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T. Strasser, G. Lotz, E. Troeger, C. Zrenner, T. Peters, B. Wilhelm, E. Zrenner, R. Wilke; An Integrated System for Workflow and Data Management in Clinical Trials. Invest. Ophthalmol. Vis. Sci. 2008;49(13):5216. doi: https://doi.org/.
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Clinical trials demand a high degree of standardization and documentation of workflows, procedures, and reporting of patient related data. All information must be available in appropriate detail at any given time to different persons including investigator, monitor, sponsor, and regulatory authorities. We developed a software system capable of workflow and data management for clinical trials.
The open source document management system (DMS) Nuxeo was used as core technology to build the system. It facilitates the definition of workflows, detailed right- and role-management, versioning of documents, and an audit trail of all actions in the system. A web based user interface renders collaboration easy. The user interface was extended using XFORMS and ODM to implement a full featured eCRF system, which stores the content as documents inside the DMS. This allows for the integration of CRF- and source data in complex workflows, enabling features like manual cross-validation and automatic pre-validation of the entered content. The system creates a relation between eCRFs and source data and stores both in a central repository allowing continuous backup and monitoring. In that way, the entire study protocol and SOPs of a study can be implemented electronically. The system is based upon common standards like JEE, JSR 170, XML, and ODM and complies with legal constraints like FDA part 11, HIPAA and SOX.
The system has been adapted to manage workflow and document lifecycle within our ERG reading center. It manages data transfer from associated partners worldwide and provides automated real-time validation of incoming data. Using a web based interface for data transfer avoids the use of unsecure and undocumented communication via Email. Together, with an automated messaging system using RSS feed and mobile messaging, this enables short response times of the overall system. All processes and document flows are documented in the system and promote a smooth workflow. This system is being used in an international multicenter pharmacological trial.
The system allows for the integrative management of study related data, including eCRF, source data, SOPs, protocols and the management of workflow like central reading or monitoring. Automated data transmission renders double data entry dispensable; automated data validation and notification systems supports a time effective study management. All information about a clinical trial can be accessed via the web at one central system at any given time.
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