With worldwide improvements in the regulations of international and domestic clinical trial conductions, the quality of clinical trials and trial data management are receiving a great deal of attention. To ensure the quality of clinical trials, maintain business flexibilities and effectively utilize internal and external resources, the outsourcing model is used in the management of clinical data in operation of pharmaceutical companies. The essential criteria of a successful outsourcing mode in clinical trial are selection of qualified contract research organizations (CRO); establishment of appropriate outsourcing model, and generation of effective quality control systems to ensure the authenticity, integrity and accuracy of the clinical trial data.
Clinical Trials as Topic ; Data Collection ; methods ; Information Storage and Retrieval ; methods ; Outsourced Services ; Quality Control

With worldwide improvements in the regulations of international and domestic clinical trial conductions, the quality of clinical trials and trial data management are receiving a great deal of attention. To ensure the quality of clinical trials, maintain business flexibilities and effectively utilize internal and external resources, the outsourcing model is used in the management of clinical data in operation of pharmaceutical companies. The essential criteria of a successful outsourcing mode in clinical trial are selection of qualified contract research organizations (CRO); establishment of appropriate outsourcing model, and generation of effective quality control systems to ensure the authenticity, integrity and accuracy of the clinical trial data.

Objective The application of modern information technology to manage critical values of clinical examination,in order to improve the management level of patients safety and reduce the medical risk.Methods The critical values reminder in medical security alert system is developed and applied,the core module of the system are warning monitor of equipment record and SMS warning monitor of alerting in testing critical value.Results Through the application of system,the information of testing critical values are obtained duly,comprehensively and accurately,the notification time of clinical testing critical values are abbreviated,the notification scopes are spread and achieved the management of critical value at different levels.Conclusion The application of the system can be perfected the management of critical values,ensured patients safety,improved the medical quality and enhanced the management level of hospital,and then the system has become another example of informationization creating value.

Objects:To investigate the current situation of interpersonal communication inpreparatory students in one Xinjiang medical college from the exchanges between students.Methods:Using self-developed questionnaire,a survey was conducted among 200 preparatory students and depth interviews were conducted for typical cases.Results:Preppies showed a strong willing of interpersonal communication.In the process of students' interaction,some features were presented as followings:pure motives but dissimilarity,narrow range of interactions,lack of interaction ability and the single form of social activities.Conclusion:Based on the above current situation of interpersonal communication in preparatory students,it should enhance the language application ability of preparatory stage,change the idea and attach importance to the education of humanistic quality in preparatory education and train preppy's expression and listening art.

Objective To investigate the cognitive impairment of middle-aged patients with type 2 diabetes mellitus(T2DM). Methods Wechsler adult intelligence scale-Chinese revised edition (WATS-RC) was used as the tool to examine the cognitive function of middle-aged patients with T2DM and the healthy controls in 51 cases. The t-test was used to compare the differences in score between patients and the control group. The patients were divided into two groups with or without cognitive dysfunction. The logistic regression analysis was made for all the variables to confirm risk factors for the cognitive dysfunction in diabetes. Results The WAITS-RC scores of digit-symbol coding test and block design test were much lower(P<0.05) in diabetes versus control group. The other tests showed no significant difference. The cognitive function was negatively correlated with HbA_1>c and HOMA-IR by logistic regression analysis. Conclusions For middle-aged patients with type 2 diabetes, their cognitive functions such as learning ability, analysis and comprehensive capabilities are impaired. The cognitive function is closely related with HbA_1c and HOMA-IR.

Objective To investigate the genetic polymorphism of the transmembrane region of the MICA locus in Guangdong Han population,and to protract the genetic distance in different populations.Methods DNA samples from 106 unrelated Han individuals were genotyped by PCR to analyze the frequencies of MICA alleles.The genetic distance was estimated and the phylogenetic tree was protracted by DISPAN Software.Results In total,5 alleles of MICA-TM were observed,they were A4,A5,A5.1,A6 and A9.MICA-TM A5 was the dominant allele(0.2877),whereas A4 was the least popular one(0.1321).From genetic distance and phylogenetic tree we made,the preliminary finding is that Chinese Hans may have migrated from southwest China to northern and southern China.Conclusion MICA-TM locus has high genetic polymorphism and obvious variance in different populations.Since the genetic distance could be estimated effectively through MICA-TM locus,it could serve as the genetic marker in human migration and evolution research.

Objective　To study the relationship between the stress-related psychosocial factors and the psychosomatic symptoms of sterilized women. Methods　120 sterilized women were assessed with Symptom Check List 90(SCL-90),Social Supports Questionnaire(SSQ),Eysenck Personality Questionnaire(EPQ),Psychosocial Stress Scale for Group(PSSG)and a self-developed preoperative cognition scale.Data were analysed with SPSS. Results　There was a significant correlation between scores of psychosomatic symptoms and stress-related psychosocial factors such as EPQ-N,subjective social support(SSS),negative emotion(NE),positive emotion(PE),negative coping style(NC) and some negative characteristics of pre-operative cognition.Multiple stepwise regression analysis showed that EPQ-N,PE and religion belief were in the equation. Conclusion　The results indicated that neurotic syndrome of sterilized women may be mediated or influenced by negative characteristics of cognition,emotion,coping style and personality.

To investigate the kinetic expression of cytokine in allografts in rats and the effect of hydrocamptothecin on such expression, syngenic and allogenic heart transplantation models were developed. Recipient rats were divided into 3 groups: group A, SD-SD; group B, Wistar-SD group C,Wistar-SD plus treatment with HPCT 2. Omg/(kg ?d). The grafts and spleens were harvested on days 1, 3, 5, 7, and 14 post-transplantation for morphology and RT-PCR detecting the expressions of IL-2, IFN-?, IL-4, IL-10 mRNA. The results showed that the cytokine generally increased commensurately with the infiltration of this leukocyte population. The cytokine mRNA transcript could be detected on days 1 and 3 after transplantation in group A. The IL-2 and IFN-? mRNA transcript could be detected on days 1, 3, 5, 7 and 14 with a peak on day 7 in group B, but on day 3 in group C. The IL-4 and IL-10 mRNA transcript could be detected on days 1,3,5,7 and 14 with a peak on day 5 in group B, while on day 7 in group C. The levels of IL-2 IFN-? mRNA expression were significantly lower in grafts of group C than those in grafts of group B, whereas the levels of IL-4 and IL-10 mRNA were significantly higer in grafts of group C than those in grafts of group B. The level of cytokine mRNA expression in the grafts was similar to that of spleen of recipients. Our conculssion is the expression of cytokine mRNA in allografts can be detected on day 1 after transplantation ,with peaking of IL-2 and IFN-? on day 7, IL-4 and IL-10 on day 5. The survival time of allograft can be prolonged by HCPT. The levels of IL-2 and IFN-? mRNA expression can be reduced, while the levels of IL-4 and IL-10 mRNA expression be enhanced by HCPT.

Objective To investigate the accuracy of 64-detector helical CT in assessing stenoses of coronary arteries. Methods 64-detector helical CT angiography was performed in 128 patients with suspected coronary artery disease,and the results were compared with that of invasive coronary angiography. Results Among 128 patients, 1 724 of 1 920 coronary artery segments were assessable (90%). Overall sensitivity for classifying stenoses was 92%, specificity was 94%, positive predictive value was 82%, and negative predictive value was 96%.Conclusion 64-detector helical CT provides a high diagnostic accuracy in assessing coronary artery stenoses.

Objective To study the effect of lead exposure in different development periods (father BBLL and mother BBLL,MPBLL,UCBLL,IBLL,CBLL) on children behavior problems. Methods From 1996 to 2004,a nine-year epidemiological cohort study was conducted in a place with severe environmental lead pollution, Guichi district of Chizhou city in Anhui province, China. 210 newly-married couples with the intention to pregnancy and living around a lead and zinc smelt factory from Dec,1996 to Dec,1998 until delivery and then their offspring were chosen. 161 children were investigated through the questionnaires and Achenbach child behavior checklist(CBCL)at Nov,2001 and Aug,2004. Meanwhile, 210 couples baseline blood (father BBLL and mother BBLL), 93 mid-pregnancy blood(MPBLL), 98 umbilical cord blood (UCBLL),165 blood of infants(IBLL), 161 blood of children (CBLL) were collected to determined the levels of lead by PE-AA800 atomic absorption spectrophotometer. Results Geometric mean of mother BBLL, father BBLL, children BLL, infants BLL, UCBLL and MPBLL were (62.71?2.18)?g/L,(72.93?2.06)?g/L, (91.93?1.58)?g/L, (130.39?1.88)?g/L, (54.32?2.11)?g/L and (50.93?1.95)?g/L respectively,and the proportion of blood lead level at which were higher than 100 ?g/L were 32.38%, 38.10%, 45.34%, 43.03%, 10.20%, 9.68% respectively. In 161 infants, the incidence of abnormal behavior problems was 16.1%. The scores of delinquent and abruption in boys were significant higher than those in girls, while the scores of depression and social withdrawal in girls were higher than those in boys. The single correlative and the multiple stepwise regression analysis showed that the score of abruption was positively correlated significantly with MPBLL(?=0.162,P