Form FDA 1572 Instructional Supplement As commonly used, the term is meant to indicate that each co-investigator is fully responsible for fulfilling all of the obligations of an investigator as identified in 21 CFR 312 60 Thus under 21
Revisiting the Form FDA 1572 - ACRP What is the Form FDA 1572 (Statement of Investigator)? The Statement of Investigator (Form FDA 1572) is a form that is required to be filled for clinical trials involving investigational drugs or biologics
Form FDA 1572: Statement of Investigator - University Hospitals When is Form FDA 1572 Required? • Under the Federal regulations, a 1572 is required for studies of investigational drugs or biologics conducted under an Investigational New Drug (IND) application
INSTRUCTIONS FOR COMPLETING FORM FDA 1572 FORMATION (Select one of the following ) For Phase 1 investigations, a general outline of the planned investigation including the estimated duration of the study and the maximum
Form FDA 1572-Statement of Investigator - National Cancer Institute A form that must be filed by an investigator running a clinical trial to study a new drug or agent The investigator agrees to follow the U S Food and Drug Administration (FDA) Code of Federal Regulations for the clinical trial
U. S. Food and Drug Administration This FDA page provides the Form FDA 1572, Statement of Investigator, for use in clinical trials and related research
Initial IND Application | Clinical Center The intent of the 1572 form is two-fold It is a signed agreement from the Investigator (i e , Principal Investigator) that he she will conduct the research in compliance with FDA regulations
Form FDA 1572: Guidance Document for Form Completion The Statement of Investigator, Form FDA 1572, is an agreement signed by the principal investigator (PI) to provide certain information to the sponsor and assuring that he she will comply with FDA regulations related to the conduct of a clinical investigation of an investigational drug or biologic