The importance of the appropriate sample management in regulated bioanalyses is undeniable for clinical and non-clinical study support due to the fact that if samples are compromised at any stage prior to the analysis, the study results may be affected. Therefore, one of the necessary elements of clinical trials (CT) planning following the concept of quality-by-design is the conduct of risk assessment using specific tools, such as risk assessment methods. The purpose of this paper is to analyze the most general concepts of risk assessment and to select the most optimal method for quality management of CT data. The methodological basis of the study is WHO regulation and research papers on risk management. A comparative analysis of the main risk assessment methods has been conducted. Our preference is given to the hazard analysis and critical control points (HACCP) method, a systematic preventive method for CT data quality assurance. The results of the comparison have identified the advantages and disadvantages of the most popular methods of risk assessment and the opportunities of using HACCP systems for quality assurance. Unlike most risk assessment methods, the HACCP methodology uses proactive measures instead of corrective actions, so it is appropriate to use at the clinical trial site.

中文翻译：

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HACCP 作为确保生物样品质量的风险管理工具

在受监管的生物分析中，适当的样品管理对于临床和非临床研究支持的重要性是不可否认的，因为如果样品在分析之前的任何阶段受到损害，研究结果可能会受到影响。因此，遵循设计质量概念的临床试验 (CT) 规划的必要要素之一是使用特定工具（例如风险评估方法）进行风险评估。本文的目的是分析风险评估的最一般概念，并选择最优化的 CT 数据质量管理方法。该研究的方法论基础是世卫组织关于风险管理的监管和研究论文。对主要风险评估方法进行了比较分析。我们首选危害分析和关键控制点 (HACCP) 方法，这是一种用于 CT 数据质量保证的系统性预防方法。比较结果确定了最流行的风险评估方法的优缺点以及使用 HACCP 系统进行质量保证的机会。与大多数风险评估方法不同，HACCP 方法使用主动措施而不是纠正措施，因此适合在临床试验现场使用。