FDA 1572 Form Completion Instructions Guide
This document provides detailed instructions for completing Form FDA 1572, essential for clinical investigators working under an IND. It includes a step-by-step guide for filling out the form and key information on compliance requirements. Understanding this guide is crucial for ensuring successful submissions and adherence to FDA regulations.
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How do I fill this out?
To fill out the Form FDA 1572, begin by gathering the required information about the investigator and clinical site. Next, ensure all relevant qualifications and training details are accurately documented. Finally, review the commitments and ensure everything aligns with FDA regulations.
How to fill out the FDA 1572 Form Completion Instructions Guide?
1
Gather the investigator's information and qualifications.
2
Enter details of the clinical sites and laboratories involved.
3
List sub-investigators and their roles clearly.
4
Provide comprehensive protocol information.
5
Sign the form to confirm adherence to the protocol and regulations.
Who needs the FDA 1572 Form Completion Instructions Guide?
1
Clinical investigators conducting studies under an IND.
2
Research coordinators managing the investigation team.
3
Pharmaceutical sponsors needing documentation of investigator qualifications.
4
Regulatory affairs professionals overseeing FDA compliance.
5
Institutional review boards (IRBs) requiring detailed study reports.
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What are the instructions for submitting this form?
Submit Form FDA 1572 via email to osro-submissions@nih.gov. Alternatively, you may fax it to (301) 480-1263, or submit it online through the NIH electronic submission system. For physical submissions, send to the NIH Office of Sponsor and Regulatory Oversight in Bethesda, MD. Ensure that the form is completed in full, accurate and attached with all necessary documents for the review process to begin. To ensure prompt processing of your submission, adhere to indicated deadlines and guidelines.
What are the important dates for this form in 2024 and 2025?
In 2024, ensure that any submissions using Form FDA 1572 are completed by the latest updates, with reminders for filing deadlines set throughout the year. In 2025, expect continued updates and revisions, focusing on regulatory compliance and investigator obligations. Staying informed of these dates is crucial for maintaining eligibility and support during your clinical investigations.
What is the purpose of this form?
The purpose of Form FDA 1572 is to document the qualifications of investigators and the clinical site for studies involving investigational drugs and biologics. It serves as a contractual agreement between the investigator and the sponsor, outlining the responsibilities under FDA regulations. By completing this form accurately, investigators help ensure compliance with safety, rights, and welfare standards for participants.
Tell me about this form and its components and fields line-by-line.
- 1. NAME AND ADDRESS OF INVESTIGATOR: This field captures the full legal name and contact address for the investigator.
- 2. EDUCATION, TRAINING, AND EXPERIENCE: Details the qualifications and professional background of the investigator.
- 3. NAME AND ADDRESS OF MEDICAL FACILITY: Lists the institutions where the clinical investigations will take place.
- 4. CLINICAL LABORATORY FACILITIES: Identifies any labs used for conducting tests associated with the study.
- 5. INSTITUTIONAL REVIEW BOARD INFORMATION: Required details about the IRB responsible for the study approvals.
- 6. NAMES OF SUB-INVESTIGATORS: Names of individuals assisting the principal investigator in the study.
- 7. PROTOCOL INFORMATION: Details of the research protocol associated with the IND.
- 8. COMMITMENTS: The investigator's commitments regarding adherence to study protocols.
What happens if I fail to submit this form?
Failing to submit Form FDA 1572 can lead to the disqualification of an investigator from participating in the clinical study. Incomplete or incorrect forms may delay the approval process and jeopardize the integrity of the research. Therefore, ensuring timely and accurate submission is critical for compliance and successful study progression.
- Investigator Disqualification: If the form is not submitted, investigators may be barred from conducting the research.
- Protocol Delays: Ineffective submissions can stall the approval processes, affecting study timelines.
- Compliance Issues: Non-compliance with FDA regulations can lead to penalties for investigators and sponsors.
How do I know when to use this form?
- 1. New Protocol Submission: Required when adding new protocols to an existing IND.
- 2. Change in Principal Investigator: Necessary to document a change in the lead investigator.
- 3. Location Change: Required if the study is moved to a different clinical site.
- 4. Update to Study Team: Needed when new significant contributors join the research team.
- 5. Regular Updates: Important for maintaining compliance and updating participant information.
Frequently Asked Questions
What is Form FDA 1572?
Form FDA 1572 is a Statement of Investigator form required for research involving investigational new drugs.
Who needs to fill out Form FDA 1572?
Clinical investigators involved in studies conducted under an IND must complete this form.
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