| Objcetive:this paper analyzes the "acupuncture and clomiphene vlive birth rate for women with polycystic ovary syndrome:a randomized controlled trail of international cooperation" Project data analysis of the integrated managemen Mainly from the project before the implementation of data management The data management in the process of project implementation and Project data management in the late to Explore the new idea of the construction of large-scale clinical trial data management of traditional Chinese medicine To provide the reference for the research of other RCT。Methods:According to the order The prophase project In the process of project implementation Project implementation period The comprehensive analysis of the data management,To sum upResult:1.Data management of the project developed The data management plan from the beginningThe data management plan and standard operating procedure from the beginning.2.The whole process of project implementation pay attention to the cultivation of the talent,This is not only reflected in the data management personnel to get a better learning and training,but also pay attention to the first base for patients with data and research assistant training.3.Take in the process of project implementation level 4 system and international joint stage inspection system,More to make sure that the real project data reliability,Project results can better be international recognised and accepted.4.Project data cleanup gradually formed a unique set of standardized operation process,Ensure the effectiveness and the accuracy of the project data.Conclusion:Standardized high-quality PCOSAct project data management process1.PCOSAct project data before access to set up a special regulator and supervise regulate the whole data collection process;Professional high data collection tool is designed;Set up data management office,The whole process of online monitoring the project data quality;For the unified training data collectors,In strict accordance with the project plan,Make the data obtained from the authenticity and reliability,The clinical trial results have persuasive.2.PCOSAct project data using the level 4 field monitoring system and remote supervision way is effective,Can early find and solve problems,To reduce a large amount of data cleaning work late.3.PCOSAct project data in the process of management to cultivate a batch of professional data management specialist,The data management specialist By research base sent to the first-class university in the world and the management team study on data management,Rich experience in data management,for the base after clinical trial provides data management technology,To promote the clinical research of traditional Chinese medicine of high quality output.4.The overall quality of the PCOSAct project data is higher,But in the data cleaning work、Found that the quality of the database entry also needs to be improved,the content of baseline part and the end of treatment part is more and multifarious,Especially the two parts inventory entry need research assistant to check carefully,Had better use double double entry mode.5.In the old and new experiment sub-center of data management,Old sub-center of data management quality is slightly better than a new branch,This is mainly the old sub-center learn standardized operation training is more,The understanding of clinical scientific research data management degree is higher,So the experiments of RCT should to strengthen the standardization of new branch training and supervision work in the future.6.Pay attention to the importance of research assistant in the process of clinical research.The sub-center of data quality is a bit poor,Analysis of the main reasons for research assistant change more frequently.A high error rate is also in the transition period of research assistant,So in the later RCT test best cultivate a group of professional clinical researcher,This can better guarantee the quality of clinical trials of traditional Chinese medicine. |
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