Establishment of the data capture and management platform for case-control study on precocious puberty based on REDCap system / 西安交通大学学报(医学版)

【Objective】 To conduct a case-control study on precocious puberty as an example to introduce the establishment and design of the electronic Data capture and management platform using Research Electronic data Capture (REDCap) system and support the development of clinical research. 【Methods】 Based on the clinical REDCap system, the case-control research project of precocious puberty was created, the case report forms were designed, the user rights were set, and the data quality control rules were formulated. 【Results】 We established the electronic data capture and management platform for our research, which had 15 case report forms, to collect the data of the participants, including sociodemographic information, time for rest and activities, diet, exposure to environmental internal-secretion interfering-substances, physical examination and biochemical indicators. We conducted project management by setting up features such as user permissions and workgroups, and added data quality verification rules to control data quality. The data could be exported in various file formats for analysis and sharing. 【Conclusion】 The application of REDCap to establish the data capture and management platform of precocious puberty case-control study has promoted the efficient implementation of clinical research, which can be further popularized and applied to clinical researches in other fields.

Application of REDCap system in clinical study follow-up process management / 中华医学科研管理杂志

Objective:To summarize the experiences of clinical study project management in Peking University Clinical Research Institute, REDCap (Research Electronic Data Capture) data management system was proposed to improve the follow-up process management.Methods:Current clinical study follow-up process management situation were analyzed and methods for utilizing REDCap in follow-up management was proposed.Results:Using REDCap through " direct management" and " system management" data management can improve the follow-up quality and standard level of management in clinical study, at the same time, secured better protection of participants′ privacy and rights during the process.Conclusions:REDCap plays crucial roles in securing follow-up data quality from the source, timely tracking and standardization of follow-up management, it can be adopted more widely in assisting clinical study follow-up management.

Application of research electronic data capture in an interactive online survey system for monitoring hypertension risk factors during pregnancy / 西安交通大学学报(医学版)

Objective To establish interactive online survey system for monitoring hypertension risk factors during pregnancy using the research electronic data capture (REDCap) system. Methods Based on the actual requirements of monitoring hypertension risk factors during pregnancy, an interactive online survey system was designed using the REDCap clinical research data collection system provided by the Open Research Data Platform of Xi'an Jiaotong University. Then, the online designer, data dictionary, branch logic, calculated fields and other module functions were used to create variables and set logical jumps to implement the questionnaire tool form creation. Finally, project management functions such as user rights and permission modules and group management, adding data quality verification rules, were applied to implement the implementation of quality control of survey data. Results The design of the above-mentioned survey system was achieved and put into clinical use according to the predetermined goals, and good feedback and high evaluation were received from researchers. Conclusion Application of research electronic data capture in an interactive online survey system for monitoring hypertension risk factors during pregnancy that was accompanied by friendly interface, convenient access, secure data storage, complete investigation functions, perfect quality control, and easy follow-up management and maintenance, providing a convenient, efficient, secure and standardized data management tool for medical researchers to conduct relevant research.

Use of REDCap in data collection and data management of birth cohort study / 上海交通大学学报（医学版）

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.

Research Electronic Data Capture (REDCap) electronic Informed Consent Form (eICF) is compliant and feasible in a clinical research setting.

Background: Electronic consent for research has shown success in clinical trial models, but has not been rigorously evaluated as an alternative to conventional paper consent. We sought to design a 21 CFR Part 11 compliant iPad-based electronic Informed Consent Form (eICF) with Research Electronic Data Capture (REDCap). As a secondary aim, we sought to compare subject workload between eICF and paper consent groups. Methods: This is a prospective, randomized study of subjects who completed an iPad-based eICF versus paper consent for research. The eICF was designed with REDCap and presented on an iPad. Subject workload was measured with the NASA Task Load Index (NASA-TLX) and subjective feedback in regards to consent process was collected. Results: A total of 116 subjects were screened for consent. Of which, 51 (44%) subjects provided informed consent and completed all study related procedures. Twenty-five (49%) eICF and 26 (51%) paper consents were completed. The eICF group rated a significantly greater preference to use the eICF for future research studies (6.4±1.5) compared to the paper consent group (5.0±1.9), p<0.01. There were no significant differences in NASA-TLX Weighted Scale or Total-TLX Scores between groups. One error resulted in the eICF group due to an inadvertent submission by a single subject. Conclusion: In summary, we have demonstrated that an iPad-based eICF designed with REDCap is both 21 CFR Part 11 compliant and feasible in the clinical research setting. The eICF does not appear to be more technically difficult or demanding than conventional paper consent.