Get the free FDA bFormb 1572 - Statement of Investigator - SWOG - swog

This form can be completed on the screen, then printed and faxed, or printed and completed offline. DEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION STATEMENT

How to fill out fda bformb 1572

How to fill out FDA Form 1572?

1. Start by downloading the FDA Form 1572 from the official FDA website or obtain a copy from your local FDA office.
2. Provide the necessary information at the top of the form, including the study title, protocol number, investigator's name, and contact details.
3. Indicate the investigator's qualifications and experience in the designated section. Include any relevant certifications or licenses that demonstrate the investigator's competence.
4. Fill in the study site information, including the name and address of the institution where the research will take place.
5. Identify any subinvestigators or colleagues assisting with the study and provide their contact information.
6. Read and understand the Investigator's Agreement section carefully. This section outlines the investigator's responsibilities and obligations throughout the study. Sign and date the agreement to confirm your commitment.
7. Once the form is complete, review all the provided information to ensure accuracy and completeness. Make any necessary adjustments or revisions.
8. Keep a copy of the filled-out FDA Form 1572 for your records and submit the original to the appropriate FDA representative as specified in your research protocol.

Who needs FDA Form 1572?

1. Clinical investigators conducting studies involving investigational new drugs (INDs) or device investigations under the jurisdiction of the Food and Drug Administration (FDA) need FDA Form 1572.
2. Sponsors or sponsors-investigators involved in clinical trials also require FDA Form 1572.
3. The form serves as a legal binding agreement between the investigator and the FDA, outlining the responsibilities and commitments of the investigators in conducting the study according to the Good Clinical Practice (GCP) guidelines.

Remember, it is essential to consult the specific regulations and guidelines provided by the FDA and seek advice from regulatory experts or institutional review boards (IRBs) to ensure compliance and accuracy when filling out FDA Form 1572.

For pdfFiller’s FAQs

What is fda bformb 1572?

FDA Form 1572 is a document that is used by investigators who are conducting clinical trials to provide assurance to the FDA that they will comply with the regulations governing the conduct of clinical trials.

Who is required to file fda bformb 1572?

Investigators who are conducting clinical trials are required to file FDA Form 1572.

How to fill out fda bformb 1572?

FDA Form 1572 must be filled out by providing all the required information, including the investigator's name, address, qualifications, and agreement to conduct the trial in compliance with the regulations.

What is the purpose of fda bformb 1572?

The purpose of FDA Form 1572 is to provide assurance to the FDA that the investigator will comply with the regulations governing the conduct of clinical trials.

What information must be reported on fda bformb 1572?

The FDA Form 1572 must include the investigator's name, address, qualifications, and agreement to conduct the trial in compliance with the regulations.

How do I edit fda bformb 1572 in Chrome?

Install the pdfFiller Chrome Extension to modify, fill out, and eSign your fda bformb 1572, which you can access right from a Google search page. Fillable documents without leaving Chrome on any internet-connected device.

Can I sign the fda bformb 1572 electronically in Chrome?

Yes. By adding the solution to your Chrome browser, you may use pdfFiller to eSign documents while also enjoying all of the PDF editor's capabilities in one spot. Create a legally enforceable eSignature by sketching, typing, or uploading a photo of your handwritten signature using the extension. Whatever option you select, you'll be able to eSign your fda bformb 1572 in seconds.

Can I create an electronic signature for signing my fda bformb 1572 in Gmail?

When you use pdfFiller's add-on for Gmail, you can add or type a signature. You can also draw a signature. pdfFiller lets you eSign your fda bformb 1572 and other documents right from your email. In order to keep signed documents and your own signatures, you need to sign up for an account.