FDA Form 1572 Statement of Investigator
FDA Form 1572, also known as the Statement of Investigator, is a form used by the U.S. Food and Drug Administration (FDA) to document that an investigator who is conducting a clinical trial has agreed to follow the regulations governing the study.
The form consists of several parts, including the investigator's name and contact information, the sponsor's name and contact information, the study protocol and objectives, and the investigator's certification that they will comply with the regulations governing the study. Each part is important and must be completed accurately to ensure that the clinical trial is conducted in compliance with the regulations.
The most important fields on the form include the investigator's name, contact information, and certification that they will comply with the regulations governing the study. This information is used to ensure that the study is being conducted in accordance with the regulations and that the investigator is qualified to conduct the study.
This form is compiled by the investigator who is conducting the clinical trial and the sponsor who is funding the study. The parties involved in the document are the investigator, the sponsor, and the FDA.
When compiling the form, it is important to ensure that all information is accurate and up-to-date. This includes providing accurate contact information for the investigator and sponsor, as well as ensuring that the study protocol and objectives are clearly defined.
The advantages of the form include ensuring that clinical trials are conducted in compliance with regulations and that investigators are qualified to conduct the study. It also provides a clear record of the investigator's agreement to comply with the regulations governing the study.
One potential problem when filling out the form is providing inaccurate or incomplete information, which can result in delays in the review process or the rejection of the clinical trial. Additionally, some investigators may find the form confusing or difficult to complete, particularly if they are not familiar with the regulations governing clinical trials.
Related forms include the FDA Form 3454, which is the Certification of Compliance, and the FDA Form 3674, which is the Certification of Compliance for ClinicalTrials.gov. Alternative forms may include institutional review board (IRB) forms or informed consent forms.
The form is submitted to the FDA as part of the clinical trial application process. Once submitted, the form is stored in the FDA's database and is used to ensure that the clinical trial is being conducted in compliance with the regulations.