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Implementation and management of drug clinical trials during the period of COVID-19 epidemic
Chinese Journal of New Drugs ; 31(10):972-977, 2022.
Article in Chinese | EMBASE | ID: covidwho-1894105
ABSTRACT

Objective:

To explore the implementation and management measures of drug clinical trials during the period of COVID-19 epidemic, protect the safety and rights of subjects, ensure the smooth implementation of clinical trials, and provide reference and suggestions for the management work of clinical trial institutions.

Methods:

According to the requirements of COVID-19 epidemic prevention and control policies and the national guiding principles for drug clinical trial management, combining the experience of our hospital, we optimized the working process and proposed management measures in four aspects including project and personnel management, subject follow-up management, drug distribution management, and communication between all parties involved in clinical trials. Results and

conclusions:

During the period of COVID-19 epidemic, our hospital has taken a series of measures which ensured the smooth implementation of more than 200 drug clinical trials and protected the safety and rights of subjects and researchers.
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Collection: Databases of international organizations Database: EMBASE Type of study: Randomized controlled trials Language: Chinese Journal: Chinese Journal of New Drugs Year: 2022 Document Type: Article

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Collection: Databases of international organizations Database: EMBASE Type of study: Randomized controlled trials Language: Chinese Journal: Chinese Journal of New Drugs Year: 2022 Document Type: Article