A vital document required when carrying out a clinical trial is FDA Form 1572 Statement of Investigator. It is a contract between the Principal Investigator (PI) and the FDA. FDA Form 1572, or just 1572, has all details of the subjects in the research, as well as the commitments the PI, who oversees the trial, has to undertake to the FDA. This commitment concerns meeting all the requirements from the FDA as they relate to the trial.
When the PI signs the FDA Form 1572, which relates to IND studies, or the “Statement of the Investigator, which is meant for IDE studies; she undertakes a commitment that she will comply with all the appropriate regulations and will be liable to facing legal action in the event of failing to do so. Hence, the FDA Form 1572 is a strongly legally binding document which sets out the terms of the commitment between the PI and the FDA.
The FDA has created the form 1572 with two main intentions:
It aids the FDA in gauging the PI’s suitability for overseeing the study, as it requires the latter to declare criteria related to this, such as experience and qualification. It also helps it understand the purpose of the study and the suitability of its methods to help it achieve its aims. Not only the FDA, but also the sponsor of the study can get this information from the form 1572.
Additionally, the FDA Form 1572, by taking an undertaking from the Principal Investigator that she will meet the requirements set out by the FDA during the trial; criminalizes the failure on the part of the PI to meet these conditions. It treats this as giving false statements, which empowers the agency to proceed legally against the PI under 18 USC 1001. When the sponsor selects the Principal Investigator to conduct a clinical trial as an investigational new drug (IND) that meets the criteria set out in 21 CFR 312.53 (c); this form has to be submitted.
Other documents accompanying the 1572
In addition, the following documents, which set out the general and specific responsibilities that the Investigators have when conducting a clinical trial; have to accompany the FDA Form 1572:
- 21 CFR 312.50: contains the General Responsibilities of Investigators
- 21 CFR 812.100: sets out the Responsibilities of Investigators for Biologics
- 21 CFR 812.110: details the Responsibilities of Investigators for devices.
Get to understand the workings of FDA Form 1572
With the FDA Form 1572 being of crucial importance, compliance with it is not something that a sponsor or a PI can take lightly. Meeting the regulatory requirements set out in this document is in the interest of everyone concerned.
It is with the purpose of familiarizing the aspects relating to FDA Form 1572 that Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, is organizing a webinar.
The speaker of this webinar, Charles H. Pierce, a consultant in the Clinical Research/Drug-Device Development arena, will offer insights into the nature of the due diligence that investigators and their staff have to take in meeting their regulatory and legal responsibilities.
Please register for this highly educative webinar by visiting Form FDA 1572 Seriously
FDA Form 1572 contains nine statements, seven out of which begin with “I agree”. Some of the essential elements named in the 1572 include:
- 21 CFR 50 (Protection of Human Subjects)
- 21 CFR 56 (Institutional Review Boards)
- 21 CFR 312 (Investigational New Drug Application/IND)
- For Device studies, 21 CFR 812 (Investigational Device Exemptions/IDE) is added in place of 21 CFR 312.
Also, additional responsibilities are outlined in GCP Guidelines of E6 (4) and the Compliance Program Guidance Manual (CPGM) 7348.811. In addition to complying with the principles of Good Clinical Practices (GCP); the PI and sponsors are advised to also use their discretion.
At this session, the speaker will offer complete clarity on these aspects. The following areas will be covered at this webinar:
- The Investigators role in the clinical research process
- The difference between AEs and SAEs and the reporting requirements of the investigator
- Why the investigator maintains a list of staff signatures?
- Why the investigator files the signed and dated protocol?
- Why the investigator is responsible for the IC process?
- What is the legal language of the FDA Form 1572 or Device equivalent?
- Why is Financial Disclosure information important?
- What is the history of the drug / device regulations?
For updates from this please https://goo.gl/forms/SNAcsW8rLKPrzxLD2