The intersection of CRFs and scheduled visits in a two-dimensional matrix in this template shows which CRFs are instantiated per visit. A forms schedule template is used to define case report form (CRF) usage over scheduled visits in a longitudinal study. Study designers conduct a design process using Microsoft Excel templates to define the study schema. ConnEDCt’s features, quality, and safety are reliable compared with existing guidelines and requirements, including Good Clinical Data Management Practices, the Food and Drug Administration (FDA), and Title 21 Code of Federal Regulations (CFR) Part 21. One tool is therefore easily deployed on iPads and laptops, which are our primary computing devices. FileMaker Pro Advanced provided the important advantages of rapid development and the ability to deploy cross-platform on iOS, Mac, and Windows platforms. , a commercial, cross-platform, relational database platform. ConnEDCt is built with FileMaker Pro Advanced by Claris International Inc. The main components of ConnEDCt are a client-side database, a cloud-based database server, a data synchronization engine, iOS mobile devices, and laptop personal computers. Web-based designer, offline data dictionary file on Microsoft Word, ExcelĮxcel-based form creation (XLSForm), drag-and-drop form creation (ODK Build)ĬonnEDCt consists of a distributed database, data entry interfaces, data management interfaces, scripted business rules, data synchronization, and data security features. Security of third-party libraries are not vetted, require user’s security staff to review libraries and source code on GitHubĮncrypted form security only transmissions over a secure HTTPS j connection are obscured from observers and prevent tampering in transmissionĮxcel, can be customized per user requirementĮxport to CSV k, JSON l (text only), KML m (for mapping applications)Ĭreate using FileMaker software on laptop interface use Excel to record variable lists methods adaptable per user’s comfort level HIPAA, Part 11, FISMA i standards (low, medium, or high), GDPR, depending on environmentīest practice security, Title 21 CFR Part 11 compliant, industry regulations, HIPAA compliant, data privacy technology Regulatory-compliant security and encryption Study protocol enforcement for scheduled and unscheduled encountersĬonditional CRFs e based on midline serial sampling or other criteria ODK Aggregate app, ODK Briefcase app, ODK Central app XML documents created using ODK JavaRosa library/any laptop Web server, database server, SMTP email server, fileserver (optional) on any laptop Web server, database server, SMTP d email server, file server (optional) on any laptop REDCap Cloud mobile app on iPhone, iPad, Android REDCap mobile app M圜ap on iPhone, iPad, Android Must submit new license to obtain a new REDCap system per each group of usersįee-based hosting by a third-party company Join REDCap Consortium, license agreement with Vanderbilt University. Nonprofit organization with sufficient IT c infrastructure. To address this, we felt that we had the correct clinical and technical team in place to build our own EDC tools to solve our needs and potentially those of a large community of researchers in the future. Other packages identified did not provide the required features specific to our study protocols, such as our strict data security specifications (compared with Open Data Kit ). In surveying EDC packages currently available on the market ( Table 1), some had to be ruled out completely because of the unreliable internet coverage in areas we focused on for our studies (compared with Research Electronic Data Capture, which had not yet released its mobile app when our initial research projects were being conducted in 2013 ). With several research projects on our roadmap that would be deployed in remote, international regions with complex longitudinal protocols, strict eligibility requirements, and distributed research teams, we aimed to use EDC over paper-based data capture to enforce our study protocols and provide better data security, data validation, and have instant access to data. Noting the benefits of electronic data capture (EDC) over paper-based data capture, beginning in 2012, we searched for an EDC tool for our research projects on human health and were unable to find a package that met our needs. Our research on human nutrition and global health spans multiple countries, encompasses both interventional and observational study designs, and requires secure data collection and management.
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