Clinical Trial Forms | FDA - U.S. Food and Drug Administration
This page provides links to commonly used clinical trial forms relevant to clinical trials. For other FDA forms, visit the FDA Forms page.
What is the Statement of Investigator, Form FDA 1572? The Statement of Investigator, Form FDA 1572 (1572), is an agreement signed by the investigator to provide certain information to the...
Revisiting the Form FDA 1572 - ACRP
Apr 25, 2019 · 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.
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FORM FDA 1572 - IDSA
FDA 1572 (21 CFR 312.53(c)). 1. NAME AND ADDRESS OF INVESTIGATOR. 2. EDUCATION, TRAINING, AND EXPERIENCE THAT QUALIFY THE INVESTIGATOR AS AN EXPERT IN THE CLINICAL INVESTIGATION OF THE DRUG FOR THE USE UNDER INVESTIGATION. ONE OF THE FOLLOWING IS PROVIDED (Select one of the following.) 3.
• Form FDA 1572 is required for each PI participating in a clinical trial that is to be conducted under a US IND. General Guidance: • The purpose of this document is to provide guidance on completion of the Form FDA 1572 form. This form does not address use for principal investigators outside the US. Use in non-US sites should be
Mar 31, 2019 · (FDA 1572 FORM) Complete the form as indicated and return it to the NCI within six weeks. Use the envelope provided. Please note that the signature and date must be original.
An In-Depth Guide to Form FDA 1572 - CCRPS Clinical Research …
Apr 1, 2023 · Form FDA 1572, officially known as the Statement of Investigator, is a legally binding document required by the United States Food and Drug Administration (FDA) for clinical trials conducted under an Investigational New Drug (IND) application.
Frequently Asked Questions – Statement of Investigator (Form FDA 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...
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 Note: A 1572 is not required for studies not conducted under an IND and is not applicable to investigational device studies.
How to Complete Form FDA 1571 and Form FDA 1572 | FDA
Nov 13, 2019 · FDA Form 1571 and FDA Form 1572 are used for submitting requests for an individual patient expanded access to investigational drugs (including biologics).