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以FDA 1572表格填寫為例：理解FAQ和Health Authority (HA) 指南的使用

在執行臨床試驗的過程中，我們經常需要涉略其他國家的送審，尤其是美國食品和藥物管理局（US-FDA）。為了符合監管要求，我們需要即時完成相關文件，然而在許多情況下，我們可能對其中的表格或文件的填寫方式和相關規範不夠熟悉。以FDA的1572表格為例，這是一份我們雖然非常熟悉，但在填寫和理解方面仍感困惑的表格。

為了協助大家更好地理解和應對填寫相關文件的問題，FDA提供了針對FDA 1572表格的常見問題解答（FAQ）指南。儘管這份指南最早於2010年就已存在，但在2021年進行了一系列的修訂，包含一些建議的修改。這份指南對於填寫FDA 1572表格提供了實用的指導，同時也涵蓋了各種可能的疑問和困惑。

最新的FAQ指南主要針對FDA 1572表格進行了一系列的修訂，其中包括簽名要求豁免的解釋，以及新增了一個關於表格簽名豁免流程的全新部分，概述了在研究者無法或不願意簽署表格的情況下，向FDA提交簽名豁免請求的流程。同時，該指南強調了評論提交的期限，鼓勵各方提出意見和建議，以確保最終版本的制定能夠充分考慮相關意見。

除了涉及表格的具體填寫事宜外，指南還將重心擴展至機密信息的處理，強調了對機密信息的正確標記和識別，同時規定了相應的審查和披露程序。最終，指南強調了這份草案指南將與FDA 1572指南整合在一起，形成一份全面的指南，為相關利益相關方提供更完整的參考資源。

與FDA類似，其他國家的健康機構（HA）也提供了關於臨床研究的FAQ。例如，日本的PMDA（醫療產品及生命科學產品的審評及監管機構）和FDA一樣，提供了關於臨床研究的常見問題解答，供學員參考。

在研究者面對填寫FDA 1572表格或其他相關文件時，了解這些FAQ指南對於解決疑問和確保合規性至關重要。通過仔細閱讀並參考這些指南，學員們能夠更加自信地處理各類文件工作，確保其參與的臨床研究符合國際和本國的監管要求。

https://www.fda.gov/media/148810/download

(Frequently Asked Questions Statement of Investigator (Form FDA 1572)2021 revision)

https://www.fda.gov/media/78830/download

(Frequently Asked Questions Statement of Investigator (Form FDA 1572) 2010 version)

Other HA FAQ:

Understanding FDA Form 1572: FAQs and Guidance from Global Health Authorities (HA)

In the process of conducting clinical trials, navigating submissions to regulatory authorities, particularly the US-FDA, is often necessary. To comply with regulatory requirements, it is essential to prepare and complete relevant documents promptly. However, in many cases, we may not fully understand how to fill out specific forms or the associated regulations. Take the FDA (U.S. Food and Drug Administration) Form 1572, for example; it is a form we are familiar with, yet its intricacies may elude us. To assist in better understanding and addressing issues related to filling out relevant documents, the FDA FAQs provide a guide concerning the FDA 1572 form. Although this guide has been in existence since 2010, it underwent some suggested revisions in 2021. This article will provide a link for reference.

Introduction to FDA Form 1572

Form FDA 1572, titled “Statement of Investigator,” is a document that must be completed by the principal investigator (researcher) in clinical studies. This form includes personal information, qualifications, and the investigator’s commitment to compliance with FDA regulations. The latest release of the FAQ guide aims to help sponsors, clinical investigators, and Institutional Review Boards (IRBs) better understand and apply the FDA 1572 form.

Highlights of the FAQ Guide

Form FAQ Revisions

The newly released FAQ guide introduces revisions to common questions about the FDA 1572 form, including an explanation of the waiver process for the signature requirement. This is a crucial issue for investigators who, for various reasons, cannot sign the form, and the guide provides detailed answers to this question.

Signature Waiver Process

The guide introduces a brand-new section titled “Section #9: FDA 1572 Form Signature Waiver.” This section outlines the process for submitting requests to FDA for waivers from the signature requirements when investigators cannot or are unwilling to sign the form for clinical studies conducted abroad under an Investigational New Drug (IND) application.

Comment Submission Deadline

FDA encourages stakeholders to provide comments and suggestions on the guide before the deadline to ensure that relevant feedback is considered before the final version is drafted. Comments can be submitted electronically or in writing, with detailed submission instructions provided in the guide.

Handling Confidential Information

For comments containing confidential information, FDA provides detailed submission instructions, emphasizing the correct marking and identification of confidential information and outlining the review and disclosure procedures for such information.

Integration of the Guide

The guide emphasizes that this draft guide is not intended to exist independently but will be integrated with the FDA 1572 guidance to form a comprehensive guide. This will provide a more complete reference resource for stakeholders involved.

International Reference: Other HA FAQs

Similar to the FDA, other countries’ Health Authorities (HAs) also provide FAQs on clinical research. For example, Japan’s PMDA (Pharmaceuticals and Medical Devices Agency), like the FDA, offers FAQs on clinical research for participants to reference.

When researchers face challenges in filling out forms like FDA 1572 or other relevant documents, understanding these FAQ guides is crucial for resolving queries and ensuring compliance. By carefully reading and referencing these guides, participants can confidently handle various document-related tasks, ensuring their involvement in clinical research aligns with both international and domestic regulatory requirements.