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Practical Issues in Clinical Inspection Process

  • Regulatory Science: Original Article
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Abstract

Regulatory inspection of clinical trial is necessary in order for (1) assessing compliance with statutory requirements and regulatory requirement governing the conduct of clinical trials and (2) verifying the accuracy and reliability of clinical trial data submitted to regulatory agencies such as the United States Food and Drug Administration (FDA) in support of research or marketing applications. This article provides an overview of clinical inspection process and issues that are commonly encountered during the conduct of clinical trials. In addition, a couple of sampling plans for clinical inspection of relatively large trials are proposed. The proposed statistical process for clinical inspection that will achieve a desired degree of inspection accuracy and reliability is useful when the resources of inspectors are limited. The proposed 2-stage sampling plan can be applied to clinical inspection for multicenter and/or multinational multicenter clinical trials.

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Authors and Affiliations

  1. Center for Food and Drug Inspection, China Food and Drug Administration, Beijing, China

    Fuyu Song MS, Xue Qian & Jianming Li MD

  2. Duke University School of Medicine, Durham, NC, USA

    Shein-Chung Chow PhD

  3. Sun Yat-sen University Cancer Centre, 651 Dongfengdong Road, Guangzhou, China

    Minghuang Hong MD

Authors
  1. Fuyu Song MS
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  2. Xue Qian
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  3. Jianming Li MD
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  4. Shein-Chung Chow PhD
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  5. Minghuang Hong MD
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Corresponding author

Correspondence to Minghuang Hong MD.

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Cite this article

Song, F., Qian, X., Li, J. et al. Practical Issues in Clinical Inspection Process. Ther Innov Regul Sci 53, 374–380 (2019). https://doi.org/10.1177/2168479018769887

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  • DOI: https://doi.org/10.1177/2168479018769887

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