Case report form (CRF) is a key document for data collection in clinical trials. A well-designed CRF is required for database construction, data accuracy, data query/cleaning, CRF completion and statistical analysis. A well-defined process or SOP should be in place for CRF design. Data collection should fully meet the demand of study protocol. The layout of CRF should be clear with well-structured fields and standard coding for fields.

There is no a systemic performance metrics for clinical data management. While the CDMC in China starts to develop the quality metrics for clinical data management, it is essential to think over the performance and pursue metrics implementation of clinical data management in China. This article provides the basic concept, development and implementation of the performance metric in clinical data management.

Objective To investigate the association between HLA classⅡgenes and bullous pem-phigoid(BP).Methods HLA-DRB1,DQA1,DQB1were determined by polymerase chain reaction se-quence specific oligonucleotide probe methods in56patients with BP and150normal controls from Shanghai area.Results It was shown that HLA-DRB1*10(*1001)was linked to DQB1*0501,and its frequency in-creased significantly in BP group compared to normal controls.There was a positive correlation between DRB1*1001and mucosal involvememt as well as autoantigen BP230.HLA-DRB1*04was linked to DQB1*0302,and its frequency increased significantly in BP group compared with normal control.There was a positive correlaton between DRB1*04and autoantigen BP180.The frequency of HLA-DRB1*12(*1201,*1202)decreased in BP group compared to normal controls.Conclusions It is suggested that HLA-DRB1*1001and DRB1*04be the susceptible genes while DRB1*1201,and*1202be the protective genes of BP patients in Shanghai area.

Objective To investigate hepatitis B virus mutation rate after the universal immunization in China. Methods DNA sequence analysis of the “a” determinant was performed on sera from 72 viral carrier children after immunoprophylaxis selected through a sampling survery. Results Four mutants were detected, the mutation rate was 5.56%. One strain showed Gly-to-Arg mutation at the 145 codon of surface antigen. Animo acid substitutions at the amino acid 126 and 140 were noted in the other three children. The epidemiological HBV serotype shifted from previous adw infection to more recent adr was also observed. Conclusions These observations indicate that vaccination is probably the cause of mutation, whereas the mutation is low and it will certainly not be a reason for doubting that the vaccination is the method of main choice for preventing hepatitis B infection that still devastates the developing countries.

Objective To analyze the diagnosis and therapy of pemphigus and pemphigoid.Methods Clinical data were retrospectively analysed for 648 patients with pemphigus or pemphigoid admitted in Huashan Hospital,Fudan University from 2003 to 2007.Results The mean age of onset of pemphigus was younger than that of pemphigoid(47.0±16.9 years vs 65.1±13.9 years.P＜0.001).Of 175 patients with pemphigus confirmed by direct immunoflorescence(DIF),100%were positive for IgG,and 92.0%for C3,while out of 223 patients with pemphigoid,51.12%were positive for IgG,99.1%for C3.For pemphigus,the consistency reached 68.8%among clinical diagnosis.pathological diagnosis and immunological(DIF)diagnosis,80.7%between pathological and immunological diagnosis.In the case of pemphigoid,the consistency was 62.8%among clinical,pathological and immunological diagnosis,and 78.1%between pathological and immunological diagnosis.Corticosteroids were primary treatment strategy for both pemphigus and pemphigoid.and prednisone of 0.5-1.5 mg per kilogram bodyweight per day could control the condition of most patients.Conclusions DIF could be used as an important diagnostic means for patients with pemphigus or pemphigoid which can not be confirmed by clinical manifestation or pathology.In primary hospitals,IgG and C3 are recommended for DIF testing when pemphigus is suspected,and C3 is recommended for suspected pemphigoid.

Objective To observe the effect of transforming growth factor-β1 (TGF-β1) vaccine on the degree of hepatic fibrosis in rats ,and to explore the effect of TGF-β1 vaccine on the insulin-like growth factor binding protein (IGFBP)3 and IGFBP7 .Methods The hepatic fibrosis rat model was set up by injecting N-nitrosodimethylamine . Among them , 10 rats were injected with TGF-β1 vaccine , and additional 10 rats were set up as healthy control group .Changes in hepatic pathology were observe and the expressions of IGFBP3 and IGFBP7 were detected by the methods of immunohistochemistry , reverse transcription polymerase chain reaction (RT-PCR) and Western blot in rat fibrosis tissues after 6 weeks . Normality test and analysis of variance were conducted .LSD test was conducted if variances were tested homogeneity .Categorical data were analyzed using Fisher exact test . Results Changes in hepatic histology and serum levels of hyaluronic acid and laminin suggested that TGF-β1 vaccine interventions could reduce the extent of hepatic fibrosis in rats .The expressions of IGFBP3 mRNA in control group ,hepatic fibrosis model group and vaccine intervention group were 1 .735 ± 0 .097 ,1 .165 ± 0 .096 and 1 .491 ± 0 .046 ,respectively (t= 4 .575 ,6 .285 and 8 .489 ,respectively ,all P< 0 .05) .The expressions of IGFBP7 in the above three groups were 0 .497 ± 0 .021 ,1 .250 ± 0 .064 and 0 .885 ± 0 .149 ,respectively (t= 5 .161 ,30 .101 and 7 .250 , respectively ,all P < 0 .05 ) . Immunohistochemistry proved that the expressions of IGFBP7 in fibrosis model group and TGF-β1 vaccine group were all significantly higher than control group ;and the expressions of IGFBP3 in fibrosis model group and TGF-β1 vaccine group were all significantly lower than control group .The expressions of IGFBP3 protein in control group , hepatic fibrosis model group and vaccine intervention group were 7 .508 ± 0 .357 ,5 .200 ± 0 .210 and 5 .751 ± 0 .178 ,respectively (t = 7 .622 ,6 .180 and 29 .156 , respectively ,all P < 0 .05) . The expressions of IGFBP7 were 1 .176 ± 0 .051 ,1 .735 ± 0 .115 and 1 .428 ± 0 .056 ,respectively (t = 7 .188 ,4 .827 and 8 .649 ,respectively ,all P< 0 .05) .Conclusion TGF-β1 vaccine can affect the expressions of IGFBP3 and IGFBP7 ,which plays an important role in the formation and development of hepatic fibrosis .

Visceral leishmaniasis (VL) is a parasitic disease ,which is still endemic in western China .An earthquake struck south-western China on May 12th ,2008 ,which affected Longnan City of Gansu Province considerably .The objective of this survey is to determine the effect of the Wenchuan earthquake on the Kala-azar epidemic in Longnan City .In this study ,VL cases were collected from 2005 to 2013 and diagnosed on positive test for anti-rK39IgG antibodies by the Kala-azar Detect rK39 dip-stick (InBios ,USA) .The incidence rates were calculated among various counties of Longnan City with SPSS 19 .0 soft-ware .The epidemiological characteristics of the disease were analyzed before and after the Wenchuan earthquake .From 2005 to 2013 ,there were 825 VL cases in Longnan City ,with an annual incidence of 3 .36/100 000 and a significantly higher incidence in males than that in females (P＜ 0 .001) .All age groups were affected .During this period ,there was an obvious upward trend from 2005 to 2008 ,and a distinct downward tendency since 2010 .The incidences of VL between 2008 and 2010 were sig-nificantly different with that in other years (P＜0 .01) .Results revealed that VL was widespread in Longnan City ,which was likely exacerbated by the earthquake in 2008 .Earthquake created diverse natural environment and social circumstances ,w hich may contribute to the spread of the VL epidemic .Together ,our data strongly suggest that the epidemic of VL should be close-ly monitored after earthquake .

Establishment of quality management system (QMS) plays a critical role in the clinical data management (CDM). The objectives of CDM are to ensure the quality and integrity of the trial data. Thus, every stage or element that may impact the quality outcomes of clinical studies should be in the controlled manner, which is referred to the full life cycle of CDM associated with the data collection, handling and statistical analysis of trial data. Based on the QMS, this paper provides consensus on how to develop a compliant clinical data management plan (CDMP). According to the essential requirements of the CDM, the CDMP should encompass each process of data collection, data capture and cleaning, medical coding, data verification and reconciliation, database monitoring and management, external data transmission and integration, data documentation and data quality assurance and so on. Creating and following up data management plan in each designed data management steps, dynamically record systems used, actions taken, parties involved will build and confirm regulated data management processes, standard operational procedures and effective quality metrics in all data management activities. CDMP is one of most important data management documents that is the solid foundation for clinical data quality.

Objective To probe the Th cytokine pattern in pemphigus,so as to clarify the pathogenesis of pemphigus and draw up new therapy.Methods Reverse transcription-polymerase chain reaction(RT-PCR)was used to examine the interferon gamma(IFN-?)and interleukin10(IL-10)mRNA expression on peripheral blood mononuclear cells(PBMCs)of20cases of pemphigus in acute stage,20cases in stable stage,and20normal controls.Results The IFN-?mRNA expression in20cases of pemphigus in acute stage was higher than that of controls(P