Form Fda 1572 Statement Of Investigator

• The Form FDA 1572 is a binding agreement for investigators in clinical trials under an Investigational New Drug (IND) application.
• It ensures the investigator’s commitment to adhere to FDA regulations and the study protocol.
• Key responsibilities include protecting patient rights, ensuring data integrity, and reporting adverse events.
• The form is essential for maintaining the ethical and scientific standards of clinical research.

What is Form FDA 1572 Statement of Investigator?

The Form FDA 1572 Statement of Investigator is a critical regulatory document required by the U.S. Food and Drug Administration (FDA) for clinical investigations conducted under an Investigational New Drug (IND) application. This form serves as a formal agreement in which the clinical investigator commits to conducting the study in accordance with the investigational plan, FDA regulations, and the principles of Good Clinical Practice (GCP). The primary purpose of FDA Form 1572 is to provide the sponsor with information about the investigator’s qualifications and the clinical site, and to assure the FDA that the investigator will comply with all applicable regulations.

By signing the Form FDA 1572, an investigator agrees to undertake specific responsibilities to ensure the safety of human subjects and the integrity of the collected data. It acts as a comprehensive FDA 1572 Statement of Investigator guide, detailing the legal and ethical obligations of the investigator. While the form itself is submitted to the sponsor, not directly to the FDA, it is maintained by the sponsor as part of the IND application and is subject to FDA review during inspections.

Key Requirements and Investigator Responsibilities for Form FDA 1572

The FDA 1572 requirements for investigators are extensive and designed to safeguard trial participants and ensure the reliability of study results. When signing the Form FDA 1572, an investigator makes several crucial commitments. These responsibilities are fundamental to the ethical and scientific conduct of clinical trials and are outlined in 21 CFR Part 312, Subpart D.

Key responsibilities include:

• Conducting the Study: Adhering strictly to the investigational plan (protocol) and all applicable FDA regulations.
• Informed Consent: Ensuring that all subjects receive a full explanation of the study and provide voluntary informed consent before participation.
• IRB Review: Obtaining and maintaining Institutional Review Board (IRB) approval for the study protocol, informed consent forms, and any amendments.
• Reporting Adverse Events: Promptly reporting all serious adverse events to the sponsor.
• Record Keeping: Maintaining accurate, complete, and current records of the investigation, including case histories, drug disposition, and subject data, for a specified period.
• Drug Accountability: Ensuring that the investigational drug is used only for subjects under the investigator’s supervision and is properly stored and accounted for.
• Qualified Staff: Delegating study-related tasks only to qualified staff and providing adequate supervision.

These commitments underscore the investigator’s central role in protecting human subjects and generating valid scientific data, which is paramount for the development of new medical treatments.