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 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.

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.
Clinical Trials as Topic ; Data Collection ; standards ; Documentation ; standards

To explore the influences of pregnancy and iodine intake on thyroid function and immune functions, 210 pregnant women and 290 fertile women were chosen from iodine excess area, and the average ages of them were (27. 69±4. 73 )and (30. 62±6. 01 )years respectively. Fasting blood and urine were collected in the morning. The urinary iodine level was determined by arsenic-cerium catalytic contact. Serum free triiodothyronine ( FT3 ), free thyroxine ( FT4 ), and sensitive thyroid-stimulating hormone ( sTSH ) levels were measured by chemiluminescence.Thyroid peroxidase antibody (TPOAb)and thyroglobulin antibody (TGAb)were measured by radioimmunoassay. The median urinary iodine in the pregnant and fertile women were I 240. 70 and 949. 21 μg/L, respectively. There were 84. 3% pregnant women and 81.0% fertile women admitting excess iodine intake. The prevalence of overall thyroid diseases was 22. 9% in the pregnant women and 30. 3% in the fertile women. The prevalence of hyperthyroidism,subclinical hyperthyroidism, hypothyroidism, and subclinical hypothyroidism was0. 5%, 1.9%, 0. 5%, and 20. 0% in the former group, and 2. 8%, 0. 3%, 0. 3%, and 26. 9% in the latter. Both FT3 and FT4 levels of the pregnant women were lower than those of fertile women [(4. 03±0. 59 vs 4. 71 ± 1.04)pmol/L, ( 13. 35 ± 1.59 vs 14. 27 ±3.63 )pmol/L,both P＜0. 01], and the positive rate of TGAb of pregnant women was also lower than that of fertile women (7. 1% vs14. 1%, P=0. 014). The prevalence of thyroid diseases and positive rate of thyroid autoantibodies is high in women with excess iodine intake. Compared with fertile women, pregnancy may lead to decreas~s in level of thyroid hormones and positive rate of TGAb. Their iodine intake should be controlled, and the thyroid function and autoimmunity antibodies should be monitored.

OBJECTIVETo explore clinical results of open reduction and internal fixation (ORIF) for posterior Pilon fracture through posterolateral approach.

METHODSSeventeen patients with posterior Pilon fracture were treated through posterolateral approach from February 2010 to April 2013. Among them,including 11 males and 6 females aged from 29 to 59 with an average of 43.4 years old. All fractures were associated with more than 20% of articular surface of distal tibial. The causes of injury included falling down (11 cases), traffic accident (4 cases) and sports injury(6 cases). Fracture classification was based on posterior pilon fracture by YU Guang-rong, including type I (6 cases), type II (2 cases) and type III (6 cases). Fracture healing time, fracture reduction and postoperative complications were observed, AOFAS score were applied to evaluate clinical efficacy.

RESULTSAll patients were followed up from 13 to 24 months with an average of 20.5 months. All incisions were healed at stage I, and fractures obtained healing,the time of fracture healing ranged from 12 to 21 weeks with an average of 15.2 weeks. No incision infection, neurovascular injury, bone ununion and fracture deformity were found after operation. Postoperative AOFAS score was 92.0 ± 10.2, and 14 cases got excellent results, 2 good and 1 moderate.

CONCLUSIONPosterior pilon fracture through posterolateral approach could obtain effective reduction, stable fixation. It is a safe, simple and effective operation for treating posterior Pilon fracture, and it is worth popularizing.

Adult ; Ankle Fractures ; surgery ; Ankle Joint ; surgery ; Female ; Fracture Fixation, Internal ; Humans ; Male ; Middle Aged ; Tibial Fractures ; surgery

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 discuss the clinical effects of hemiarthroplasty for the treatment of intertrochanteric comminuted fracture in aged patients.Methods From June 2006 to June 2010,91 cases with intertrochanteric comminuted fractures were treated by hemiarthroplasty using Zweymtüller long-stem cementless implant.There were 35 males and 56 females,with an average age of 81.2 years (range,75-94 years).There were fresh fractures in 75 cases and old fractures in 16 cases.According to classification of Evans-Jensen,there were 36 cases with type Ⅲ fracture and 55 with type Ⅳ.Osteoporosis was graded by Singh index,and there were 51 cases with level Ⅲ and 40 with level Ⅱ.The interval between injury and operation was 2-10 d (average,3.5 d).Results The surgery lasted 30-50 min (average,39 min).The blood loss was 320-610 ml (average,405 ml).The hospital stay was 14-21 d (average,16.5 d).Two cases who experienced with the infection of the respiratory system after operation,recovered through routine treatment.Thirty-seven cases were followed up for 15 to 38 months (average,24.5 months).According to the Harris score,the overall rate of excellent or good result was 83.8％ (31/37).Conclusion Hemiarthroplasty using Zweymüller long-stem cementless prosthesis is reliable option for intertrochanteric comminuted fracture in the aged patients.

Objective To explore genes expression of adiponectin receptors during differentiation of SW872 preadipocytes. Met-(hods) SW872 preadipocytes were cultured in vitro and induced to differentiate by 0.6 mmol/L oleic acid. During the progress of diffe-(rentiation), the morphological changes of SW872 cells were observed and the differentiation rate was assayed by oil-red O staining. Adiponectin receptors mRNA was measured by reverse transcription-polymerase chain reaction during differentiation of SW872 preadipocytes. Results 1.After stimulated by 0.6 mmol/L oleic acid for 72 hours, almost all SW872 cells were differentiated,and there were lots of fat droplets in the cells.2.There were adiponectin receptors genes expressions in SW872 preadipocytes.After 72 hours,and the levels of adiponectin receptor(AdipoR) 1 mRNA and AdipoR 2 mRNA were markedly increased up to 2.54 and 4.09 times,respectively. Conclusion There are AdipoR1 and AdipoR2 genes expressions in fat cells and the expressions are differentiation-dependent.

Objective To study the effect of oleic acid on the differentiation of SW872 preadipocytes.Methods SW872 prea-(dipocytes) were cultured and induced to differentiate by 0.6 mmol/L oleic acid in vitro.After 24 h,48 h and 72 h of differentiation,the morphological changes of SW872 preadipocytes were observed and the differentiation rate was assayed by oil-red O staining.In addition,triglyceride(TG) mass was detected by chemical colorimetry methods.During the differentiation of SW872 preadipocytes,transcription factors including peroxisome proliferator activated receptor-?_2(PPAR-?_2) and CAAT/enhancer binding protein-?(C/EBP-?)(mRNA) were also measured by reverse transcription-polymerase chain reaction(RT-PCR).Results 1.SW872 preadipocytes were fibroblastic and had no obvious fat droplet in cytoplasm.However,when stimulated for 72 hby 0.6 mmol/L oleic acid,SW872 preadipocytes became more bigger and rounder and differentiated into mature adipocytes with lots of fat droplets in the cells.2.Compared with that of predifferentiation,the concentration of TG mass increased by 14 folds after 72-hour differentiation(P

Background The fundus autofluorescence (FAF)can reflect the function of retinal pigment epithelium(RPE) cell.As an invasive examination,it has been extensive used in retina disease,but there has not any report in syphilitic posterior uveitis.Objective This study was to characterize and contrast the FAF and fundus fluorescein angiography (FFA),indocyanine green angiography (ICGA) findings in patients with syphilitic posterior uveitis.Methods A retrospective series of cases observational study was designed.The clinical data of 27 eyes from 18 patients with syphilitic posterior uveitis were included in Shanghai First People's Hospital from 2010 May to 2012 October,and all the patients were diagnosed by serologic and ophthalmic tests.The patients were assigned to acute stage group(with the course ＜2 months)and chronic stage group(with the course ≥ 2 months).FFA,ICGA and FAF were performed respectively on all the patients,and the examination results were compared and analyzed.Results In the affected eyes with syphilitic posterior uveitis,the FFA image showed a retinal vasculitis sign and mottle-like fluorescence appearance in posterior pole and equator zone,and some affected eyes exhibited edema of optic disc and macula.Hypoautofluorescence zone was seen in the acute stage group and cystoid macular edema was found in the chronic stage group.ICGA presented with a wider damage of RPE,especially in the later phase of ICGA.A confluent of hyperautofluorescence with hypoautofluorescence in the posterior fundus,punctiform hyperautofluorescence as well as hypoautofluorescence in papillitis and macular edema were found on the FAF image.Conclusions The pathological basis of syphilitic posterior uveitis is retinal vasculitis and papillitis.ICGA indicates the damage of choroid membranes and RPE,and FAF reflects a metabolism disorder of RPE in the acute stage and atrophy and loss of RPE in the chronic stage.FAF is helpful for the diagnosis of syphilitic posterior uveitis as an assistant index.