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目的:作为“十一五”白血病课题组监查员,在2年课题具体实施基础上,总结难治性急性白血病围化疗期中医干预治疗方案监查管理要点、发现的问题及其解决对策。方法:在临床研究具体实施中总结难治性急性白血病课题临床实施中监查管理要点、发现的问题及其解决。结果:本课题先后接受科技部稽查1次,第三方质控小组联合稽查与监查两次,作为本课题的二级监查员,在课题负责人的指导下,先后独立负责对6个中心累计进行11次实地监查与培训,深刻体会到监查与培训是课题科学管理的重要组成部分,其中监查是质控的中心环节,培训是质控的基础,分中心质控员是研究的基层核心,是质控最基础也是最重要的环节。结论:监查是质控的中心环节,分中心质控员是质控最基础也是最重要的环节。
Objective: As the “Eleventh Five-Year” Leukemia Task Force Inspectors, based on the implementation of the 2-year project, summarize the key points of supervision and management of traditional Chinese medicine intervention program in the treatment of refractory acute leukemia, found problems and solutions Countermeasures. Methods: To summarize the key points of supervision and management in the clinical implementation of refractory acute leukemia in clinical practice and find the problems and solutions. Results: The subject has been inspected by the Ministry of Science and Technology one time, the third-party quality control team jointly audited and audited twice, as the subject of the second-level auditors, under the guidance of the project leader, has been independently responsible for the six centers A total of 11 field audits and trainings were carried out. We realized that auditing and training are an important part of the scientific management of the subject. Monitoring is the central aspect of quality control. Training is the basis of quality control. The grass-roots core is the most basic quality control is the most important part. Conclusion: Audit is the central part of quality control. Quality control is the basic and most important part of quality control.