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.

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 discuss the relative factors and clinical features of the elderly patients with craniocerebral trauma so as to improve the level of diagnosis and treatment of craniocerebral trauma.Methods A retrospective study was conducted on 139 patients with craniocerebral trauma treated in our department from June 2006 to August 2009. The post-injury pathogenesis, Glasgow Coma Scale (GCS)score, injury type, major complications and treatment method were summarized and analyzed to find the correlation of various factors with prognosis. Results It was revealed that the mortality was closely related with GCS score, injury type and post-tranmatic complications. The lower GCS score induced higher mortality. The high mortality was manifested in patients with craniocerebral trauma who presented diffuse cerebral edema, contusion and laceration combined with multiple hematomas and brain stem injury. The prognosis was impacted by lung infection, failure of respiratory function, hemorrhage in upper digestive tract, or simultaneous 2-3 complications after craniocerebral trauma. Conclusions The prognosis is directly affected by injury severity, injury type and complications of craniocerebral trauma. The elderly patients demonstrate delayed reaction, which deserves active early examinations and treatment to improve the prognosis.

Objective To explore the lymphcyte subsets distribution in cerebrospinal fluid in patients with HIV infection ,and to investigate the clinical significance of the lymphocyte subsets in cerebrospinal fluid in HIV central nervous system complication . Methods 34 patients with HIV infection ,including 20 patients without nervous system symptoms (simple HIV group) and 14 pa‐tients with nervous system symptoms (neurological HIV group) ,and 15 cases of healthy people (control group) were selected . Flow cytometry was used to detect lymphocyte subsets ,and immunoturbidimetry was used to detect the level of IgG in cerebrospinal fluid .Results The percentage of CD8+ T cells was higher and percentage of CD4+ T cells was lower in the simple HIV group and neurological HIV group than those in the healthy control ,with statistically significant differences (P<0 .01) .The level of IgG in pa‐tients with HIV infection was higher than that in the healthy control group (P<0 .01) .While no significant difference were found in the percentage of B cells and NK cells among the there group (P>0 .05) .There were also no significant differece between the sim‐ple HIV group and neurological HIV group in the ratio of each lymphcyte subset in cerebrospinal fluid (P>0 .05) .Conclusion The immune disorder in cerebrospinal fluid in patients with HIV infection may appear in the early time before the nervous system com‐plication .The changing trends of lymphocyte subsets are consistent with the peripheral blood ,which demonstrate that the T lym‐phocyte subsets may be correlated with the nervous system symptoms of HIV .

Objective To investigate the expression of muhidrug resistance-related protein 1 (MRP1),lung resistance-related protein(LfuP)and glutathione S-transferase-π(GST-π)in carcinoma of the gallbladder and cholangiocarcinoma. Methoils MRP1,LRP,GST-πwere measured in experimental group(18 cases of carcinoma of the gallbladder,36 CSSeS Of cholangiocarcinoma)and control group(13cases of cholecystitis and cholangeitis)by immunohistochemistry.Statistical analysis used chi-square test and spearman test. Results The positive rate of MRP1,LRP,GST-π in carcinoma of the gallbladder and eholangiocarcinoma were 72%(13/18),78%(14/18),61%(11/18)and 86%(31/36),75%(27/36),69%(25/36),respectively,significantly higher than those of 23%(3/13),23%(3/13),23%(3/13)(X2=4.5,P＜0.05)in control group.The expression of LRP[93%(13/14)]in pafients＞60 years old was significantly higher than 64%(14/22)in patients younger than 60 yrs old(x2=3.9,P ＜0.05).In addition,their expression was not related to gender,age,staging,tumor differentiation and lymph node metastasis(P＞0.05).The expression of MRP1 was related with tllose Of GST-π,Spearman correlation coefficient=0.569(P＜0.05).Conclusions MRP1,LRP,GsT-π were over expressed in various degrees in carcinoma Of the gallbladder and cholangiocarcinoma witllout chemotherapy.and related to the primary muhidrug resistance Of cholangiocarcinoma and carcinoma of the gallbladder.

Objective To investigate the effect of enteral and parenteral nutrition on gut microecology in rats with abdominal infection. Methods Fourteen Sprague-Dawley (SD) model rats of abdominal infection, which had survived for more than 6 days were divided into two groups: PN group ( n =7) and PN+EN group ( n =7) via jejunostomy and jugular vein respectively for another 5 days. The nutrition support in the two groups was isonitrogen and isocaloric. At sacrifice on the sixth day, occludin and IgA level in plasma cells of intestine epithelium of the gut were measured by immunohistochemistry. Vena cava blood and homogenated tissue of liver, lung and mesenteric lymph nodes were cultured to determine bacterial translocations, and portal vein blood was tested for endotoxin. Results The expression of occludin and IgA in the small and large intestine in PN+EN group were stronger than PN group ( P

Objective:To follow up the hepatitis B recurrence post liver transplantation using the combination of lamivu dine and high-dose intravenous/intramuscular hepatitis B immunoglobulin.Methods:Fifty-two consecutive patients who underwent liver transplantation were included in this analysis.All patients were administered lamivudine combined with hepatitis B immunoglobulin intravenous(V group)or intramuscular(M group)injection prophylaxis.Dosages of hepatitis B immunoglobulin were 4 000 U during anhepatic phase,2 000 U/d during the first six days after operation,2 000 U/week at 2-4 weeks after operation and 2 000 U/month at 2-6 months after operation.The dosages of hepatitis B immunoglobulin were decided by blood concentrations at 6 months after transplantation in both groups(HBsAb titer≥200 U/L during the 6-12 months after operation;100-200 U/L one year after operation).The negative-conversion rates of serum HBsAg,serum HBsAb levels and hepatitis B recurrence rate at the 6th month,1 year after transplantation and at the end of this study were investigated.Results:The daily average negative-conversion rate of serum HBsAg was significantly faster in V group than that of M group within the first 4 postoperative days(P ＜ 0.05).The 100% of serum HBsAg negative-conversion rate was obtained in two groups after one week of operation.No recurrence was found in two groups.And the ease of death was independent on HBV recurrent during the follow-up.Conclusion:Lamivudine combined with hepatitis B immunoglobulin intravenous/intramuscular injection prophylaxis was effective protocol for the hepatitis B recurrence after the liver transplantation.

Objective To study the expression of CDK4 andβ-Catenin and their relevance in glioma. Methods We used immunohistochemistry to detect the expression of CDK4 andβ-Catenin in forty-five glio-ma tissues and eight normal tissues.According to the classification standard of WHO in 2000 classify and grade the tissues.Results There were significant differences of CDK4 andβ-Catenin expressions between normal tis-sues and glioma tissues(P<0.01).The expression of CDK4 and β-Catenin had positive correlation with the pathological grades of glioma and histological type and increased(P <0.05).Furthermore,the expression of CDK4 was positively correlated with the expression ofβ-Catenin in glioma(r=0.52,P<0.01).Conclusion The increased expression of CDK4 andβ-Catenin may have correlation with malignant change of glioma and oc-curance of glioblastoma,and their combination is expected to become an important indicator in assessing malignant glioma.

Objective To observe the satisfaction of obtaining endometrial tissue in using endometrial sampling device and explore the influence for pathology diagnostic accordance rate,and to discuss the problem needs to focus in obtaining endometrial tissue with endometrial sampling device for endometrial cancer and precancerous lesion screening.Methods Totally 204 cases using endometrial sampling device with the subsequent diagnostic curettage,hysteroscopy,or hysterectomy were collected.A comparison of pathological diagnosis between two methods was made.The relationship among specimen quantity,proficiency,pathological types and diagnostic accordance rate were analyzed.Results The diagnostic accordance rate of endometrial cancer and precancerous lesion of two methods was 67％ (20/30).92.2％ (188/204) cases successfully got the endometrial glands,77.0％ (157/204) cases got ≥5 specimens of glands and 62.3％ (127/204) cases got ≥10 specimens of glands.When obtaining ≥5 but＜ 10 endometrial glands,the diagnostic accordance rate was 76.7％ (23/30); however,obtaining ≥10 endometrial glands,the diagnostic accordance rate was 92.9％ (118/127).The degree of specimen satisfaction of the first phase was lower than the second phase.Conclusions Obtaining ≥5 endometrial glands in using endometrial sampling device could satisfy the requirement of the basic pathological diagnosis.The proficiency of sampling and the pathological types could influence the degree of specimen satisfaction,and then influence the diagnostic accordance rate.