| Objective:This paper analyzes the "Acupuncture and clomiphene live birth rate for women with polycystic ovary syndrome:a randomized controlled trial of international cooperation"(referred PCOSAct project)1000 integrated management subjects blood samples and explore its 21 points Center(25)actual management of blood samples to evaluate the quality of each sub-center management,office management deficiencies summarized in order to provide a reliable basis for the establishment of future testing and biobanking real test data.Methods:1.By PCOSAct project all subjects blood samples collected by centrifugation,marking,storage,cold chain transport,central laboratory receiving,storage,sample registration and inspection of all aspects of quality management,the formation of someone special management system,the test manage blood sample into a clinical trial quality control system while establishing clinical electronic biobank.2.From the blood sample standard management processes,research assistant in the management,analysis of blood samples of 21 PCOSAct project sub-centers(25 hospitals)subjects shedding quality management,central laboratory management.1)Analysis of blood samples of blood flow to develop standardized,develop uniform training standards,under emergency conditions to solve the problem of preservation of blood samples.2)Replace the impact analysis study of blood samples assistant management.3)analyze the impact during the test subjects,such as shedding of blood samples collected.The result:1.PCOSAct project from the first subjects July 6,2012 to begin treatment until February 2015 the 1000 subjects the end of treatment,testing of all blood samples have been transported back to the Central Laboratory of Heilongjiang University of Chinese Medicine,in line with test standards,the management of the various stages in order.2.There are 1000 cases during the study subjects involved in the treatment,which is not the subject off 76 people,including 67 subjects for different reasons and at the end of the trial shed blood samples collected after treatment did not.Conclusion:a central laboratory someone special responsibility in favor of the development of the blood samples of the management team,to the establishment of Biobank,which provides true and reliable basis for post-data detection.3.The management of the overall better blood samples,sample collection,storage,labeling,cold chain logistics company specializing in transportation,transported back to the sample quality are manageable,less hemolysis sample.4.The reason is not blood samples collected mainly in the screening or treatment of a subject during shedding.5.The sub-standard training center’s research assistant,meticulous division of labor,clear responsibilities of beneficial integrated management of blood samples. |