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FDA Clinical Investigator Administrative Actions - Disqualification Institutional Review Boards, Clinical Investigators, and Sponsors

蒋千琴 12/8/2021 浏览 154 FDA U.S

标准简介

Clinical Investigator Administrative Actions - Disqualification Institutional Review Boards, Clinical Investigators, and Sponsors[附网盘链接]是Food And Drug Administration于不久之前发布的FDA标准，适用于U.S。

标准截图

Clinical Investigator Administrative Actions - Disqualification Institutional Review Boards, Clinical Investigators, and Sponsors[附网盘链接]
Clinical Investigator Administrative Actions - Disqualification Institutional Review Boards, Clinical Investigators, and Sponsors[附网盘链接](截图)

 

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标准文档类型为Clinical Investigator Administrative Actions - Disqualification Institutional Review Boards, Clinical Investigators, and Sponsors[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

Information Sheet Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors Clinical Investigator Administrative Actions – Disqualification This guidance represents the Food and Drug Administration’s (FDA’s) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the appropriate FDA staff. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance. I. INTRODUCTION This Guidance document is intended to inform institutional review boards (IRBs), clinical investigators, and sponsors about the administrative action of disqualifying a clinical investigator from participating in studies involving investigational new drugs (including 1

biologics) or devices. FDA may disqualify a clinical investigator from receiving investigational drugs (including biologics) and devices if FDA determines that the investigator has repeatedly or deliberately violated the agency’s regulations, or has repeatedly or deliberately submitted false information to the sponsor or FDA in any 2 required report. FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidance documents describe the FDA’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA’s guidance documents means that something is suggested or recommended, but not required. 1

This guidance document was prepared primarily to address issues related to FDA-regulated research involving human subjects; however, disqualification actions may also be initiated for investigators who conduct studies in support of Investigational New Animal Drug Applications (INAD) or New Animal Drug Applications (NADA) under 21 CFR 511.1. 2

See 21 CFR 312.70 and 812.119. Disqualification of clinical investigators conducting studies to support INADs or NADAs is authorized in 21 CFR 511.1(c).

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