ABSTRACT
Objective: To introduce how to build a data platform of data collection and data management for multi-center birth cohort study by using REDCap. Methods: After the REDCap electronic data capture system was installed and set up, the electronic case report forms (eCRFs) were programmed to collect data in multi-centers. The rules of data quality control were programmed, and different levels of user right for access to data platform were assigned to the data managers and data clerks based on their role in research project. Results: With REDCap system being installed, the example project was created, and a series of eCRFs were established for each stage of preconception, pregnancy and childhood through follow-up. After intensive testing to improve and achieve a stable data platform, standardized trainings were provided to data-related team. The REDCap eCRFs were then put in use online. By assigning different user right of access to data platform, data entry can be from multi- research centers and survey sites. This REDCap data platform supported the cohort project on data collection and data management. Conclusion: The data platform established by using REDCap provides strong support to birth cohorts on data collection and data management. This example project of data platform can be applied to other epidemiological studies.
ABSTRACT
A fusion gene CTB-PROIN, in which Proinsulin gene was fused to the 3' end of CTB gene by a hinge peptide 'GPGP', was constructed and cloned into pET-30a(+) to obtain a prokaryotic expression vector pETCPI. Subsequently the recombinant plasmid pETCPI was transformed into E. coli stain BL21 (DE3). After induced by IPTG, the expression product was analyzed by sodium dodecyl sulphate-polyacrylamide gel (15%) electrophoresis (SDS-PAGE), and its result indicated that the recombinant protein CTB-PROIN was expressed and accumulated as inclusion bodies. The recombinant CTB-PROIN protein accumulated to the level of 25% of total bacterial proteins. After inclusion bodies was denaturalized and refolded in vitro, significant assembly of monomers had occurred, and the recombinant protein represented assembled pentamers. The results of western blotting analysis also demonstrated that the fusion protein could be recognized by the anti-CT and anti-insulin antibody, respectively. In addition, the result of the CTB-PROIN-GM1 binding assay, that the protein could bind to monosialoganglioside specifically, showed it possesed biological activity in vitro. These results provided the possibility of developing a cheaper and more efficient oral vaccine for type I diabetes using such constructs.