Get the free Form FDA 1572 (PDF - 208KB) - Food and Drug Administration - fda

Form Approved: OMB No. 0910-0014. Expiration Date: ... a completed, signed Statement of Investigator, Form. FDA 1572 (21 CFR 312.53(c)). 1. NAME AND .... Restaff FDA.HHS.gov. DO NOT SEND ...

How to fill out form fda 1572 pdf

How to fill out form FDA 1572 PDF:

1. Download the form: Go to the FDA's website and search for "Form FDA 1572." Locate the PDF version of the form and download it to your computer.
2. Read the instructions: Before starting to fill out the form, carefully read the instructions provided on the first page. These instructions will guide you through each section of the form and explain what information to provide.
3. Personal Information: Begin by filling out the personal information section at the top of the form. This includes your name, address, contact details, and the name of the institution or organization you represent.
4. Investigator Information: Provide the investigator's name, address, telephone number, and qualifications. This is the individual who will be conducting the clinical research or trial.
5. Investigational New Drug (IND) Information: Fill out the sections related to the IND, including the IND number, the name of the drug being used in the study, and the protocol title or identification number.
6. Financial Disclosure: Answer the questions in the financial disclosure section honestly and accurately. This section aims to determine whether the investigator or institution has any financial interests related to the study.
7. Certification and Agreement: Carefully read the certification and agreement section and sign and date the form to affirm that all the information provided is true and complete.

Who needs form FDA 1572 PDF:

1. Clinical Investigators: Clinical investigators who are conducting drug research or trials under an investigational new drug application (IND) need to fill out Form FDA 1572. This form helps the FDA ensure that the study is being conducted ethically and in compliance with regulations.
2. Sponsors and Contract Research Organizations (CROs): Sponsors and CROs involved in clinical research may also need the form. They may use it to gather information about the investigators involved in the study and to fulfill their reporting obligations to the FDA.
3. Institutional Review Boards (IRBs): IRBs, which oversee and review clinical research protocols, may require Form FDA 1572 as part of their approval process. They use the information provided in the form to assess the qualifications and potential conflicts of interest of the investigators.

Overall, anyone involved in clinical research or trials under an IND should familiarize themselves with Form FDA 1572 and its requirements. It is important to complete and submit the form accurately and in a timely manner to ensure compliance with FDA regulations.

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What is form fda 1572 pdf?

Form FDA 1572 is a document used in clinical research that provides information about the investigator(s) who will be conducting the study.

Who is required to file form fda 1572 pdf?

Investigators who will be conducting clinical studies involving investigational new drugs (INDs) or devices (IDEs) are required to file Form FDA 1572.

How to fill out form fda 1572 pdf?

Form FDA 1572 must be filled out with information about the investigator(s) including name, address, qualifications, and signature.

What is the purpose of form fda 1572 pdf?

The purpose of Form FDA 1572 is to provide the FDA with information about the investigator(s) who are responsible for the conduct of a clinical study.

What information must be reported on form fda 1572 pdf?

Form FDA 1572 requires reporting of the name, address, qualifications, and agreement of the investigator(s) to conduct the clinical study.