For new clinical investigators entering the field or needing a refresher on their current knowledge, this article has been written as a guide for all study centre staff, including CRCs, CRAs, principal investigators and sub-investigators. It is very important to understand the many regulatory documents used in clinical trials – what they mean and how to complete and maintain them. As there may be many more details about which readers may have questions that are not covered in this article, please see the references and resources cited below for more information. 1572 is more than paperwork. This is a binding legal contract between the Principal Investigator (PI), the trial sponsor and the FDA to conduct a clinical trial. That is, if you do not follow it, it can have serious consequences. You`ll get all the resources you need to complete a Form 1572 accurately, including an explanation of the purpose of the form, the consequences of non-compliance, and a detailed breakdown of each section and what it requires. The latest version of FDA Form 1572 is available from www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM074728.pdf. In cases where an FDA Form 1572 is collected shortly before a new version is published, sponsors may use the current version to obtain signed agreements from clinical investigators participating in their clinical trials.

The expiration date specified for use of the form reflects the approval of the form by the U.S. Office of Management and Budget, which meets the requirements of the Paperwork Reduction Act. Although the form has an expiration date, there is no need to deploy a new form after the new version is published with the latest expiration date. Section 6 deals with the transmission of the names of persons registered as sub-investigators. According to 21 CFR 312.3(b), when a study is conducted by a team, the principal investigator is solely responsible for that team formed. All persons who assist the principal investigator and contribute directly to the conduct of the study procedures established in the protocol and to the generation of data must be listed as auditors on the FDA Form 1572. Investigators: If you don`t comply with FDA Form 1572, you can face serious consequences. Despite the specific instructions and guidance on the form, the FDA`s Good Clinical Practice Program (GCPP) asks a variety of questions each year to researchers who don`t know how to fill out a Form 1572.

Naturally, these principal investigators are reluctant to risk non-compliance when the consequences can be severe – from suspending their studies to disqualifying future research. The success of Form 1572 begins with The Investigator`s Guide to Form FDA 1572: Getting the Statement of Investigator Right. You can`t afford to sign one without it. Instead, feel safe agreeing to conduct a study and be sure to follow the investigator`s advice on FDA Form 1572. This page contains links to commonly used clinical trial forms relevant to clinical trials. U.S. FDA Form 1572 The Food and Drug Administration (FDA) is one of many important regulatory documents submitted to the agency as part of clinical trials. Many common mistakes are made when completing and managing Form 1572, so we hope this guide will be useful for new sites, Clinical Research Coordinators (CRCs), Clinical Research Staff (CROs), and other clinical investigators. A: Again, the sponsor selects qualified principal investigators based on their training and experience to conduct the clinical trial, but there are no minimum requirements for the principal investigator to be a physician. In cases where the sponsor selects a principal investigator who is not a physician, a qualified investigator (physician) must be on list 1572 so that the study can make all medical decisions. {4} you even deviate slightly from your FDA Form 1572 – Investigator`s Statement and you become a statistic: This is by far the most serious and common citation after an FDA inspection. This guide serves as a quick read in very simple and clear language that defines what a 1572 is, what a Principal Investigator (PI) commits to sign this document to, how to complete it, how to avoid common mistakes, and how to maintain it for the duration of the study.

In addition, this guide provides a detailed overview of each section of the document. [A downloadable PDF showing these sections more clearly is available here: FDA Form 1572 Illustrations.] U.S. regulations require that FDA Form 1572 be collected from all principal investigators for studies conducted as part of an investigational new drug (IND) application, including clinical trials of an investigational drug or biologic, with the exception of product-related clinical trials (which require a similar form called investigator`s approval). which must be completed as part of an experimental exemption application). 1} Bonus! This guide includes a copy of FDA Form 1572, Frequently Asked Questions – Statement of Investigator`s Guidelines, and other important guidance.