Good Clinical Practice: A Question and Answer Guide2024/2025 Edition - 70

GCP: A Question & Answer Reference Guide
2.105 Q. If a sponsor receives a completed Form FDA 1572 with a wet-ink (i.e., signed by hand) investigator
signature and a computer-generated or typed date, is this acceptable and binding?
A. Although this is acceptable, it is better if the principal investigator personally dates the 1572 in Block #11-Date
next to his/her signature. Too frequently, documents are dated (and sometimes backdated) by study coordinators
before the principal investigator signs them. Also, if the date is typed, then one cannot be reasonably assured that
the principal investigator actually signed on that date. Generally, most, if not all, of the other information placed on
this form is typed. It is unwise for an investigator to sign a blank 1572 before key information, such as the names
of subinvestigators and the name and address of the relevant IRB, is added to the form.
In a brief informal response to this question, the FDA stated that, " because the date should reflect when the
investigator actually signed the form, it probably makes more sense for the investigator to date it when he signs it.
However, there is no specific regulatory requirement about placing the date on the form. "
2.106 Q. Has the FDA ever provided general advice on how clinical investigators should complete the 1572,
specifically whether the information provided should be typed or can be handwritten?
A. In its May 2010 guidance titled, " Frequently Asked Questions-Statement of Investigator (Form FDA 1572) "
the FDA outlined some options available to clinical investigators. " The 1572 on FDA's website may be completed
by typing the information directly into the fillable form and printing the completed form, " the agency notes.
" Alternatively, it is acceptable to print the blank form from FDA's website and hand-write or type the information
onto the form. Typed forms are preferable because they are usually more legible. The completed form must be
signed and dated by the investigator (either by hand or using an acceptable electronic method). "
2.107 Q. Often in large hospitals/medical centers a team of physicians, especially residents, fellows and interns
who regularly rotate around the hospital, may be involved in providing care to clinical trial subjects. Do
all of these individuals need to be listed on the Form 1572?
A. In its May 2010 guidance titled, " Frequently Asked Questions-Statement of Investigator (Form FDA 1572), "
the FDA addressed the role of supporting staff. " Hospital staff, including nurses, residents, or fellows and office
staff who provide ancillary or intermittent care but who do not make a direct and significant contribution to the
clinical data, do not need to be listed individually. It is not necessary to include in this section a person with only
an occasional role in the conduct of the research, e.g., an on-call physician who temporarily dealt with a possible
adverse effect or a temporary substitute for any research staff (see ICH E3, Section 6). Concerning staff residents
on rotation, it may be difficult to prospectively identify those individuals who might perform specified protocol
procedures or collect clinical data. Specific names of the rotational staff do not have to be listed in Section #6.
Instead, to successfully address this scenario, the names of rotational individuals and the procedures they are
expected to perform should be included in the clinical study records. This information should also be sent to the
sponsor for submission to FDA in, for example, an information amendment. "
2.108 Q. Do CVs expire in the same way a medical license does when collecting these documents to support
investigators listed on the 1572?
A. This is probably one of the most misunderstood and over-documented issues in GCP. It has over the years
become industry practice to have investigators and subinvestigators sign and date their CVs, to obtain a new,
updated CV every two (2) years and that these documents expire and that updating them is somehow " required. "
The FDA in its May 2010 guidance titled, " Frequently Asked Questions-Statement of Investigator (Form FDA
1572) " , as well as numerous presentations over the years has indicated that FDA regulations do not require a CV
or other statement of qualifications to be signed and dated or be updated during a clinical study. In a presentation
from FDA when asked a similar question, the FDA responded that, " the purpose of collecting the CV (and license)
is to document that at the time the investigator was hired to conduct the trial that he/she is qualified by training,
education and experience. " If the investigator is considered qualified at the beginning of the trial, is it likely that
they would become less qualified as time goes on? So what is the purpose of collecting an updated CV then since
they were determined to be qualified at the beginning of the study? On the contrary, a medical license does need to
be renewed every two to three years in the US, due to state licensing laws, so collecting an updated medical license
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Good Clinical Practice: A Question and Answer Guide2024/2025 Edition

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