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.

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.

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.

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.

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.

ObjectiveTo evaluate the influence of laparoscopic operation on pH value, phagocytic function of neutrophil, immunoadhesion activity of RBC CR 1 (complement receptor typeⅠ) in abdominal cavity. Methods Determination of the pH value, phagocytic function of neutrophil, immunoadhesion of RBC CR 1 in abdominal exudatives during laparoscopic procedures was undertaken and results were compared with the relative indexes detected in peripheral vein blood. Results The average pH value was 7.41, the percentage of the phagocyte was 74.6%, phagocytic index 55.7, and immunoadhesion activity of RBC CR 1 was 58% in blood during laparoscopic operation. While the average pH value was 7.14, the percentage of the phagocyte 65.6%, phagocytic index 47.6,and immunoadhesion activity of RBC CR 1 50% in the abdominal exudatives. Conclusion Compared with the peripheral vein blood indexes, the intraabdominal pH value, phagocytic function of neutrophil and immunoadhesion activity of RBC CR 1 decreased significantly during laparoscopic operation. The intraabdominal inflammation may diffuse with the effect of CO 2 pneumoperitoneum when patients with serious inflammation receive laparoscopic operation.

Objective To analyze the distribution of tophus in ankle and tarsal joints by multislice spiral computed tomography (MSCT)and to explore the pathogenesis of gout.Methods 34 patients with a documented diagnosis of gout underwent CT examina-tion of bilateral ankle and tarsal joints,and 55 ankle and tarsal joints were observed tophus.The sites of tophus deposition were cate-gorized into groups of ligament,tendon and joint in order to record and analyze.Results The tophus were showed at the anterior talofibular ligament (n=38),the medial ligament (the site of talus and calcaneus)(n=30)and the interosseous talocalcaneal liga-ment (n=29)(P <0.05)in the group of ligament;at achilles tendon (n= 18),followed by tibialis posterior tendon (n= 7)(P <0.05)in the group of tendon;at articulations intercuneiformes (n=1 5)and inferior tibiofibular articulation (n= 10)(P <0.05 )in the group of joint.Conclusion In ankle and tarsal joints,tophus is commonly deposited at the anterior talofibular ligament,at the achilles tendon and the articulationes intercuneiformes.

BACKGROUND: Zero-P anterior cervical fixation system is an important means for treatment of cervical myelopathy in recent years. Zero-P fixation system can achieve effective decompression of spinal cord and nerve, and restore cervical curvature, with good stability.OBJECTIVE: To investigate the biocompatibility of Zero-P for multilevel cervical myelopathy.METHODS: Totally 62 patients with multilevel cervical disease who were treated by anterior cervical discectomy and fusion with Zero-P were selected, including double segments in 47 cases, three segments in 13 cases and four segments in 2 cases. Clinical efficacy was evaluated by pain visual analogue scale score, Japanese Orthopedic Association score, neck disability index score at postoperative 1, 6, 12, 24 months. Simultaneously, incidence of postoperative complications, cervical intervertebral space height and Cobb angle changes were observed.RESULTS AND CONCLUSION: (1) 54 patients were followed 2 years after treatment by clinic or telephone. Mean operative time was (102.00±32.41) minutes; average blood loss was (62.45±18.36) mL. (2) Two patients affected mild throat discomfort at one day after operation, and the symptoms went to lift six days after. The remaining patients did not experience any other complications. (3) Visual analogue scale score and neck disability index score at 1, 6, 12 and 24 months after operation were all less than preoperatively (P < 0.05); Japanese Orthopedic Association scores were higher than preoperatively (P < 0.05); the Cobb angle was improved significantly and greater than before treatment (P < 0.05).Postoperative cervical intervertebral space height was significantly higher than preoperatively (P < 0.05). Japanese Orthopedic Association results showed that among 54 patients, excellent was found in 34 cases, good in 14 cases,average in 6 cases and poor in 0 cases; the excellent and good rate was 89%. (4) Zero-P has a good clinical efficacy for multilevel cervical myelopathy, relieves symptoms significantly and restores cervical curvature and height, and has a good biocompatibility.

BACKGROUND: Bushen Huoxue Tongluo Capsule, a well-known traditional prescription, exhibits remarkable treatment outcomes in knee osteoarthritis, but the underlying mechanism is not fully understood. OBJECTIVE: To explore the regulatory effect of Bushen Huoxue Tongluo Capsule on miR-27a of synovial cells in Sprague-Dawley rats with knee osteoarthritis. METHODS: The model of knee osteoarthritis was established in 120 Sprague-Dawley rats using Hulth method, and then these rat models were randomized into four groups, followed by given75 mg/kg normal saline (blank control group), 34 (low-dose group), 75 (medium-dose group) and 140 (high-dose group) mg/kg Bushen Huoxue Tongluo Capsule aqueous solvent via gavage according to body mass, respectively, twice daily, for consecutive 2 courses (15 days as a course) with 2 days in between. The synovium and cartilages were removed after each course, and the expression of miR-27a in the knee joint synovium and chondrocytes was determined by real-time quantitative PCR. RESULTS AND CONCLUSION: Gross observation found that the degeneration of synovium and cartilage in the Bushen Huoxue Tongluo Capsule groups was milder than that in the blank control group. Real-time PCR revealed that there was an increasing trend in the expression of miRNA-27a in the synovium and cartilage in each group, especially in the high-dose group, and there was a significant difference between groups (P < 0.05). Our findings show that Bushen Huoxue Tongluo Capsule can suppress the reduced expression of miRNA-27a in the synovium and chondrocytes in rats with knee osteoarthritis, further alleviating knee degeneration and protecting the knee from damage.

BACKGROUND:Different anesthesia methods significantly impact mean arterial pressure, systolic and diastolic blood pressure, arterial blood pH and blood viscosity, but what kind of anesthesia method is more suitable for preparation of animal model does not reach an agreement. OBJECTIVE: To compare the effectiveness of local anesthesia and general anesthesia for preparation of rabbit intervertebral disc degeneration model in procession of percutaneous acupuncture rotary cut. METHODS:A total of 48 New Zealand white rabbits were randomly divided into the local anesthesia group and the general anesthesia group. The local anesthesia group was anesthetized with 0.5% lidocaine. The general anesthesia group was intraperitoneally injected with 3% sodium pentobarbital (30 mg/kg). In the two groups, models of intervertebral disc degeneration were established by minimally invasive percutaneous acupuncture rotary cut at L4/5, L5/6 levels. Modeling time was observed in both groups. Disc degeneration was evaluated by the gross observation, MRI detection, and histopathological examination at 4, 8, 12, and 16 weeks after modeling. RESULTS AND CONCLUSION: (1) General observation: the nucleus pulposus gradually with darker color and elasticity reduced in two groups after modeling. (2) MRI T2-weighted image results showed no significant changes in disc signal intensity at early stage, but the signal strength showed a decreasing trend with time. (3) Disc degeneration was evaluated according to Pfirrmann grading. Disc degeneration was gradually increased with time in two groups (P< 0.05), but there was no significant difference at postoperative time points in both groups (P > 0.05). (4) Masson staining showed that different degrees of annulus irregular arrangement appear in the two groups 8 and 12 weeks after modeling, but the structure was still intact. 16 weeks later, annulus disorganized, or even breakage in the two groups; no significant difference was detected between the two groups. (5) Safranin O staining showed that nucleus pulposus cells were not significantly reduced in the two groups at 4 weeks, but were significantly reduced at 16 weeks. (6) The average modeling time of local anesthesia group [(15.24±2.67) minutes] was significantly shorter than that in the general anesthesia group [(25.64±6.85) minutes] (P < 0.05). These results indicate that intervertebral disc degeneration model can be successfully established by minimally invasive percutaneous acupuncture rotary cut by using local anesthesia and general anesthesia; however, local anesthesia has a shorter operating time and simple anesthetic procedure. The efficacy was identical between the two methods.