Medical research is being increasingly conducted in networks of ever-larger research alliances. In order to make this possible, MediConnect® Research®, in combination with MediConnect®, provides the necessary structured data acquisition as well as the opportunity to exchange data in compliance with applicable data protection laws.
The basic module ensures the management, processing, and storage of personal data in the research context, taking into account the requirements of the European General Data Protection Regulation (GDPR). The identity management module is divided into two functional components, the interaction of which is carefully balanced, i.e., the patient list and the pseudonymization service. The personal identification of the patient is only possible for those directly involved in the treatment or for those involved in the communication and contacting of study participants.
This module serves the secure implementation and administration of individual and clearly delimited clinical study projects. In each case, the focus is on an explicitly formulated clinical research question. The purpose and duration of data storage within the system are defined accordingly. The module provides pseudonymized access to patient data via the basic module “Identification and Participation Management” if authorization is required.
The aim of the MediConnect® Research® database “Clinical Data” is to derive and provide research data from normal treatment events, primarily without additional intervention for research purposes. The MediConnect® “Clinical Documentation System”, in conjunction with the scientific database and the basic module for identification and participation management, provides a mechanism that largely integrates the collection of the required data in the treatment process and transfers it to the scientific database for further processing for research purposes.
The “Biosignals” research database serves the same purpose and is subject to the same requirements as the “Clinical Data” research database. However, it only stores biosignals of all kinds, e.g., ECG curves, blood pressure curves, and respiratory signals. Due to the efficient data acquisition during daily operation and mass storage of these biosignals, which are characterized as complex, MediConnect® enables the development of new, innovative processing algorithms by providing the information in a database.
The “Biosample Storage” module is used to collect and manage biomaterials (samples and materials obtained from them) for research purposes, in particular for research into the molecular genetic aspects of a disease, such as questions of genetic epidemiology. An integrative interaction with the Research® Basic Module for identification and participation management enables you to manage samples both effectively and securely.
The “Biosample Annotations” clinical database is particularly useful when researching diseases that are so rare or the treatment of which is so complex that it cannot be handled by individual regular care centers. MediConnect® Research® largely integrates the collection and processing of data in the treatment process, taking into account data protection and communication with external specialized centers. In interaction with the MediConnect “Biosample Storage” module and the basic module “Identification and Participation Management”, the system provides a mechanism that ensures the required data are collected in the “Biosample Annotations” database for findings and research and integrates the relevant findings in the MediConnect “Clinical Documentation System” treatment process.