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| Construction of the standardization for drug clinical trials of quality based on network |
| Hits 1464 Download times 1124 Received:February 16, 2017 |
| View Full Text View/Add Comment Download reader |
| DOI
10.11656/j.issn.1672-1519.2017.06.10 |
| Key Words
drug clinical trial;centralized quality control;standardization construction |
| Author Name | Affiliation | | CAO Hong-bo | 1. Institute of Traditional Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China
2. Tianjin Institute of Traditional Chinese Medicine Clinical Evaluation, Tianjin 300193, China | | ZHANG Jun-hua | 1. Institute of Traditional Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China
2. Tianjin Institute of Traditional Chinese Medicine Clinical Evaluation, Tianjin 300193, China | | ZHAI Jing-bo | 1. Institute of Traditional Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China
2. Tianjin Institute of Traditional Chinese Medicine Clinical Evaluation, Tianjin 300193, China | | LIU Zhi | 1. Institute of Traditional Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China
2. Tianjin Institute of Traditional Chinese Medicine Clinical Evaluation, Tianjin 300193, China |
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| Abstract
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| Quality control is a key link in the process of clinical trials and important content, the quality of clinical trials about the reliability of test results. Therefore, clinical researchers devoted to study how to strengthen the quality control of drug clinical trials. As the electronic data and remote mode in recent years in the application and development of clinical trial data management, establishing the new clinical trials quality control system is imminent. Based on previous research experience, this paper puts forward the concept of quality of centralized control, which is based on network technology, the realization of drug clinical trials main links and personnel online interaction, through the role assignment and responsibility, realize the dynamic quality control. Centralized drug clinical trial the fundamental lies in the standardization for the implementation of quality control, including the seamless network supervision and clinical design is the key. In this paper, regarding the centralized modern drug clinical trials quality control paper introduced standardized specifications and requirements of the construction of the peer to reference. |
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