FDA A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers Draft

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A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers Draft[附网盘链接]是Food And Drug Administration于之前发布的FDA标准，适用于US。

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Draft — Not for Implementation 1 A Risk-Based Approach to Monitoring of Clinical Investigations 2 Questions and Answers 1

3 Guidance for Industry 4 5 6 This draft guidance, when finalized, will represent the current thinking of the Food and Drug 7 Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not 8 binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the 9 applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible 10 for this guidance as listed on the title page. 11 12 13 14 15 I. INTRODUCTION 16 17 This document provides guidance on risk-based approaches to monitoring investigational studies 18 of human drug and biological products, medical devices, and combinations thereof. This 19 guidance contains recommendations on planning a monitoring approach, developing the content 20 of a monitoring plan, and addressing and communicating monitoring results. This guidance 21 expands on the guidance for industry Oversight of Clinical Investigations – A Risk-Based 2

22 Approach to Monitoring (August 2013) (the RBM guidance) by providing additional guidance 23 to facilitate sponsors’ implementation of risk-based monitoring. 24 25 In general, FDA’s guidance documents do not establish legally enforceable responsibilities. 26 Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only 27 as recommendations, unless specific regulatory or statutory requirements are cited. The use of 28 the word should in Agency guidances means that something is suggested or recommended, but 29 not required. 30 31 32 II. BACKGROUND 33 34 Sponsors of clinical investigations involving human drugs, biological products, medical devices, 35 and combinations thereof are required to provide oversight to ensure adequate protection of the 3

36 rights, welfare, and safety of human subjects and the quality of the data submitted to FDA. 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, the Center for Devices and Radiological Health, the Office of Good Clinical Practice, and the Office of Regulatory Affairs 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. 3

21 CFR part 312, subpart D generally (Responsibilities of Sponsors and Investigators) and 21 CFR part 812, subpart C generally (Responsibilities of Sponsors).

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