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

ICH GCP requires that all information of clinical trial should be recorded, processed, and stored in a way that allows the accurate reporting, interpretation and verification. A trial master file (TMF) contains all paper or electronic records/documentations related to a clinical trial. As a tool of the retrospective analysis, the TMF profile should be able to reproduce the full procedure of the trial completely. As a part of TMF profiles, both the accuracy and completeness of clinical data management documentation are important in data integrity. It is helpful to learn the workflow of clinical data management in different stage of a clinical trial, to understand which documents are essential, and why the documentation of clinical data management is important for data integrity. This paper elaborates how to perform the good documentation practice of clinical data management, and suggests that both the precise and efficient document management and regular quality control may ensure the high quality of clinical data documentation management on the basis of an intensive awareness of the overall process of clinical data management.
Clinical Trials as Topic ; Data Curation ; standards ; Information Storage and Retrieval ; methods ; standards

Objective To explore the clinical value of 18F-FDG PET/CT in the diagnosis of cardiac neoplasm.Methods Between January 2007 and December 2011,18F-FDG PET/CT was performed in 8649 patients in our hospital,and 14 (0.16％ ; 11 males,3 females,average age 46.9 (35-68) years) patients were diagnosed with cardiac neoplasm.18F-FDG PET/CT data of those 14 patients were retrospectively analyzed.Final diagnoses were confirmed by either histopathology (n =5) or follow-up (n =9).Results Accurate tumor localization and diagnoses were made by 18 F-FDG PET/CT in all 14 patients.Among them,13 were malignant (2(14.3％,2/14) primary and 11(78.6％,11/14) metastatic tumors (8 HCC,2 lung cancer,1 esophageal cancer) ; SUVmax 3.2-10.7) and 1 (7.1％,1/14) was benign (myxoma).Conclusion 18F-FDG PET/CT is useful for the detection and staging of primary malignant and metastatic cardiac neoplasms.

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

A perfect clinical trial must nave a solid study design, strict conduction, complete quality control, non-interference of statistical result, and acceptable risk-benefit ratio. To reach the target, the quality control (QC) should be performed from the study design to conduction, from the analysis to conclusion. We discuss the relationship between data management and biostatistics from the statistical point of view, and emphasize the importance of the statistical concept and methods in the improvement of data quality in clinical data management.
Biostatistics ; Clinical Trials as Topic ; statistics & numerical data ; Data Collection ; standards ; Quality Control ; Research Design ; standards

Objective To evaluate the usefulness of diffusion-weighted imaging(DWI) in the diagnosis and differential diagnosis of gallbladder wall thickening diseases.Methods 42 patients with gallbladder wall thickening (16 patients with carcinoma and 26 patients with benign lesion) were included in this study.All patients performed conventional MRI and DWI.The diagnostic performances of three methods (conventional MRI,visual assessment of color fusion image from DWI and T2WI,and ADC measurement) were evaluated by two radiologists.Results The area under the receiver operating characteristic curve were 0.570,0.849,0.901 for conventional MRI,visual assessment and ADC measurement respectively.The accuracy,sensitivity and specificity were 59.5%,62.5%,57.7% for conventional MRI,85.7%,81.2%,88.5% for visual assessment of color fusion image,and 83.3%,80.0%,85.2% for ADC measurement,respectivily.The mean ADC value of gallbladder cacinoma[(1.15±0.35)×10-3mm2/s]was significantly less than that of gallbladder benign lesion [(1.99±0.61)×10-3mm2/s](P<0.01).Conclusion The DWI(visual assessment of color fusion image and ADC measurement)might be a useful tool for diagnosis and differential diagnosis of the gallbladder wall thickening diseases.

Objective To investigate the value of 18F-FDG PET/CT in the phasing and grading of renal cell carcinoma (RCC) complicated with vena cava tumor thrombus (VCTT).Methods From December 2011 to September 2015,a total of 72 patients (52 males,20 females,age:36-74 years) were enrolled in this retrospectively study.All patients underwent 18F-FDG PET/CT and contrast-enhanced CT studies,and were diagnosed as RCC.The RCC patients combined with VCTT were classified by Mayo-level.Wilcoxon rank sum test was used to compare the grading of VCTT by PET/CT and contrast-enhanced CT.NM staging on abdominal area level was performed and the results were compared with x2 test.Results VCTT was identified in 18 RCC patients and the grading results by PET/CT were as follows:9 cases in Level 0,4 cases in Level Ⅰ,2 cases in Level Ⅱ,1 case in Level Ⅲ,and 2 cases in Level Ⅳ.When evaluated by PET/CT,20 cases were in N0M0,21 were in N1M0,9 were in N0M1,and 22 were in N1M1.NM staging results by contrast-enhanced CT were as follows:50 cases in N0M0,10 in N1M0,10 in N0M1,and 2 in N1M1.In addition,2 N1 and 2 M1 were found by the whole body PET/CT.The classification results of VCTT and staging of abdominal level by PET/CT were significantly better than those by contrast-enhanced CT (z=-2.462,P＜0.05;x2=32.806,P＜0.01).Conclusion 18F-FDG PET/CT is not only valuable for detecting primary RCC and local metastasis,but also useful for finding where the VCTT extends,which is conducive to therapeutic planning and further clinical treatment.

Actins ; metabolism ; Adenoma, Pleomorphic ; congenital ; metabolism ; pathology ; surgery ; Diagnosis, Differential ; Fibrosarcoma ; metabolism ; pathology ; Humans ; Infant ; Male ; Nasopharyngeal Neoplasms ; congenital ; metabolism ; pathology ; surgery ; Rhabdomyosarcoma ; metabolism ; pathology ; Salivary Gland Neoplasms ; congenital ; metabolism ; pathology ; surgery ; Vimentin ; metabolism

Objective To investigate the mechanism and epidemiological characteristics of carbap-enem-resistant Proteus mirabilis ( PM) strains deficient in swarming motility. Methods PM strains were isolated from Hangzhou General Hospital of CAPF ( Chinese People′s Armed Police Forces) during January 2013 to December 2014. Bacterial motility and flagella of the PM strains were observed through semi-solid agar culture and flagella staining. Pulsed-field gel electrophoresis ( PFGE) was performed for homology anal-ysis. Antimicrobial susceptibility test and phenotypic confirmatory test were also carried out. PCR analysis and DNA sequencing were performed to confirm the genotype of resistant genes. Plasmid electroporation and S1-PFGE in combination with Southern blot hybridization were used to determine the location of the carbap-enem-resistant genes. Genetic structure of the blaKPC-2 gene was obtained by PCR mapping. Results A total of 42 PM isolates deficient in swarming motility were screened out and the resistance rates to imipenem and meropenem were 57. 1% and 52. 4%, respectively. PCR analysis and DNA sequencing confirmed that 24 carbapenem-resistant PM isolates deficient in swarming motility carried blaKPC-2 gene and belonged to three clones as indicated by the results of PFGE. Southern blot hybridization indicated that the blaKPC-2 gene was located on plasmids varying in size (26 kb, 55 kb and 139 kb). In addition, some of the strains harbored several resistant genes, such as blaTEM-1 , blaCTX-M-65 and rmtB. The genetic structures of strains carrying blaKPC-2 gene were ISKpn8, blaKPC-2 and ISKpn6-like from upstream to downstream. Conclusion Compared with the PM strains with swarming motility, the carbapenem-resistance rate was significantly higher in these PM strains deficient in swarming motility. Carbapenemases KPC-2 played an important role in the carbapen-em-resistant PM strains deficient in swarming motility. There was a cloning spread trend for carbapenem-re-sistant PM strains in our hospital. Clinicians should pay more attention to the risk of spreading.

Objective To investigate the dynamic changes of articular cartilage destruction and nitric oxide nitric oxide/inducible nitric oxide synthase (NO/iNOS).Methods Forty healthy adult male Wistar rats were randomly divided into control group (free movement) and experimental group (overtraining).Total knee joints of rat were collected at week 0,1,2,3,and 6,fixed with 4％ PFA,embedded in paraffin,sectioned and stained.Cartilage morphological changes were observed by Safranin-O staining,NO/iNOS content changes in serum and synovial fluid were determined by ELISA,Mankin's scores were obtained,and cartilage pathological changes were analyzed.Results Overtraining resulted in cell sorting disorders,loss of matrix,destruction like rough surface and cracks,and degeneration of cartilage pathology process.Levels of NO/iNOS in serum and synovial fluid increased after overtraining:week 1 (48.088 ± 1.534),(3.058 ± 0.073);week 2 (54.574 ± 0.800),(6.630 ± 0.524);week 3 (68.020 ± 3.184),(7.384 ± 0.306);weeks 6 (104.394 ± 8.094),(11.364 ± 0.882) Levels of NO/iNOS in synovial fluid group were:week 1 (65.814 ±1.610),(8.126 ±0.724);week 2 (72.766 ± 2.344),(9.694 ± 0.564);week 3 (88.816 ± 0.819),(11.326 ± 1.473);week 6 (120.204 ± 12.044),(15.166 ± 1.198),and high level of concentration was found with the increasing amount of exercise.Conclusion There is a positive correlation between the levels of NO/iNOS in synovial fluid or serum and the extent of the damage of articular cartilage.