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FDA Draft Information Sheet Sponsors, Clinical Investigators, and IRBs FAQs Statement of Investigator (Form FDA 1572) (Revision 1)

蒋千琴 3/6/2022 浏览 269 FDA U.S

标准简介

Draft Information Sheet Sponsors, Clinical Investigators, and IRBs FAQs Statement of Investigator (Form FDA 1572) (Revision 1)[附网盘链接]是Food&Drug Administration发布的FDA标准，适用于U.S。

标准截图

Draft Information Sheet Sponsors, Clinical Investigators, and IRBs FAQs Statement of Investigator (Form FDA 1572) (Revision 1)[附网盘链接]
Draft Information Sheet Sponsors, Clinical Investigators, and IRBs FAQs Statement of Investigator (Form FDA 1572) (Revision 1)[附网盘链接](截图)

 

标准文档说明

标准文档类型为Draft Information Sheet Sponsors, Clinical Investigators, and IRBs FAQs Statement of Investigator (Form FDA 1572) (Revision 1)[附网盘链接]高清PDF版本（文字版），标准文档内可进行搜索，可以复制原文，可粘贴。

标准部分原文

Draft — Not for Implementation 1 Information Sheet Guidance 1

2 for Sponsors, Clinical Investigators, and IRBs 3 Frequently Asked Questions 4 Statement of Investigator (Form FDA 1572) (Revision 1) 5 6 7 8 This draft guidance, when finalized, will represent the current thinking of the Food and Drug 9 Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not 10 binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the 11 applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible 12 for this guidance as listed on the title page. 13 14 15 16 17 I. INTRODUCTION 18 19 This guidance is intended to assist sponsors, clinical investigators, and institutional review boards 20 (IRBs) involved in clinical investigations of investigational drugs and biological products. This 21 guidance applies to clinical investigations conducted under 21 CFR part 312 (investigational new 22 drug application (IND) regulations) and describes how to complete the Statement of Investigator 23 (Form FDA 1572). 24 25 26 II. BACKGROUND 27 28 FDA has received questions about Form FDA 1572. The most frequently asked questions 29 (FAQs) are answered in the information sheet guidance for sponsors, clinical investigators, and 2

30 IRBs Frequently Asked Questions—Statement of Investigator (Form FDA 1572) (May 2010) (the 31 Form FDA 1572 FAQ Guidance). 32 33 This guidance, when finalized, partially revises the Form FDA 1572 FAQ Guidance and answers 34 additional questions received by FDA. Questions not answered either in this guidance or in the 35 Form FDA 1572 FAQ Guidance may be submitted to druginfo@fda.hhs.gov. 36 37 This guidance has been developed in response to multiple inquiries regarding waivers of the 38 signature requirement on Form FDA 1572 and, when finalized, will explain FDA’s current 1

This guidance has been prepared by the Office of Medical Policy in the Center for Drug Evaluation and Research in cooperation with the Center for Biologics Evaluation and Research and the Office of Good Clinical Practice at the Food and Drug Administration. 2

We update guidances periodically. For the most recent version of a guidance, check the FDA guidance web page at https://www.fda.gov/RegulatoryInformation/Guidances/default.htm.

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