Good Clinical Practice: A Question & Answer Reference Guide - May 2012 - (Page 97)

Section 3: Form FDA-1572/Statement of the Investigator 3.1 Q. In May 2010, the FDA issued a new guidance/information sheet entitled, “Frequently Asked Questions—Statement of Investigator (Form FDA 1572).” Why did the FDA see a new guidance as necessary given that the Form FDA 1572 has been in use for so many years? A. The agency did not address this question directly in the original July 2008 draft guidance or the May 2010 final guidance, except to say that it “has received a number of questions about the Form FDA 1572.” In August 2008 comments in “The Form FDA 1572: A Reference Guide for Clinical Researchers, Sponsors, and Monitors” (www. barnettinternational.com), however, one agency official noted that, “a large percentage of the questions that we receive in the [FDA’s Good Clinical Practice Program] pertain to the 1572 and how it should be completed.” There may be additional reasons why the FDA sought to issue a new guidance specifically on the 1572, aside from several long-standing questions and continuing uncertainty regarding some aspects of the form, such as which individuals should be identified as subinvestigators (see Q3.16). Another area of long-standing uncertainty—when and if foreign clinical investigators are required to complete and sign the 1572—seemed to enter a new phase in February 2008, when Norway became the first foreign government to warn its clinical investigators not to sign the 1572 for clinical trials conducted in the country. So it is not likely a coincidence that the FDA used a few pages of the draft guidance to outline its 1572-related requirements for clinical investigators located outside the United States (see Q3.5-Q3.10). The implications of the new FDA guidance are captured in the questions and answers throughout this section. 3.2 Q. Because it is used for a few different purposes, there is uncertainty in some cases about the Form FDA 1572-Statement of Investigator, in particular when its use and submission is mandatory. What is the 1572’s regulatory purpose, and in what ways is the form used in practice? A. The 1572 itself declares that, “No investigator may participate in an investigation until he/she provides the sponsor with a completed, signed Statement of Investigator, Form FDA 1572.” And FDA regulations at 21 CFR 312.53(c)(1) add that, “Before permitting an investigator to begin participation in an investigation, the sponsor shall obtain the following: (1) A signed investigator statement (Form FDA-1572). . . .” Therefore, the Form 1572 is a document that an investigator must submit to the study sponsor. According to the FDA’s May 2010 guidance entitled, “Frequently Asked Questions—Statement of Investigator,” 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 study; and (2) to inform the investigator of his/her obligations and obtain the investigator’s commitment to follow pertinent FDA regulations.” Through the 1572 Form and the attachments typically sent with it, an investigator provides a sponsor with, among other things, information on his or her education, training, and experience (CV or other statement of qualifications) that qualifies him or her to undertake the clinical investigation, information on the relevant facility, IRB, and subinvestigators (names), protocol information, and the investigator’s commitment to conduct the study in accordance with the protocol and FDA regulations. So where is there uncertainty about the 1572’s use? In many cases, companies submit the completed and signed 1572s to the FDA in the original IND and subsequently when new investigators are added to a study. IND applicants and holders do this as a convenient way of fulfilling an FDA requirement at 21 CFR 312.23(a)(6)(iii)(b), which calls for a clinical trial protocol submitted in an IND to provide “the name and address and a statement of the qualifications (CV or other statement of qualifications) of each investigator.” Because this has become such a common practice, some incorrectly assume that it is an FDA requirement. In fact, the IND form (Form FDA 1571) explicitly gives sponsors the option of fulfilling 312.23(a)(6)(iii)(b) by submitting either “Investigator data [21 CFR 312.23(a)(6)(iii)(b)] or completed Form(s) FDA 1572.” In informal correspondence on this issue, the FDA stated that, “People seem to obsess over the 1572. We wonder how many people realize that the 1572 is not even required to be submitted to the FDA. In theory, we [at the FDA] 97 http://www.barnettinternational.com http://www.barnettinternational.com

Table of Contents for the Digital Edition of Good Clinical Practice: A Question & Answer Reference Guide - May 2012

Good Clinical Practice: A Question & Answer Reference Guide - May 2012
Table of Contents
Introduction
Section 1: GCP Regulations, Standards and Guidelines for Clinical Research
Section 2: Investigators/Sites
Section 3: Form FDA-1572/Statement of the Investigator
Section 4: Study Sponsors and Clinical Trial Monitoring
Section 5: Informed Consent
Section 6: Source Data/Documentation
Section 7: Clinical Trial Protocols/Protocol Changes/Protocol Violations
Section 8: Institutional Review Boards
Section 9: Drug/Study Safety and Safety Reporting
Section 10: FDA Inspections, Quality Assurance Activities, and Study Auditing
Section 11: Computerized Systems, e-Clinical Trials, and Electronic Records Rules
Section 12: Patient Recruitment
Section 13: Conflicts of Interest/Financial Disclosure
Section 14: The HIPAA Privacy Rule and FDA-Regulated Clinical Trials
Section 15: Drug Accountability, Administration, and Labeling
Section 16: Fraud, Negligence, and Regulatory Non-Compliance
Section 17: Subject Diaries
Section 18: GCP and Clinical Research Standards in the European Union and An Interview with Fergus Sweeney, Ph.D., EMA Head of Sector, Compliance and Inspection
Section 19: Clinical Trial and GCP Standards in Selected Leading Countries/Regions: Latin America, China, Russia, Ukraine, and India
Section 20: GCP Compliance Statistics and Trends
21 CFR Part 11 — Electronic Records; Electronic Signatures
21 CFR Part 50 — Protection of Human Subjects
21 CFR Part 54 — Financial Disclosure by Clinical Investigators
21 CFR Part 56 — Institutional Review Boards
21 CFR Part 312 — Investigational New Drug Application
ICH Consolidated Guideline on Good Clinical Practice (E6)
ICH Guideline on Clinical Safety Data Management (E2A)
European Union Clinical Trials Directive
European Union Good Clinical Practice Directive

Good Clinical Practice: A Question & Answer Reference Guide - May 2012