| Objective:Complying with the requirements of clinical trial transparency and analyzing the transparency status and quality management system of PCOSAct project,to evaluating the safety and quality of PCOSAct project management,identifying deficiencies,to provide an objective basis for the latter management plans and reference for the other similar RCT research in future.Method:1.Complying with the requirements of transparency in clinical trials,summarizing the transparency measures and quality management system of PCOSAct project from the planning stage,the implementation stage,to the monitoring stages;based on the basis of the existing management methods,the PDCA cycle method was proposed to strengthen quality control and management.2.Evaluated the management quality of PCOSAct project by analyzing the reports of the dropout cases,the deviation report tables and the checking results of the eCRF database.① Analyzing the reports of the dropout cases and making statistics on the dropout rate and the count of dropout occurred on each stage,to find the stage during which the dropout occurred more frequency.②Analyzing the deviation report tables,and checking the date of events occurrence and reported date,to make statistic on the number of reports that weren’t reported timely according to the requirement for reporting time in standard operating procedures;and analyzing the deviates type of the reported events,found out the events caused by investigator factors.Also,evaluated the management quality of the project by comparing the number among 3 stages/group,between 2 teams ③Analyzing the checking results of the eCRF database during this study period,making the statistic on the number of erroneous items,to compare the database input quality of each sub-centers;classifying the erroneous items into four types:the unit error,time entry errors,numerical input errors,omissions or excess input,found out the Error-prone step for eCRF entry to provided precautions for research assistants.Result:1.The PCOSAct project complied with the requirements of transparency.The management of the project was systematic.2.Subject dropout rate of PCOSAct project was 4.89%during the study period lower than the planning 20%when calculated sample size;81.81 percent of dropout cases happened before the third treatment cycle.3.212 cases of deviation were happened during the whole study stage,and 83%wasn’t reported in time.There were no difference among the 3 groups during the three stages;the rate of deviation event not reported in time in the old center was higher than the new center,P<0.05;stage comparison,that of the old center in stage 3 was higher than in the new center,P<0.05,no difference in the remaining two stage;for new center,that in stage 1 was higher than in stage 2 and 3,and there was no difference between stage 2 and stage3,P>0.05.There was no difference among at all stages for that of old center.4.During the whole study stage,the number of deviation caused by the investigator factors was decreased.That in group 2 was higher than group 3,P<0.05,there were no differences between group 1 and Group 2,so were in Group 1 and Group 3;that in Group 2 was higher than in Group3 during stage 1;in Group 1 that was higher than in Group 2 during stage 2.During the whole study stage,the difference of deviation event rate caused by the investigator factors between old and new sub-centers was not statistically significant,P>0.05.That of the old center was higher than in the new Group during stage 1,P<0.05;the difference of that was not significant during stagel,P>0.05;compare the various stages of the new center,the difference was not significant,P>0.05;for old center Group that is higher during stage 1 than in stage 2 and stage 3.5.There were 429 input item found in eCRF database.Distribution composition:baseline problem entries 84.15%,treatment entry-6.06%,after treatment-9.79%.Types of erroneous items composition:the unit error-21.45%,time entry errors-69.00%,numerical input errors-4.66%,omissions or excess input-4.90%.17,21,20 centers generated more input entry errors;11,12,10 generated fewer input entry errors.Conclusions:1.PDCA cycle method can be used for strengthening clinical trial quality management is also suitable for.2.The quality of subject management was high,and the dropout rate was lower.3.The phenomenon of that deviation events weren’t reported in time was common,and three management groups did not improve after the two major monitor;new center group research assistant reported the deviation more timely.4.The research quality of was improved,and he rate of deviation caused by investigator was decreased.The research quality of Groupl was stable,deviation rate is lower.That of Group 2 and Group 3 was improved after two surveillances.The research quality of new center group was more stable throughout the study period and the old one had been effectively improved after the first surveillance.5.The baseline entry of eCRF table should be noted and with particular attention to the time format and units. |
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