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

The mRNA levels of adiponectin in adipose tissue and adiponectin receptor R1 in skeletal muscle of type 2 diabetic rats were examined by semi-quatitative RT-PCR.The expression of adiponectin receptor R1 was not altered in the skeletal muscle of type 2 diabetic rats as compared with normal rats.The serum adiponectin level was decreased in diabetic rats due to the decline of adiponectin mRNA level in adipose tissue and rosiglitazone improved the adiponectin deficiency.

SW872 cells were cultured in vitro with oleic acid and differentiated into mature adipocytes. The role of interleukin-6(IL-6)in the secretion of acylation-stimulating protein(ASP)in mature SW872 adipocytes was observed.The results suggested that IL-6 significantly inhibited ASP secretion into the media in a dose-and time-dependent manner in mature SW872 adipocytes.

SW872 preadipocytes were cultured and induced to differentiate by oleic acid in vitro.The levels of adiponectin and its receptors (AdipoR1 and AdipoR2) mRNA were measured by semiquantitative RT- PCR.The concentration of adiponectin in the culture medium was assayed by ELISA.The results showed that rhIL- 6 could inhibit adiponectin,AdipoR1 mRNA expressions and adiponectin secretion in SW872 adipocytes in a time- and dose-dependent manner,but did not influence adipoR2 mRNA expression.

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.