For pharmaceutical industries, clinical data is one of the most valuable deliverables. It is also the basis of analysis, submission, approval, labeling and marketing of a drug product. To ensure the integrity and reliability of clinical data, a scientific standardized quality control (QC) has to be established at each step of a clinical trial. Data validation is conducted to ensure the reasonability and compliance of clinical data by checking data quality before the data is statistically analyzed. This paper focuses on purpose of data validation, creation of data validation plan, rationale of data validation, types of data validation and performance of user acceptance testing on clinical database.

For pharmaceutical industries, clinical data is one of the most valuable deliverables. It is also the basis of analysis, submission, approval, labeling and marketing of a drug product. To ensure the integrity and reliability of clinical data, a scientific standardized quality control (QC) has to be established at each step of a clinical trial. Data validation is conducted to ensure the reasonability and compliance of clinical data by checking data quality before the data is statistically analyzed. This paper focuses on purpose of data validation, creation of data validation plan, rationale of data validation, types of data validation and performance of user acceptance testing on clinical database.
Clinical Trials as Topic ; standards ; Data Accuracy ; Data Collection ; standards ; Databases, Factual ; Quality Control ; Reproducibility of Results

This paper is prepared to discuss the common issues in data management, such as building and training of data management team, standard operation procedure, document management, execution and communication, strategies to correct and prevent mistakes, and measures to improve the quality and efficiency of clinical trials and data management.
Clinical Trials as Topic ; Data Collection ; standards ; Information Storage and Retrieval ; standards

This paper is prepared to discuss the common issues in data management, such as building and training of data management team, standard operation procedure, document management, execution and communication, strategies to correct and prevent mistakes, and measures to improve the quality and efficiency of clinical trials and data management.

To identification the immunization activation of recombinant Leptospira gene vaccine from many-siden MethodsThe guinea pigs were immunized with recombinant Leptospira gene vaccine [plasmid vector pT7-7 was negtive control ,inactivated whole cell vaccine (WCV) was positive control]. Then spleen cells were taken out. Particularity lymphocyte transformation test(LTT),IL-2 and IL-6 activation of these spleen cells were determined by MTT and 3H-TdR respectively. Results1)The Relative transformation index of gene vaccine group was significance higher than pT7-7 group (vaccin group: 2. 19±0. 18, pT7-7 group 1.42±0. 27 ( P＜0. 005 ); 2 ) the activation of IL- 2 and IL- 6 from recombinant gene vaccine group waw significance stronger than pT7-7 group (vaccine group IL-2:34. 8±3.11,IL-6:94. 6±6.03, pT7-7 group IL-2:20. 4±3. 05,IL-6: 67±6.28), (P＜0. 005). Conclusion1) The activation of Th1 and Th2 lymphocyte cell were increased in the guinea pigs with gene vaccine immunized. It suggested the recombinant Leptospira gene vaccine could elicit an extremely strong immunization effect of T-cell cooperate with B-cell and the gene vaccine was equal the WCV(P＞0. 05)but the gene vaccine sideeffect was small and the applying prospect was good.

16?Gy) of STRS seems to reduce the incidence of rebleeding after radiosurgery. However,there is no histopathologic evidence of vascular obliteration in the resected CCA specimens after radiosurgery. The benefits and risks must be carefully balanced before the use of radiosurgery for cerebral cavernous hemangioma.

Objective: To analyze the service efficiencies of private hospitals in a Chinese city using Data Envelopment Analysis (DEA) method,and to discuss the problems existing in the management strategy of the hospitals. Methods: The management data of all the private hospitals were obtained by questionnaire survey and the parameters and samples were selected. DEA method was used to assess the service efficiencies of 58 private hospitals. Results: There were obvious differences on different aspects during their development between different hospitals. The total validities, the technical validities, and scale validities were obviously different. Twelve hospitals achieved total validity, 23 achieved technical validity, and 14 achieved scale validity. Conclusion: Most of the private hospitals in the city have defects in scale and technical validities. In order to achieve total validity in service efficiency, the private hospitals have to pay more attention to balanced development of technique and scale, while considering their own situation.

Objective To evaluate the efficacy and safety of sunitinib versus sorafenib in the first-line treatment of advanced renal cell carcinoma.Methods Forty-two patients with advanced renal cell carcinoma were divided into two groups according to the therapeutic method.Twenty patients were treated with sunitinib (50 mg, oral administration, once a day, for 4 weeks, drug withdrawal of 2 weeks, 6 weeks was a cycle) and 22 patients were treated with sorafenib (400 mg, oral administration, twice a day, until the disease progression, 6 weeks was a cycle).The efficacy and toxicity were evaluated every 2-cycle treatment.Results All 42 patients could be evaluated.The disease remission rate (RR), disease control rate (DCR) of sunitinib group and sorafenib group were 30.0％ (6/20), 22.7％ (5/22), 90.0％ (18/20), 77.3％ (17/22) respectively,the median progression free survival (PFS) were 10.8, 6.2 months, the median overall survival (OS) were 25.6, 18.6 months respectively.There were no statistical differences in the RR (x2 =0.287, P =0.592) and DCR (x2 =1.222, P =0.269) between the two groups.There were statistical difference in the PFS (x2 =6.041, P =0.014) and OS (x2 =11.245, P =0.001) between the two groups.The most common toxicities of the sunitinib group were diarrhea, fatigue, oral mucositis, nausea, vomiting, all these toxicities were mainly Ⅰ-Ⅱ degree, and could be well tolerated.The hand-foot syndrome rate of the sorafenib group obviously exceeded the sunitinib group (59.1％ vs.25.0％ , x2 =4.972, P =0.026).Conclusion Sunitinib has good efficacy in the first-line treatment of advanced renal cell carcinoma with less toxicity than sorafenib, so it is worthy of popularization.

Objective:To investigate the oral Candida albicans(CA)distribution in Uyghur children and to explore the gene type of CA in the children with high caries.Methods:The oral CA of 144 Uyghur children aged 3 -5 years was detected and identified by CHROMagar Candida medium culture,biochemical identification and PCR respectively.Gene type in 25 samples of high caries was de-tected by PCR25r-genotyping.Results:CA was found in 35(24.3%)of the children,and 25 of them with high caries.The gene type of CA was divided into type A,B and C,A was the major(72.0%).Conclusion:Oral Candida albicans may be related to childhood caries of Uygur population.Candida albicans with genotype A may be more cariogenic in Uygur children.

The quality and integrity of clinical trials and associated data are not only derived from accuracy of trial data analyses, but also closely embodied to the authenticity and integrity of those data and data documents as well as the compliant procedures obtaining those data and relevant files in the life cycle of clinical trials. The compliances of good clinical practices and standards suggest the reliability, complete and accuracy of data and data documents, which is constructing the convincible foundation of drug efficacy and safety validated via clinical trials. Therefore, the monitoring and auditing on clinical trials and associated data quality keep eyes on not only verifications of reliability and correctness on the data analytic outcomes, but also validation of science and compliance of the trial management procedure and documentations in the process of data collections.
Clinical Trials as Topic ; standards ; Data Accuracy ; Reproducibility of Results