What is the purpose of Form FDA 1572?

Form FDA 1572 is known as the Statement of Investigator, which serves a crucial role in the clinical trial process. This form is required by the FDA for sponsor-investigator studies conducted under an Investigational New Drug (IND) application. Its primary purpose is to ensure that the investigators conducting the study are qualified and compliant with GCP and other regulatory requirements.

The form includes key information such as the investigator's qualifications, the site where the study will take place, and the commitments of the investigator to comply with the applicable regulations. By having investigators complete this form, the FDA can assess their capability to manage the study, oversee the safety of participants, and adhere to ethical standards.

This form is significant in establishing accountability and ensuring that all parties involved in the study understand their roles and responsibilities. Its completion is an essential step in maintaining the integrity of the clinical trial and protecting the rights and welfare of the subjects involved.