the information provided is up to date.

Who needs Form FDA 1571?

1. Sponsors of clinical investigations who are applying for an Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) need to fill out Form FDA 1571.
2. Investigators involved in the study, both in the United States and internationally, also need to provide their information on Form FDA 1571.
3. Institutional Review Boards (IRBs) that will oversee the study and ensure its ethical and regulatory compliance may also need to provide their details on this form.

In summary, Form FDA 1571 serves as a crucial document for sponsors, investigators, and IRBs involved in the IND application process. Properly filling out this form ensures accurate and comprehensive information is provided to the FDA for review and approval.

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What is form fda 1571?

Form FDA 1571 is a document that must be submitted to the Food and Drug Administration (FDA) by sponsors or applicants seeking approval to conduct clinical trials of new drugs or biologics.

Who is required to file form fda 1571?

Sponsors or applicants seeking approval to conduct clinical trials of new drugs or biologics are required to file form FDA 1571.

How to fill out form fda 1571?

Form FDA 1571 can be filled out electronically through the FDA's electronic submission gateway or manually by following the instructions provided on the form.

What is the purpose of form fda 1571?

The purpose of form FDA 1571 is to provide the FDA with essential information about the proposed clinical trial, including the study design, objectives, and investigational drug or biologic.

What information must be reported on form fda 1571?

Form FDA 1571 requires information such as study protocol, investigator credentials, patient population, and drug manufacturing details to be reported.