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.

Objective To study the distribution of rifampin(RFP), isoniazid(INH) and pyrazi-namide(PZA) in the focus of spinal tuberculosis in order to provide the regimen of chemotherapy and surgi-cal treatment of spinal tuberculosis. Methods Twenty-four patients with spinal tuberculosis were divided into sclerotic group or non-sclerotic group according to the radiographic features of lesion. All patients re-ceived chemotherapy with 2SHRZ/2.5 H2R2Z2 for a duration of 4.5 months. 4 weeks after chemotherapy, all patients underwent surgery and specimen of serum, ilium and vertebral tissues including sclerotic wall, sub-normal osseous tissue, focus inside sclerotic wall (sclerotic group) and destructive focus, peripheral subnor-mal osseous tissue (non-sclerotic group) were obtained during operation at 120-130 and 180-190 minutes after oral intake in the morning respectively. The levels of 3 drugs in the specimen were measured using HPLC method. Results 1) The concentration levels of INH and PZA in serum were similar to the data in the literature, but the level of RFP was only 75% of that in the literature. The levels of 3 drugs in osseous tissue were significantly less than those of blood. 2) Concentrations of isoniazid and rifampicin in self-control ilium and sub-normal bone tissue were within or exceeded the bactericidal concentration values,and pyrazi-namide was five fold of it's minimal inhibitory concentration (MIC) in acid cellular condition. There were no significant differences between sub-normal bone and self-control ilium of 3 drugs concentration. 3) Concen-tration of 3 drugs in sclerotic bone wall were approximate to MIC respectively in sclerotic group and much lower than sub-normal bone. There was no drug distribution of focus inside sclerotic bone wall. 4) RFP and PZA in focus of non-sclerotic group corresponded to the levels of MIC respectively, though much lower than in other parts of vertebral tissues, but the INH in focus was of bactericidal level. Conclusion The sclerotic bone of affected vertebra plays an important role to block the drug's penetration into tuberculosis focus.

Objective To investigate the clinic effect of trans-artery intrahepatic transplantation of porcine islet in type 1 diabetic patients. Methods Four patients with type 1 diabetes were perfused newborn porcine islets through the hepatic artery.Fasting blood glucose(FBS), postprandial blood glucose (PBS), HBA1,dose of insulin and function of liver and kidney were measured before and after the transplantation.Results The levels of FBS,PBS and HBA1 were 7 4～13 5mmol/L,7 8～18 6mmol/L and 7 8～12 0mmol/L respectively before the transplantation. During one and half years after transplantation, the levels of FBS,PBS and HBA1 were 3 3～7 1mmol/L,6 0～8 8mmol/L and 6 4～7 6mmol/L respectively with notably reduced dosage of insulin(32～58%).The function of liver and kidney of the patients remained normal.Conclusions Trans-artery intrahepatic transplantation of porcine islet is effective and safe for type 1diabetic treatment.

Objective To study the diagnosis and therapy of Hashimoto's disease (HD) with thyroid nodule. Methods The clinical data of 187 patients with nodulous Hashimoto's disease who had operation in our hospital from 1995 to 2008 were analysed retrospectively. Results The nodules coexisting with Hashimoto's disease were thyroid carcinoma, nodular goiter, thyroid follicular adenoma and lymphoma accounting for 11.2% (21/187), 26.7% (50/187), 15% (28/187) and 1.6% (3/187) respectively. Conclusions HD patients with thyroid nodules especially the single nodule that can not be distinguished from cancer should have operation in time. Ultrasound guided needle aspiration will be helpful for the preoperative diagnosis and the frozen section may guide the surgical modality.

Objective To establish a method for determining the content of Naringin and Hesperidin in Zengshi Keli by HPLC. Methods The Kromasil C18 column with acetonitrile-water-phosphoric acid (20∶80∶0.02) as the mobile phase was used. The flow rate was 1.0 mL/min, the detective wavelength was 283 nm, the temperature of column is 35 ℃. Results The calibration curve were linear in the range of 0.178 5～0.892 5 ?g for Naringin and 0.073 68～0.368 4 ?g for Hesperidin (r=0.999 9) respectively. The average recovery was 97.24% (RSD=1.21%) and 96.95% (RSD=1.49%) respectively. Conclusion The method was simple, accurate, reproducible and can be used for quality control of Zengshi Keli.

Objective To develop the cDNA microarray for the combined detection of hepatitis virus, and to study the feasibility of applying the microarray in clinical setting. Methods For the small and simple genome of HBV and HDV, the specific primers of PCR were designed with Primer Premier 5.0 program according to the conserved region of HBV and HDV, and 10 and 4 gene fragments were obtained respectively, which could be used as the probes of gene chip. As for the complex genome of HCV, the technique of restriction display PCR (RD-PCR) was employed. Some of gene fragments were selected which were comparatively more specific and sensitive as microarray probes. In order to explore the experimental conditions of microarray in vitro detection, three types of gene chip were prepared successively including HBV and HDV simultaneous detection, HCV detection and modified HCV detection. Results The hybridized signals on the gene chip showed that the effect in detection was satisfactory. Through the prepared gene chips mentioned above, some probes with good quality were selected and the microarray was prepared for HBV, HCV and HDV simultaneous detection. The diagnostic capability of the microarray was evaluated following the washing and scanning steps. Linearity: Serial dilutions of the target DNA or cDNA showed that a strong linear relationship existed between the various concentrations of target DNA or cDNA and the fluorescence intensities obtained from microarray assay (r=0.990 2, r=0.992 1, r=0.981 9), and that the detection range for the microarray was from 104 to 1011 copies/ml. Specificity: Samples from other viruses such as YFV, JET and DV were also subjected to the test and the results were all negative. Reproducibility: The reproducibility of this assay system was evaluated by repeated measurements, and the within-run coefficient of validation of HBV, HCV and HDV were 7.1%, 7.2% and 6.6%, respectively, while the between-run coefficient of validation was 7.9%, 8.2% and 7.6%, respectively. Accuracy: By using the BLAST and the GenBank database, the identity of the obtained sequences including 16 fragments of PCR, 24 RD fragments of HCV and some positive serum samples were verified, each sequenced product was confirmed to be a genome fragment of expected size. In order to fulfill the request of clinical diagnosis, a modified protocol for microarray detection was established. This new protocol consisted of two hours of hybridization, omitting the steps of prehybridization and purification of samples, and the hybridization temperature was elevated from 42℃ to 52℃, et al. The whole protocol could be completed in less than 8 hours. 98, 42 and 5 serum samples from hepatitis B, C and D patients and 130 samples from healthy people were analyzed, respectively, by microarray assay and real-time PCR (Taqmam method). There was a significant correlation between the results of these assays (HBV, r=0.985 4 and HCV, r=0.958 2, P

This list of clincal data management documentation is to ensure standardized and adequate archival of trial documents and records in clinical data management, which is applicable to all of phase I-IV clinical trials.

Objective To explore the expression of ErbB3 in osteosarcoma cell lines Saos-2 and its significance.Methods Real-time quantitative PCR was used to detected ErbB3 mRNA expression in osteosarcoma cell lines Saos-2 and normal human osteoblasts cell lines N704,and Western blotting was used to detected ErbB3 protein expression.Short hairpin RNA was used to construct ErbB3 knockdown cells and the cell count in 0-3 d was detected.The 48 h survival rates of ErbB3 knockdown cells and normal Saos-2 cells were detected in the presence of 0-100 μmol/L paclitaxel.Results Real-time quantitative PCR showed significant enhanced ErbB3 mRNA expression in Saos-2 cells compared with N704 [(4.15 ± 0.04) times,t =7.31,P ＜0.05],and Western blotting showed significant enhanced ErbB3 expression in Saos-2 cells compared with N704.As compared with normal Saos-2 cells,ErbB3 knockdown could reduce the Saos-2 cells proliferation,at the first three days in culture,the Saos-2 cell number of ErbB3 silent was (22.2 ± 2.9) thousand,and the control was (45.8 ± 4.1) thousand,with statistical significance (t =8.23,P ＜ 0.05).Moreover,ErbB3 knockdown could reduce the Saos-2 cells tolerance to paclitaxel,when treated with 20 μmol/L paclitaxel,surviving cells in ErbB3 silent group was (43.2 ± 4.7) ％,and the control was (61.4 ± 5.9) ％,with statistical significance (t =6.74,P ＜ 0.05).Conclusion ErbB3 highly expresses in Saos-2 cells,ErbB3 expression can enhance the proliferation of Saos-2 cells and the tolerance of Saos-2 cells to paclitaxel.

BACKGROUND:Recent studies have proved the presence of adjacent vertebral fractures after percutaneous kyphoplasty, suggesting that cement leakage may be an important reason. OBJECTIVE:To investigate the effect of bone cement amount during percutaneous kyphoplasty on adjacent vertebral endplate using finite element analysis. METHODS: Three-dimensional finite element pathological model of Osteoporotic vertebral compression fracture was established using finite element analysis, and 10%, 20% and 30% volume of bone cement were filed, respectively. Then the adjacent vertebral endplate stress under the axial compression, anteflexion and rear protraction were analyzed. RESULTS AND CONCLUSION: Compared with that before operation, the adjacent vertebral endplate stress increased with the increase in filed bone cement volume, suggesting that the increased amount of bone cement wil lead to the increasing of adjacent vertebral re-fractures.

BACKGROUND:The age, complication, injury to operation time, and pain level are important factors that affect patients with postoperative mortality, but many scholars disagree. Factors affecting death in elderly patients after femoral head replacement stil need further study. OBJECTIVE:To observe factors related to the survival status of elderly patients within 1 year after receiving femoral head replacement. METHODS:A total of 96 elderly patients receiving femoral head replacement at Department of Orthopedics, the First Affiliated Hospital of Xi’an Jiaotong University from January 2011 to January 2014 were selected. On admission, patients’ age, sex, time from injury to operation, injury to admission time, pain classification, admission hemoglobin, serum albumin content of admission, admission lymphocyte count, and the amount of blood transfusion and preoperative complications were recorded. Fisher test was used to analyze the factors affecting survival status within 1 year after replacement in patients with femoral head replacement using one-way analysis of variance. Multivariate Cox test was utilized to perform multi-factor analysis. RESULTS AND CONCLUSION: The injury to hospital time was > 5 days. Pain classification was grades III and IV. The hemoglobin content was < 120 g/L on admission. The volume of blood transfusion was > 1 000 mL. Serum albumin content was < 35 g/L, which was associated with the increased mortality (P < 0.05). The mortality was significantly higher in patients with more than 86 years old than in patients with 70-85 years old (P < 0.05). The mortality of patients with the time from injury to operation > 7 days was significantly higher than patients with the time from injury to operation < 7 days (P < 0.05). The serum albumin content < 35 g/L and grades III and IV of ASA classification were factors related to patient’s death (P < 0.05). Results confirm that the risk factors for survival status within 1 year of femoral head replacement contain intraoperative volume of blood transfusion, admission to operation time, hemoglobin content, and grading of pain.