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.

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

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 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.

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 study the significance of ?-catenin expression in human gastric carcinomas, colorectal carcinomas and human hepatic carcinomas.Methods S-P immunohistochemical method was used to detect ?-catenin expression in 80 cases of human carcinomas of alimentary system and corresponding tumor-adjacent normal tissues by ?-catenin polyclonal antibody. The results were analyzed using densitometrically semiquantitated .Results ?-catenin were normally expressed in all tumor-adjacent normal tissues of digestive system. ?-catenin expression was reduced or negative in human carcinomas of alimentary system (P

Objective To find out about the characteristics and prognosis of retinal detachment due to ocular contusion. Methods The clinical data of 36 patients (36 eyes) with retinal detachment due to ocular contusion were retrospectively analyzed. Results There were 3 eyes (8.3%) with huge retinal hole (≥90?), 4 eyes (11.1%) oral tear of ora serrata retinae, 4 eyes (11.1%) with macular hole, 3 eyes (8.3%) with tractive retinal detachment, and 22 eyes (61.2%) with retinal hole (

Objective: To study the influence of the Ewi-anticarcinogen Prescription on associated gene protein in process of rat hepatocarcinoma induced by diethylnitrosamine (DEN). Methods: Rats hepatocarcinoma model was induced by DEN, while the Eqi-anticarcinogen Prescription was used during the stage. At the end of 12th week and 16th week, the influence of the Eqi-anticarcinogen Prescription on positive expression of PCNA and p53 protein were examined by immuneohistochemical method. Results: The positive expression of p53 protein was occurred in precancerous hyperp lastic nodules; The Eqi-anticarcinogen Prescription can significantly inhibit the overexpression of p53 (P

Objective To study the assiociation of-866G/A polymorphism in the promoter of uncoupling protein 2(UCP2)gene in patients with type 2 diabetes and B-cell function in Han population in Nanjing.Methods For the case-control study,PCR-RFLP method was used to determine the distributions of allele and genotype frequencies of-866G/A polymorphism in the human UCP2 gene in 229 type 2 diabetic patients and 196 normal control subjects.All of the testees accepted oral glucose tolerance test and insulin releasing test to detect B-cell secretion function and insulin sensitivity.Results The distribution of genotype and allele frequencies of-866G/A polymorphism in the promoter of the human UCP2 gene were significantly different between type 2 diabetic patients and normal control subjects(?2=6.555,P=0.038;?2=6.363,P=0.012 respectively).The frequency of A/A genotype and A allele in type 2 diabetic were significantly higher than that in contrast(OR=1.99,OR=1.42 respectively,both P

Objective To evaluate the percentage of agreement between the ultrasonographic data and the surgical findings,and investigate the characteristics of the ultrasonographic imaging of proliferative diabetic retinopathy.Methods B-scan ultrasonography was performed in 48 patients (62 eyes ) affected by proliferative diabetic retinopathy,before vitreoretinal surgery,by observing and recording the position,shape,range,to evaluate the percentage of agreement between the ultrasonographic data and surgical findings.Results Ultrasonography can show kinds of vitreoretinal changes clearly,and is not affected by the opacity of refractive media.The agreement was quite good for the pathological changes of proliferative diabetic retinopathy.The accurate rates of diagnosis of vitreous hemorrhage,posterior vitreous detachment,retinal detachment,vitreal membranes,vitreoretinal adhesions and preretinal membranes were 100%, 91.9%, 94.9%, 96.4%, 80.0% and 87.9%,respectively.Conclusions B-scan ultrasonography is valuable in proliferative diabetic retinopathy and favorable in the ophthalmic clinic practice.