Study center, telematics and information service - Project description
Background
One significant prerequisite for the implementation of high-quality studies in the network is the establishment of a uniform, standardized process quality for project planning, implementation and analysis for all partners as well as for documentation and material flow. Beyond that there is a great need to make information and data available to all partners in an efficient, timely manner. At the same time, electronic storage and transmission of medical data requires great care with regard to data protection and privacy. As an instrument of communication, procurement and increasingly for the publication of specialist information, the Internet has become the most important medium.
Objective
With the development of the Center for Study Coordination, Study Management and Biometrics (CSSB), structures for the implementation of large-scale, internationally competitive scientific studies are now available to the Heart Failure Competence Network. The studies are carried out with uniform quality standards at all participating partner institutes and meet the highest biometric, documentary and data protection criteria. The central database structures must be continuously maintained, evaluated and expanded. New requirements for data protection and secure data exchange necessitate ongoing evaluation and adaptation of the implemented concepts.
Implementation
In order to achieve uniform process and documentation quality, the CSSB is responsible for the harmonization of the documentation content of all research projects, the formulation of standard operating procedures (SOPs), support in the preparation of study protocols and case report forms (CRFs), the implementation of monitoring processes to ensure quality control and the coordination of data and material flows. To ensure biostatistical quality, the CSSB provides support to all projects during the planning, implementation and analyses of the studies.
The CSSB develops and implements the entire information technology and telematics infrastructure required throughout the network. It installs and operates an online database system for recording all of the study data collected with an integrated three-level monitoring process for quality control of the data capture. A comprehensive plan for data protection and secure data exchange is integrated in the database design. Among other things, this includes encrypted data transmission, a firewall system and pseudonymization of the medical data, during which these are separated from the personal data in clear text. For the operation of the internet portal, a state-of-the-art content management system (CMS) is used for the generation, structured filing, distribution and targeted retrieval of information. This enables the collaborating partners to publish contents in a timely manner and to classify documents without special programming knowledge. The CSSB also functions as a training center for all partners in the competence network. Various courses on documentation, logistical processes and project-specific data processing systems are held.