Quality Risk Management of the Changes of Sponsors and Production Sites of Drug Clinical Trial - Taking FDA’s Management as Reference

Abstract

Objective To explore the risk management of the changes of sponsors and/or production sites during drug clinical trials based on the theories of quality management, risk management, and change management. Methods The method of failure modes and effect analysis (FMEA) was used to identify risks through literature research, expert consultation, comparative research, and comprehensive analysis. Besides, risk priority number (RPN) was used to evaluate the risks. Results and Conclusion A FMEA of the changes of sponsors and/or production sites in clinical trials was constructed and RPN values of every failure mode and causes were obtained. Based on the RPN values, the core risk control points for different combination modes of sponsors and/or production sites after their changes were identified. It is recommended that China should strengthen the construction of the sponsor responsibility system. In addition, the changes of sponsors and/or production sites during the clinical trial period should be allowed in an orderly manner under the premise of ensuring the quality of clinical trials and subject protection.

Keywords

sponsor / production site / quality management / risk management / change management / drug clinical trials

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