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Begin by filling out Section 1, which requires your name and address as the Principal Investigator. Ensure all fields are completed accurately.
In Section 2, provide your education, training, and experience. Select either 'Curriculum Vitae' or 'Other Statement of Qualifications' as applicable.
For Section 3, enter the name and address of the medical school, hospital, or research facility where the clinical investigation will take place.
Continue to Section 4 to list any clinical laboratory facilities that will be used in the study. Fill in all required details.
In Section 5, provide information about the Institutional Review Board (IRB) responsible for reviewing and approving your study.
Complete Sections 6 through 9 by entering names of sub-investigators, protocol information, and commitments regarding the conduct of the study.
Finally, sign and date the form in Section 10 before forwarding it to your sponsor for incorporation into an Investigational New Drug Application (IND).
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Form FDA 1572 serves two main purposes: The first is to provide the sponsor with the investigators qualifications and information about the clinical site. The second purpose is to inform and clarify the obligations of the investigator and to acquire investigators commitment to follow pertinent FDA regulations.
What is the FDA 1572 form?
A form that must be filed by an investigator running a clinical trial to study a new drug or agent. The investigator agrees to follow the U.S. Food and Drug Administration (FDA) Code of Federal Regulations for the clinical trial.
What is the 1572 rule?
Under FDA regulations, a 1572 is only required for studies of investigational drugs and biologics conducted under an IND. It is not required for studies that are not done under an IND and is not applicable to investigational device studies.
Who completes Form FDA 1572?
When new investigators are assigned to a clinical investigation under an investigational new drug application (IND), the sponsor completes and signs a Form 1572 before allowing the investigator to get involved in the clinical investigation.
Who submits form FDA 1572?
In general, if an individual is directly involved in the performance of procedures required by the protocol, and the collection of data, that person should be listed on the Form FDA 1572.
fda 1572 form
FDA 1572 Form PDFFDA Form 1572 templateFDA 1572 guidance 2024What is the purpose of FDA Form 1572Form FDA 1572 Statement of InvestigatorFDA 1572 Form 2023FDA Form 3454FDA guidance 1572 Questions and Answers
There are two instances where the investigator must complete and sign a new 1572: When a new protocol is added and the investigator must employ that protocol. When a new investigator is added to the investigation(21 CFR 312.53(c))
Can FDA Form 1572 be signed electronically?
For documents created electronically on a file system, signatures may be obtained electronically if a mechanism is available to the signer. For example, an FDA 1572 Statement of Investigator form can be filled out within Adobe and signed using an available digital certificate outside of any document management system.
by D GUIDANCE 2015 Form FDA 1572 Statement of Investigator (Form FDA. 198 1572). As an investigator, a sponsor-investigator is also required to sign Form FDA 1572. By. 199
It describes how to complete the Statement of Investigator form (Form FDA 1572). The Food and Drug Administration (FDA or agency) has received a number of
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