在中国开展国际合作学术性临床研究项目的质量管理思考

Reflection of quality management of conducting international cooperative academic clini- cal research in China

目的通过总结北京大学医学部资助国际合作学术性临床研究的监查／稽查发现常见问题，分析我国目前开展国际合作学术性临床研究面临的主要挑战，从而提出相关建议和措施以改善研究质量。方法对北京大学医学部资助国际合作学术性临床研究的项目管理存档资料进行整理，按照监查／稽查发现常见问题进行描述性分析。结果20112016年北京大学医学部资助的14项国际合作学术性临床研究，监查／稽查发现的常见问题为研究文件不规范（100．0％）、伦理规范问题（71．4％）、方案不依从（64．3％）、数据质量问题（71．4％）、合作双方沟通问题（14．3％）、生物样本出口问题（14．3％）、人组进度延迟（14．3％）、项目提前中止（7．1％）。结论只有符合国家法规并在国家的大力支持前提下，制定符合中国实际要求的临床研究方案、标准操作规程（SOP）以及建立研究质量管理体系，研究人员严格、规范地按照SOP以及相关法规开展研究。才能获取可信可靠的数据，保证研究的质量，得出同行认同的研究结论，准确地回答科学问题。

Objective Through summarizing quality management practices of international coop erative academic clinical studies funded by Peking University Health Science Center, analyzing its present major challenges of implementation in China, this paper proposed related measurements and suggestions to improve the quality of clinical research. Methods To sort the proiect management ar- chive data, as well as descriptive analysis of the common monitoring/auditing findings. Results From the year 2011 to 2016, there were 14 such studies funded by Peking University health science center, common findings during monitoring and or auditing were classified as following categories, study files problem （100.0%）, ethics problem （71.4%）, protocol noncompliance （64.3%）, data quality issues （71. 4%）, communication problem in study teams （14. 3%）, export problems of bio-specimens （14.3%）, recruiting delay （14.3%） and cooperation termination in advance （7.1%）. Conclusions In order to obtain credible and reliable data, peer recognized research conclusion and accurate answered scientific questions, it is essential for investigators to comply with laws and regulations and being strongly supported. Furthermore, researchers also need to establish and strictly follow study proto cols, standard operating procedures （SOPs）, research quality management system and relevant nation al laws and regulations that are comply with actual requirements in China.