Last updated on May 6, 2026
FDA 1572 2013 free printable template
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What is FDA 1572
The FDA Form 1572 Statement of Investigator is a medical consent form used by clinical investigators to document their qualifications and commitments for conducting drug clinical investigations.
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Who needs FDA 1572?
Explore how professionals across industries use pdfFiller.
FDA 1572 is needed by:
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Clinical investigators conducting drug trials
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Healthcare professionals involved in clinical research
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Pharmaceutical companies sponsoring clinical trials
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Regulatory bodies overseeing drug investigations
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Research institutions and universities
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Patients participating in clinical studies
Comprehensive Guide to FDA 1572
What is the FDA Form 1572 Statement of Investigator?
The FDA Form 1572, also known as the Statement of Investigator, plays a critical role in clinical drug trials. This form is essential for ensuring that investigators comply with regulatory requirements during clinical investigations. By submitting this form, clinical investigators confirm their commitments to conduct studies in a manner that meets all relevant regulations, emphasizing its importance in maintaining standards in clinical research.
Purpose and Benefits of the FDA Form 1572 Statement of Investigator
The FDA Form 1572 serves not only as a compliance tool but also offers several benefits to various stakeholders involved in clinical trials. This form encapsulates the regulatory requirements for clinical trials, guiding investigators, sponsors, and patients. By ensuring that all parties understand their responsibilities, this form enhances the overall integrity of the clinical investigation process.
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Clarifies the responsibilities of clinical investigators.
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Facilitates informed consent for patients involved in drug trials.
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Streamlines communication between sponsors and investigators.
Key Features of the FDA Form 1572 Statement of Investigator
The FDA Form 1572 is comprised of several key components that are critical for its completion. Investigators must provide detailed information about their qualifications and commitments to conducting the clinical study. Each section of the form, such as the investigator’s information and protocol details, is designed to ensure a comprehensive overview of the study requirements.
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Investigator's qualifications.
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Protocol information.
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Commitments and responsibilities outlined clearly.
Who Needs to Complete the FDA Form 1572 Statement of Investigator?
The target audience for the FDA Form 1572 primarily includes clinical investigators. Individuals who qualify must possess the appropriate expertise to conduct clinical trials. Additionally, candidates must meet specific prerequisites to ensure they are capable of adhering to the essential guidelines that accompany the form.
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Clinical investigators must possess adequate qualifications and training.
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Participants must adhere to ethical standards for conducting clinical studies.
How to Fill Out the FDA Form 1572 Statement of Investigator Online (Step-by-Step)
Filling out the FDA Form 1572 digitally using pdfFiller is straightforward. Here is a step-by-step process to assist investigators in completing the form online:
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Access the pdfFiller platform and locate the FDA Form 1572.
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Fill in all required fields, ensuring accuracy.
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Review documents for any common mistakes.
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Verify all data for compliance before submission.
How to Sign and Submit the FDA Form 1572 Statement of Investigator
Submitting the FDA Form 1572 involves considerations regarding signature types. Investigators can choose between digital signatures and wet signatures, each having specific requirements. Furthermore, it’s essential to understand the various submission methods available to ensure the form is properly sent to sponsors.
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Digital signatures offer convenience and efficiency.
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Wet signatures may be required in certain situations.
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Submission can be done electronically or via physical mail.
Consequences of Not Filing or Late Filing the FDA Form 1572 Statement of Investigator
Failing to file or submitting the FDA Form 1572 late can lead to significant legal implications. Delays in filing this essential document could stall clinical trials, causing financial and reputational harm. Adhering strictly to deadlines is crucial in maintaining compliance throughout the clinical investigation process.
Security and Compliance for the FDA Form 1572 Statement of Investigator
Security is a paramount concern when managing sensitive documents such as the FDA Form 1572. Utilizing pdfFiller ensures compliance with various regulations, including HIPAA and GDPR, protecting the privacy and data of investigators and their participants. Implementing robust security measures safeguards personal information throughout the filing process.
How pdfFiller Can Help with the FDA Form 1572 Statement of Investigator
pdfFiller provides various advantages in completing the FDA Form 1572, including powerful features for form creation and electronic signing. Investigators will find that the platform is user-friendly and enables cloud accessibility, catering to busy professionals needing to manage documentation efficiently.
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Create and manage fillable forms effortlessly.
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Utilize eSigning capabilities for quick approvals.
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Share documents securely with all stakeholders.
Next Steps: Begin Your FDA Form 1572 Statement of Investigator Process
To get started with the FDA Form 1572, access the pdfFiller platform today. Users can take advantage of additional resources and support offered through pdfFiller to facilitate their clinical trial submission process.
How to fill out the FDA 1572
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1.Access and open the FDA Form 1572 on pdfFiller by searching for the form title in the platform search bar.
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2.Use the pdfFiller interface to navigate the form. Familiarize yourself with the layout and available tools such as text boxes and checkboxes.
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3.Gather all necessary information required to complete the form, including your education, experience, and commitment details about the clinical study.
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4.Begin filling in the form by clicking on each blank field. Enter relevant information about your qualifications and the clinical protocol as specified.
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5.If additional information is needed, utilize the 'Add Note' feature to provide clarification on any fields.
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6.Ensure to confirm that all sections of the form are complete and accurate before proceeding to the next steps.
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7.Review the form carefully, checking for any errors or omissions. Ensure that you have signed and dated the form as required.
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8.Once the form is finalized, save your changes. You can download it in various formats or submit it directly through pdfFiller if that option is available.
Who is eligible to complete the FDA Form 1572?
The FDA Form 1572 is specifically designed for clinical investigators involved in drug trials. It is essential that only qualified individuals with the necessary education and experience complete this form.
What are the most common mistakes to avoid when filling out this form?
Common mistakes include leaving blank fields, not signing and dating the form, and failed to provide complete information about qualifications and commitments. Always review your entries before submitting.
How is the FDA Form 1572 submitted?
The completed FDA Form 1572 should be submitted to the sponsor of the clinical trial for inclusion in the Investigational New Drug Application (IND). Ensure all sections are properly completed prior to submission.
Are there any specific deadlines associated with this form?
While the form itself doesn't have a submission deadline, it should be completed and submitted as part of the IND process, which typically has time-sensitive requirements. Check with your sponsor for specific timelines.
What supporting documents are needed when submitting the FDA Form 1572?
Along with the FDA Form 1572, you may need to provide additional documentation, such as your CV, proof of qualifications, and any relevant agreements related to the clinical study.
How long does it take to process the FDA Form 1572?
Processing times for the FDA Form 1572 can vary. It often depends on the IND submission timeline. Typically, the evaluation may take several weeks but this varies from case to case.
Can I make changes to the FDA Form 1572 after submitting it?
Changes to the FDA Form 1572 after submission may require an amendment, which should be discussed with the sponsor. Ensure accuracy before submission to minimize the need for changes.
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