HHS Form FDA 3674 2012 free printable template

See OMB Statement on Reverse. Form Approved: OMB No. 0910-0616, Expiration Date: 2-28-2015 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Certification of Compliance, under 42

How to fill out HHS Form FDA 3674

How to fill out HHS Form FDA 3674

1. Obtain a copy of HHS Form FDA 3674, which is available on the FDA website.
2. Fill in the required fields, including the name of the submitter and contact information.
3. Provide the title of the research study and the FDA IND or IDE number, if applicable.
4. Complete the sections related to the type of research and the specific regulatory information requested.
5. Review the form carefully to ensure all information is accurate and complete.
6. Sign and date the form in the designated area.
7. Submit the completed form to the appropriate FDA division as indicated in the instructions.

Who needs HHS Form FDA 3674?

1. Researchers who are conducting clinical trials involving FDA-regulated products.
2. Sponsors of investigational new drug (IND) applications.
3. Institutions or organizations that oversee research involving FDA-regulated products.

People Also Ask about

What is the difference between clinical research and medical research?

Despite their close relationship, clinical research and medical care have become separated by clear boundaries. The purpose of clinical research is to generate generalizable knowledge useful for future patients, whereas medical care aims to promote the well-being of individual patients.

What is the difference between FDA Form 3454 and 3455?

Complete form 3454 if none of the investigators have any FDA required disclosures. Complete form 3455 if any clinical investigator has a financial disclosure that is significant.

What is the difference between Form 1571 and 1572?

Form FDA 1571: Coversheet for all IND submissions. The 1571 must be signed by the Sponsor of the IND. Form FDA 1572: Statement of Investigator. The 1572 must be signed by the Principal Investigator of the clinical trial.

What is a FDA Form 3455?

Form FDA 3455. Disclosure: Financial Interests and Arrangements of Clinical Investigators.

What is the purpose of FDA Form 3454?

Form FDA 3454, or the Financial Certification or Disclosure Statement, is used to submit information regarding clinical investigators who participated in the clinical studies. If no clinical studies were performed, simply state: “no clinical studies were performed to test this device.”

Do you need FDA approval for clinical trials?

Learn more about Clinical Trials. Drug developers, or sponsors, must submit an Investigational New Drug (IND) application to FDA before beginning clinical research.

What is FDA Form 3514?

The form provides the FDA with the information required of applicants who submit certain human drug, biological product, and device applications, including Investigational New Drug Applications (IND) and new clinical protocols submitted as an amendment to an existing IND.

What documentation is required for FDA?

What documents should I provide to FDA? You should provide FDA with entry documentation which may include the following: Bill of Lading (BOL), Airway Bill (AWB), invoice, and purchase order.

What is the FDA Form 3454?

Form FDA 3454, or the Financial Certification or Disclosure Statement, is used to submit information regarding clinical investigators who participated in the clinical studies. If no clinical studies were performed, simply state: “no clinical studies were performed to test this device.”

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What is HHS Form FDA 3674?

HHS Form FDA 3674 is a form used by the U.S. Department of Health and Human Services to provide information about the clinical trial registration and results information as required by the Food and Drug Administration (FDA) Amendments Act of 2007.

Who is required to file HHS Form FDA 3674?

Sponsors of clinical trials who are submitting clinical trial data to the FDA are required to file HHS Form FDA 3674.

How to fill out HHS Form FDA 3674?

To fill out HHS Form FDA 3674, sponsors must provide accurate and complete information regarding the clinical trial in question, including trial identification, results, and compliance with registration requirements. The form can typically be completed online or in a paper format, as directed by the FDA.

What is the purpose of HHS Form FDA 3674?

The purpose of HHS Form FDA 3674 is to ensure that the results of clinical trials are reported to the public, thereby promoting transparency and accountability in clinical research.

What information must be reported on HHS Form FDA 3674?

Information that must be reported on HHS Form FDA 3674 includes the trial's title, identification number, completion date, a summary of the results, and compliance with registration requirements.