The « perfect » FDA 1572 form

Did you ever heard of The FDA1572? Or maybe did you ever used it?

This article will untie the right from wrong on this very useful clinical research form and says everything you need to prepare this form in the … perfect way!

 

What is the FDA 1572 form?

Many thanks to Hélène Marquet for the preparation of this article.

The FDA 1572 is a document signed by the investigator when the promoter decides to place the clinical trial under the « IND » regulation or « Investigational New Drug Application. » The drug is then an experimental drug and is intended to obtain authorization for the USA market. Under the IND regulation, the clinical trial is then conducted according to the standards of 21 CFR Part 312, which is the US federal regulation code governing demands of investigation on new drugs.

The promoter must obtain this document before allowing the participation of an investigator. It provides information on the investigator and site to the promoter, enabling him to assess the ability of the site to conduct the trial. By signing this document, the investigator commits, as part of the clinical trial, to follow the FDA regulations, the US drug agency.

This document should be updated whenever there is a change on the form.

The promoters often recommend the FDA1572 to be signed and dated manually, but, as recommended by the FDA, it is acceptable that this document is signed electronically.

In addition, the FDA recommends this document to be two-sided to ensure that the investigator saw all of its pages.

Now let’s decrypt every part of this form.

Section 1

Section 1 must contain the investigator full name (first and last), possibly followed by the title, degree and / or professional qualification. For example: J *** L ***, MD to indicate that the person is a medical doctor.

The address must match the investigator’s workplace.

Section 2

The Investigator’s resume must be attached in this form. This should mention the training and experience justifying the investigator’s qualification for clinical trials.

The FDA does not imperatively require the resume date and signature because the dated FDA1572 form signature is sufficient to prove its veracity. However, to comply with the GCPs, a dated and signed resume is always requested by the promoter, .

The FDA does not require the study co-investigators resume as it considers that it is the promoter duty to ensure the co-investigators qualifications. However, for studies conducted in France, we must always collect the investigator team members resume of those who take part in the study.

Section 3

This part consists of filling out information on  the places where research will be conducted, such as hospitals, schools and clinics. This includes all places where are seen, patients of the study and where the study material is delivered.

For example:

• Place of administration of experimental drugs (clinic, hospital);
• Place of consultation with the doctor;
• Place of experimental drug storage (pharmacy).

If the protocol states that the experimental drug may be administered to the patient’s home, it is not necessary to add it in the FDA 1572.

Section 4

Register here the name and address of laboratories that will participate in the clinical trial. Are included, the local and centralized medical analysis laboratories, imaging centers, cardiology services, the pathology laboratory, etc. If the laboratory sends samples to a certain joint laboratory or a subcontractor laboratory for specialized examinations (for example to produce the immunophenotyping), only the principal should be listed.

Section 5

In this part, you indicate the name and address of the Ethics Committee that has given its agreement to the study.

Section 6

The objective is to identify people who will assist the investigator and will have an impact on the clinical trial data. The decision of listing a participant or not depends on his level of responsibility: If he carries out important procedures related to the investigation, or if he participates in data collection, he will be then listed.

The hospital staff providing patient care but does not influence the data should not be listed (nurse, etc.). It is not necessary to list a person with a casual role in the research (doctor on call, internal).

There is no particular consensus specifying the persons to be listed or not in this section. It depends on the study, the promoter and / or the CRO with which you work.

In addition to the study co-investigators, it seems indispensable to us, for an oncology study, to list the radiologist as he evaluates the progress or not of the disease.

Similarly, for studies in France neither pharmacists nor the Site Study Coordinator  are mentioned as their activities do not impact on the study data.

It is important to note that all the people mentioned on the section 6 must provide an interest conflict declaration.

Section 7

This section is to notify any studies under IND for which the investigator participates and signs a FDA1572.  The assigned study name and code number must then be entered .

The study for which this form is completed should also be included in this section.

Section 8

This section requires a detailed description of the protocol (number of participants, duration of the study, patient characteristics to which the study addresses …). The study protocol is generally submitted instead of a detailed description.

For Phase IV study, it is not necessary to tick one of two boxes but the investigator should specify in section 7 that the study is a phase IV.

In case you would not have enough room to complete a section. You just have to click on « continuation page » and a new page appears  to complete the section.

Now you know how to fill a FDA1572. Filling this form can sometimes be a real headache, so if you have any doubt or additional suggestions, leave us a comment.

Sources :

Frequently Asked Questions – Statement of Investigator.

The FDA1572 form: http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM074728.pdf

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