Volume 19 Issue 8
Aug.  2021
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Article Navigation >  Chinese Journal of General Practice  > 2021  >  19(8): 1403-1407
ZENG Li-yan, WANG Qian, MENG Xian-min, KE Jing, DONG Hua-juan, LU Hong-zhou. Process management of biological samples in phase Ⅰ clinical trials[J]. Chinese Journal of General Practice, 2021, 19(8): 1403-1407. doi: 10.16766/j.cnki.issn.1674-4152.002071
Citation: ZENG Li-yan, WANG Qian, MENG Xian-min, KE Jing, DONG Hua-juan, LU Hong-zhou. Process management of biological samples in phase Ⅰ clinical trials[J]. Chinese Journal of General Practice, 2021, 19(8): 1403-1407. doi: 10.16766/j.cnki.issn.1674-4152.002071
shu

Process management of biological samples in phase Ⅰ clinical trials

doi: 10.16766/j.cnki.issn.1674-4152.002071

  • Clinical Research Center for Innovative Drugs, Shanghai Public Health Clinical Center, Shanghai 201500, China

Funds:

 2017ZX09304027

  • Received Date: 2020-09-14
    Available Online: 2022-02-16
    Abstract
  •   Objective  The quality of biological sample management in phase Ⅰ clinical trials directly affects the authenticity and accuracy of clinical trial results. In recent years, the management of biological samples has become one of the research issues of great concern in China and abroad. This study established a process management system for biological samples in phase Ⅰ clinical trials, aiming to improve the quality and efficiency of biological samples and provide a reference for standardising biological sample management in phase Ⅰ clinical trials.  Methods  The experience from the standardisation and information requirements of biological sample management was summarised, and the procedures that affect the quality of biological samples in phase Ⅰ clinical trials, including personnel, labelling, reception, transfer, processing, equipment, materials, standard operating procedure (SOP), document management and sample information management, were described.  Results  A set of standardised process management system of biological samples has been established relying on biological sample information management system, temperature intelligent monitoring and alarm management system, professional sample management personnel, complete system and SOP to improve the quality of sample management. By the end of December 2020, it has been inspected on site by the National Medical Products Administration for 42 times and the provincial Medical Products Administration for 5 times, and exempted for inspection for 29 times, covering more than 60 drugs, all of which have passed the inspection successfully.  Conclusion  High-quality clinical biological samples are one of the core factors for the reliability, completeness and scientificity of phase Ⅰ clinical research data and results. The establishment of a standardised process of sample management system can improve the research quality of drug clinical trials, effectively prevent or reduce the occurrence of problems such as sample transportation, sample processing, in-and-out storage and daily management during the process management of biological samples, and ensure the accuracy, comparability and repeatability of drug clinical trial results.

     

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