Source data and its source documents are the foundation of clinical research. Proper source data management plays an essential role for compliance with regulatory and GCP requirements. Both paper and electronic source data co-exist in China. Due to the increasing use of electronic technology in pharmaceutical and health care industry, electronic data source becomes an upcoming trend with clear advantages. To face new opportunities and to ensure data integrity, quality and traceability from source data to regulatory submission, this document demonstrates important concepts, principles and best practices during managing source data. It includes but not limited to: (1) important concepts of source data (e.g., source data originator, source data elements, source data identifier for audit trail, etc.); (2) various modalities of source data collection in paper and electronic methods (e.g., paper CRF, EDC, Patient Report Outcomes/eCOA, etc.); (3) seven main principles recommended in the aspect of data collection, traceability, quality standards, access control, quality control, certified copy and security during source data management; (4) a life cycle from source data creation to obsolete is used as an example to illustrate consideration and implementation of source data management.
China ; Data Collection ; standards ; Documentation ; standards ; Information Storage and Retrieval ; methods ; standards

Characteristics and measurement principles of reference methods in clinical biochemistry were described.Implementation of reference systems is one of the most effective approaches to improve the accuracy and comparability of clinical laboratory test results.Reference methods are the key components of reference systems.Reference methods should have measurement uncertainties that meet the requirements of the intended use,and thus should be based on reliable measurement principles.For the well-defined biochemistry analytes,reference methods have been almost all based on instrumental analysis.Isotope dilution mass spectrometry (ID/MS) is considered most reliable and has been the major analytical principle of the reference methods.ID/MS analysis is accurate but expensive.Use of other validated instrumental analyses as reference measurement principles would be justified.

T were also detected in the controls.Conclusion Nephrotic syndrome may be associated with NPHS2 identified in children.

Ultrasound contrast agent microbubbles combined with low frequency ultrasound named as low-frequency ultrasound-targeted microbubble destruction technology has become an effective and non-invasive anti-tumor therapy for deep tumors.It can enhance the efficacies of chemotherapy,gene therapy,immunotherapy,and anti-angiogenic therapy by improving cell membrane permeability and destroying tumor neovasculature.It can be applied to sonodynamic therapy and realize multimodal synergistic therapy on the basis of nanoparticles,which increases the anti-tumor efficiency and offers a promising target therapy for tumors.
Contrast Media ; Genetic Therapy ; Humans ; Microbubbles ; Neoplasms ; Ultrasonography

0.05).Setting the threshold of MOV at 6.4 cm~3 offered the best compromise between sensitivity (84.8%)and specificity(87.5%),and setting the threshold of MaxOV at 8.6 cm~3 offered the best compromise between sensitivity(75.8%)and specificity(95.2%)and setting the threshold of MFN at 8 offered the best compromise between sensitivity(86.7%)and specificity(78.3%).Conclusions Ovarian morphology by ultrasonography yields satisfactory diagnostic accuracy for adolescent PCOS.Taking MOV≥ 6.4 cm~3 or MaxOV≥8.6 cm~3 or MFN≥8 as an ultraphonic criterion for pubertal PCOS offer the best compromise between sensitivity and specificity.

To study the relation between drug release and the drug status within curcumin-loaded microsphere, SPG (shirasu porous glass) membrane emulsification was used to prepare the curcumin-PLGA (polylactic-co-glycolic acid) microspheres with three levels of drug loading respectively, and the in vitro release was studied with high-performance liquid chromatography (HPLC). The morphology of microspheres was observed with scanning electron microscopy (SEM), and the drug status was studied with X-ray diffraction (XRD), differential scanning calorimetry (DSC) and infrared analysis (IR). The drug loading of microspheres was (5.85 ± 0.21)%, (11.71 ± 0.39)%, (15.41 ± 0.40)%, respectively. No chemical connection was found between curcumin and PLGA. According to the results of XRD, curcumin dispersed in PLGA as amorphous form within the microspheres of the lowest drug loading, while (2.12 ± 0.64)% and (5.66 ± 0.07)% curcumin crystals was detected in the other two kinds of microspheres, respectively, indicating that the drug status was different within three kinds of microspheres. In the data analysis, we found that PLGA had a limited capacity of dissolving curcumin. When the drug loading exceeded the limit, the excess curcumin would exist in the form of crystals in microspheres independently. Meanwhile, this factor contributes to the difference in drug release behavior of the three groups of microspheres.
Calorimetry, Differential Scanning ; Curcumin ; chemistry ; Drug Liberation ; Lactic Acid ; Microscopy, Electron, Scanning ; Microspheres ; Polyglycolic Acid ; X-Ray Diffraction

Objective To investigate the drug resistance genes of extended-spectrum beta- lactamase-producing bacteria in 49 strains.Methods Extended-spectrum ?-lactamase -producing strains were detected by the disc diffusion test.The techniques of polymerase chain reaction,sequence analysis, pulsed-field gel electrophoresis were used to analyze the genotype and homology of extended-spectrum ?- lactamase-producing strains.Results The incidence of ESBL-producing strains from E.coli,K pneumoniae,K oxytoca,was 20% in 2000,and 40% in 2003.Among the 49 ESBLs producers the most common genotype was CTX-M-14( n=33).The others were CTX-M-3,CTX-M-9,CTX-M-12,CTX-M-15, CTX-M-24 and SHVSa.Both two CTX-M subtypes,CTX-M-3 and CTX-M-14,were detected in one strain. However,4 ESBL-producing strains confirmed by phenotype remained untyped.The results showed that the ESBLs producers were not closely related,except for two strains of E.coli and two strains of K.pneumoniae which were homgenic respectively.Concolusions The incidence of ESBL-producing strains increases with years.The most common genotype of ESBLs is CTX-M.There is no evidence for epidemiologic spread of ESBL-producers by pulsed-field gel electrophoresis.

Objective To study the osteogenic effects of induced endothelial cell(EC)on bone marrow stromal cells(BMSCs)of rabbits in co-culture condition.Methods BMSCs were obtained from rabbits by density gradient centrifugation.The adhesive ceils were preserved to passage in culture.The cultured cells were divided into four groups:group A(BMSCs),group B(BMSCs osteogenic induction),group C(EC induction)and group D (co-culture of induced BMSCs and EC).The cell morphology,immunofluorescence,cell proliferation,alkaline pbosphatase(ALP)activity,osteocalcin synthesis were observed to determine the effects of induced autologous EC on the osteogenic potential and cellular compatibility of BMSCs.Results The immunochemical staining showed that the BMSCs were induced into EC in group C.The cellular compatibility of BMSCs and EC was good.The ALP activity and osteocalcin content were obviously higher in group D than in any other groups(P＜0.05).The cell proliferation difference was not obvious between groups(P＞0.05).Conclusions The cellular compatibility of induced osteoblasts and induced EC is perfect.The ECs can significantly increase the viability and ALP activity of induced osteoblasts.

Zwittermicin A was purified by ion exchange resin and HPLC from supernatants of Bacillus thuringiensis.subsp.kurstaki strain D1-23 cultivation.2.89mg pure Zwittermicin A was acquired,proved by HPLC-MS.Results show that the optimized wash concentration of NH_ 4 H_ 2 PO_ 4 is 5mmol/L at first step.Next step CH_ 3 COONH_ 4 concentration is 30 mmol/L,the gradient pH is 8.0～9.5.Totally 93% Zwittermicin A can be reserved with ion exchange resin.The temperature and pH stability experiments show the half life of Zwittermicin A is 48.22 minutes in 100℃,and it is more stable in lower pH in pH 2.0～12.0.

Objective To investigate the dose- and time-effects of astragaloside Ⅳ(XGA) on collagen of myocardial fibroblasts in rats.Methods The myocardial fibroblasts of rats were separated by collagenase and trypsinase digestive method,and the cell culture system was established. After XGA in different concentrations and at different time points was administered in fibroblast culture systems,the mRNA expression levels of collagen,matrix metalloproteinases(MMP)-1,-2,-9,tissue inhibitor of metalloproteinase(TIMP)-1 and -2 were measured with reverse transcription-polymerase chain reaction(RT-PCR) test.Results After XGA administration with different doses and at different time points was adminstered,the gel electrophoresis product of RT-PCR in fibroblast culture system expressed the mRNA of type Ⅰ,Ⅲ and Ⅳ collagens,MMP-1,-2,-9,TIMP-1 and -2;but the mRNA expression levels of type Ⅰ,Ⅲ and Ⅳ collagens,TIMP-1 and -2 decreased and the mRNA expression levels of MMP-1,-2,and -9 increased compared to those before XGA administration;the mRNA expression of type Ⅰ,Ⅲ and Ⅳ collagens,MMP-1,-2,-9,TIMP-1 and -2 decreased or increased gradually with the increase of doses and the prolonged time of XGA use.The mRNA expression levels of type Ⅰ,Ⅲ and Ⅳ collagens,TIMP-1 and -2 were negatively related to the doses and action times of XGA(r=-0.927 to -0.637 P= 0 to 0.024);and the mRNA expression levels of MMP-1,-2 and -9 were positively related to the doses and action times of XGA(r=0.672 to 0.962 P=0 to 0.034).Conclusion XGA can markedly reduce the collagen formation of myocardial fibroblasts in rats,and its mechanisms are related to the inhibiting of collagen synthesis and the increase of collagen degradation.