What is a FDA Form 1572?

The 1572 has two purposes: 1) to provide the sponsor with information about the investigator’s qualifications and the clinical site that will enable the sponsor to establish and document that the investigator is qualified and the site is an appropriate location at which to conduct the clinical investigation, and 2) to …

Who completes Form FDA 1572?

sponsor
When new investigators are assigned to a clinical investigation under an investigational new drug application (IND), the sponsor completes and signs a Form 1572 before allowing the investigator to get involved in the clinical investigation.

When should I update Form 1572?

When Must the Form be Updated or a New One Completed? In cases when a new site is added or of replacement of an investigator at an existing site, a 1572 must be submitted to the FDA within a 30-day window of the site’s/investigator’s addition/replacement.

How to register a CTEP with the FDA?

A AB FDA Form 1572 Financial Disclosure Form NCIBiosketch (education, training, employment, certification, and license) HSP/GCP training Agent Shipment Form (if applicable) CV (optional) New Registration Types – Documentation Requirements IVR NPIVR AP A AB Registration Documents: FDA Form 1572

What are the instructions for Form FDA 1572?

INSTRUCTIONS FOR COMPLETING FORM FDA 1572 STATEMENT OF INVESTIGATOR 10. DATE (mm/dd/yyyy) 11. SIGNATURE OF INVESTIGATOR Sign WARNING : A willfully false statement is a criminal offense. U.S.C. Title 18, Sec. 1001.) The information below applies only to requirements of the Paperwork Reduction Act of 1995.

How to complete statement of investigator form 1572?

It describes how to complete the Statement of Investigator form (Form FDA 1572). The Food and Drug Administration (FDA or agency) has received a number of questions about Form FDA 1572. The most frequently asked questions are answered below.

How is form 1572 forwarded to the sponsor?

FORWARD THE COMPLETED FORM AND OTHER DOCUMENTS BEING PROVIDED TO THE SPONSOR. The sponsor will incorporate this information along with other technical data into an Investigational New Drug Application (IND). INVESTIGATORS SHOULD NOT SEND THIS FORM DIRECTLY TO THE FOOD AND DRUG ADMINISTRATION. INSTRUCTIONS FOR COMPLETING FORM FDA 1572