Data Integration Center
ManagementScientific Management
Prof. Dr. Kurt Marquardt University Hospital Giessen-Marburg, Site Giessen Klinikstraße 36 35392 Gießen |
Technical Management & Contact InformationTechnical Management |
Description
The Giessen Data Integration Center (DIC) grants researchers secure access to approved research and routine care data from the University Hospital and Justus Liebig University Giessen. The center places heavy emphasis on data protection and security. Faculty 11 Medicine at Justus Liebig University Giessen and the UKGM / Giessen site operate the DIC Giessen, whilst the Institute of Medical Informatics at Justus Liebig University Giessen manages staffing and structure.
As part of the Medical Informatics Initiative (MII) by the Federal Ministry of Research, Technology and Space (BMFTR), the German MII consortia are establishing data integration centers (DICs). At the Institute of Medical Informatics, Justus Liebig University Giessen, in partnership with the Geschäftsbereich IT (GB IT) at Giessen University Hospital, the DIC Giessen is currently under development. The data integration centers play a central role in current and future research activities with patient data at university hospitals. While data consolidation, analysis, and Extract-Transform-Load (ETL) routes require coordination within the MII network, local service options should not be overlooked. Thus, these centers must offer their services in research projects locally as a service instance rather than solely focusing on MII orientation. The DICs provide project administration, implementation, and broad consent requirements services. They offer a consistently regulated process structure and utilize tools to establish infrastructural and semantic interoperability, which allows them to create databases with the FHIR standard. This enables a wide range of data to be utilized for various project needs. The pre-DIC, the data platform of the DIC, functions as a standard framework for different data uses.
Instrumentation/Software
The DIC is composed of two main stages. The pre-DIC, which is situated in the area of routine care data, extracts research-specific data. This data is then anonymized and made accessible to researchers in various evaluation formats in the actual DIC data space that is under the supervision of the trusted third party (TTP). The actual DIC is located within the jurisdiction of the Giessen Research Network (GIFONET). The researcher accesses the data provided through the data integration platform (DIP). This web-based application presents all DIC tools to researchers in one interface.
Pre-DIC
The pre-DIC involves mirroring data from the Synedra universal clinical data archive and a structured FHIR data pool. A data repository has been established to integrate data from different source systems in a harmonized way, supporting data projects. It serves as a single point of contact for secondary use of data from routine clinical operations at UKGM Giessen.
All production clinical systems store their data in the HL7-FHIR standard format as information resources. The pre-DIC provides semantic enrichment to these resources using standard codes such as LOINC for laboratory data and SNOMED-CT for other clinical data. This enables cross-site research.
All production clinical systems store their data in the HL7-FHIR standard format as information resources. The pre-DIC provides semantic enrichment to these resources using standard codes such as LOINC for laboratory data and SNOMED-CT for other clinical data. This enables cross-site research.
Data export
To supply data for medical research studies, our in-house software extracts information from the pre-DIC system tailored to each project’s specifications. Patient groups are carefully selected for each research endeavor, such as only those with specific health conditions like heart failure, and the data to be evaluated, such as heart rate and procedures, are determined.
Data Integration Platform
The data integration platform (DIP) serves as a centralized tool hub for research teams by providing dedicated areas for study-related files and data storage. Access is restricted to authorized team members only. The DIP also offers various organizational and technical tools to support research project management.
Research Data Portal
In preparation for medical research projects, researchers utilize software to generate simple case number queries. The program allows the user to input clinical characteristics, such as age, gender, diagnoses, procedures, and laboratory parameters of the subject group being researched. Once the parameters are entered, the query can be initiated. The program then produces a list of all patients in the hospital who meet the search parameters. The resulting query can be used as a foundation for clinical studies.
ProSkive
The ProSkive software provides organizational support for a medical research project by creating applications for requesting collaboration with the DIC or data provision. The Use and Access Committee (UAC) can accept or reject these applications.
Research Data Portal
In preparation for medical research projects, researchers utilize software to generate simple case number queries. The program allows the user to input clinical characteristics, such as age, gender, diagnoses, procedures, and laboratory parameters of the subject group being researched. Once the parameters are entered, the query can be initiated. The program then produces a list of all patients in the hospital who meet the search parameters. The resulting query can be used as a foundation for clinical studies.
ProSkive
The ProSkive software provides organizational support for a medical research project by creating applications for requesting collaboration with the DIC or data provision. The Use and Access Committee (UAC) can accept or reject these applications.
Systems for Data analysis
Data requested by researchers can be provided in multiple formats. We provide comprehensive integration and tools for various data formats.
The simplest form of providing data is through Excel tables, which can be further processed by researchers individually. These tables are stored in the DIP for researchers.
Additionally, we will offer standardized data formats such as Observational Medical Outcomes Partnership (OMOP) as a database or within a FHIR server. Special analysis tools are available in both formats to be utilized as a tool within the DIP.
It is also possible to integrate the tools into a RedCap environment. Additionally, the DIC provides a RedCap server.
The simplest form of providing data is through Excel tables, which can be further processed by researchers individually. These tables are stored in the DIP for researchers.
Additionally, we will offer standardized data formats such as Observational Medical Outcomes Partnership (OMOP) as a database or within a FHIR server. Special analysis tools are available in both formats to be utilized as a tool within the DIP.
It is also possible to integrate the tools into a RedCap environment. Additionally, the DIC provides a RedCap server.
Services
Research Data Management
Consulting
The DIC serves as the main resource hub for researchers at the JLU Faculty of Medicine in Giessen. The research data management team offers guidance on data storage, integration methods within the central DIC structures, and all other aspects of the clinical research data landscape. Additionally, the staff serves as the primary point of contact for accessing DIC services and support.
Research Proposals
For future research or funding proposals, locations with a Data and Information Center (DIC) should utilize its existing infrastructure and expertise. DIC employees support the application process by discussing and developing necessary framework conditions for data management. Additionally, the creation of a data management plan is a crucial component and its core aspects, including long-term archiving, reliability, and data extraction scope, can be defined directly by DIC employees. Based on the necessary components and any software and hardware solutions provided by the DIC, the DIC can determine the cost breakdown for these aspects.
Digitization
Due to the rapid digitalization of the healthcare industry, it is crucial to utilize existing and potentially established solutions when incorporating digital processes. In this regard, DIC staff members offer assistance in identifying, analyzing, and implementing digital processes as well as providing subsequent support and validation in conjunction with the clinical department. Another aspect is process optimization, which is also an integral part of the DIC Research Data Management department.
Link to the DIC
To achieve interoperability, standardization, secure data exchange, and data analysis, research data needs to be integrated into the Data Integration Center. DIC experts guide clinical departments on technical aspects associated with connecting to the center and provide support until the desired research data is fully integrated.
Information security and data protection
Data protection and IT system security are vital in the medical field. The DIC advises researchers to ensure both aspects are up-to-date, enabling them to store data securely and in compliance with regulations. More information can be found in the DIC's data protection and IT security concept.
Data management according to FAIR principles
The research data life cycle must proceed uninterrupted and complete. To enable this, the FAIR principles set out four crucial components for the establishment of research infrastructure and data management. The principles of discoverability, accessibility, interoperability, and reusability are the foundation of the DIC in Gießen. DIC staff advises researchers on these principles and creates concepts to align existing research data with the FAIR principles.
The DIC serves as the main resource hub for researchers at the JLU Faculty of Medicine in Giessen. The research data management team offers guidance on data storage, integration methods within the central DIC structures, and all other aspects of the clinical research data landscape. Additionally, the staff serves as the primary point of contact for accessing DIC services and support.
Research Proposals
For future research or funding proposals, locations with a Data and Information Center (DIC) should utilize its existing infrastructure and expertise. DIC employees support the application process by discussing and developing necessary framework conditions for data management. Additionally, the creation of a data management plan is a crucial component and its core aspects, including long-term archiving, reliability, and data extraction scope, can be defined directly by DIC employees. Based on the necessary components and any software and hardware solutions provided by the DIC, the DIC can determine the cost breakdown for these aspects.
Digitization
Due to the rapid digitalization of the healthcare industry, it is crucial to utilize existing and potentially established solutions when incorporating digital processes. In this regard, DIC staff members offer assistance in identifying, analyzing, and implementing digital processes as well as providing subsequent support and validation in conjunction with the clinical department. Another aspect is process optimization, which is also an integral part of the DIC Research Data Management department.
Link to the DIC
To achieve interoperability, standardization, secure data exchange, and data analysis, research data needs to be integrated into the Data Integration Center. DIC experts guide clinical departments on technical aspects associated with connecting to the center and provide support until the desired research data is fully integrated.
Information security and data protection
Data protection and IT system security are vital in the medical field. The DIC advises researchers to ensure both aspects are up-to-date, enabling them to store data securely and in compliance with regulations. More information can be found in the DIC's data protection and IT security concept.
Data management according to FAIR principles
The research data life cycle must proceed uninterrupted and complete. To enable this, the FAIR principles set out four crucial components for the establishment of research infrastructure and data management. The principles of discoverability, accessibility, interoperability, and reusability are the foundation of the DIC in Gießen. DIC staff advises researchers on these principles and creates concepts to align existing research data with the FAIR principles.
Organizational core services
Data usage request
A data usage application is necessary for utilizing data from the DIC. DIC personnel provide researchers with guidance on the available options offered by the DIC from the start of the project and guide them through the entire application process until the desired data is received. Transparent explanation of the steps required for submitting an application, including involvement from committees like the Use & Access Committee, is always provided by the DIC.
Feasibility requests
Researchers utilizing DIC-operated systems can conduct feasibility analyses on the existing database at the outset of a research project. This allows for quick identification of potential study participants or areas for future study. DIC staff provide step-by-step assistance throughout the data usage application process.
Data usage agreement
To conduct research projects utilizing data extracts from the DIC, researchers must always enter into a data usage agreement, which is legally required and serves as a crucial component between the DIC and the researchers. Within the agreement, the DIC and the contact persons from both the DIC and the research department define the specific data for extraction, data format, and the necessary software solutions. The management of DIC supervises this process and begins the work of the DIC components and internal departments after the contract has been successfully executed.
A data usage application is necessary for utilizing data from the DIC. DIC personnel provide researchers with guidance on the available options offered by the DIC from the start of the project and guide them through the entire application process until the desired data is received. Transparent explanation of the steps required for submitting an application, including involvement from committees like the Use & Access Committee, is always provided by the DIC.
Feasibility requests
Researchers utilizing DIC-operated systems can conduct feasibility analyses on the existing database at the outset of a research project. This allows for quick identification of potential study participants or areas for future study. DIC staff provide step-by-step assistance throughout the data usage application process.
Data usage agreement
To conduct research projects utilizing data extracts from the DIC, researchers must always enter into a data usage agreement, which is legally required and serves as a crucial component between the DIC and the researchers. Within the agreement, the DIC and the contact persons from both the DIC and the research department define the specific data for extraction, data format, and the necessary software solutions. The management of DIC supervises this process and begins the work of the DIC components and internal departments after the contract has been successfully executed.
Transfer office
Data extraction
The DIC transfer office's primary task is to extract the data stipulated in the data use agreement from existing routine clinical systems and the research data warehouse within the DIC. The office places significant emphasis on ensuring data sets are pseudonymized.
Data provision
After the data is extracted by the transfer office, it will be made available through the designated systems according to the specifications and wishes of the researcher. Access restrictions and periods of access are determined by the data usage agreement.
Study recruitment
The DIC provides solutions for identifying potential study participants using routine clinical systems. Additionally, the DIC's research data management team offers advice on implementing automated identification, which requires a data usage agreement.
The DIC transfer office's primary task is to extract the data stipulated in the data use agreement from existing routine clinical systems and the research data warehouse within the DIC. The office places significant emphasis on ensuring data sets are pseudonymized.
Data provision
After the data is extracted by the transfer office, it will be made available through the designated systems according to the specifications and wishes of the researcher. Access restrictions and periods of access are determined by the data usage agreement.
Study recruitment
The DIC provides solutions for identifying potential study participants using routine clinical systems. Additionally, the DIC's research data management team offers advice on implementing automated identification, which requires a data usage agreement.
Data & Knowledge Management
Data processing and analysis
For data analysis and processing, the DIC creates algorithms in response to researchers' requests to programmatically support specific use cases. Due to the large and complex quantities of data, artificial intelligence and machine learning techniques and developments are employed. The DIC's Data & Knowledge Management sector informs researchers about data evaluation, processing and analysis. It is also involved in developing relevant contracts.
Medical statistics
If statistical questions arise during a research project conducted at DIC, the staff is available to direct researchers to the medical statistics working group at the Institute of Medical Informatics (IMI). Cooperation between both parties is crucial to successfully cover all aspects of the project. DIC staff provides support in the form of a designated contact person for the project.
Data integration
The integration of data from clinical subsystems into the structures of the DIC or research systems always requires the development of ETL (Extract-Transform-Load) routes. This involves recording the researchers' requirements, extracting the data programmatically, transforming it for the target and then loading it into the target base. The required routes are identified at the beginning of a research project by DIC's Research Data Management, documented by the researcher in the data usage contract, and implemented and tested by Data & Knowledge Management during the course of the project.
For data analysis and processing, the DIC creates algorithms in response to researchers' requests to programmatically support specific use cases. Due to the large and complex quantities of data, artificial intelligence and machine learning techniques and developments are employed. The DIC's Data & Knowledge Management sector informs researchers about data evaluation, processing and analysis. It is also involved in developing relevant contracts.
Medical statistics
If statistical questions arise during a research project conducted at DIC, the staff is available to direct researchers to the medical statistics working group at the Institute of Medical Informatics (IMI). Cooperation between both parties is crucial to successfully cover all aspects of the project. DIC staff provides support in the form of a designated contact person for the project.
Data integration
The integration of data from clinical subsystems into the structures of the DIC or research systems always requires the development of ETL (Extract-Transform-Load) routes. This involves recording the researchers' requirements, extracting the data programmatically, transforming it for the target and then loading it into the target base. The required routes are identified at the beginning of a research project by DIC's Research Data Management, documented by the researcher in the data usage contract, and implemented and tested by Data & Knowledge Management during the course of the project.
Data Integration Platform (DIP)
Data storage
The DIP is the user interface that provides researchers with direct access to the DIC system and data landscape. The focus of the DIP is on the management of the provided storage, the administration of datasets, the sharing of research data and the use of software solutions provided by the DIC. The DIC offers the possibility to purchase storage quotas on the platform to enable centralized, secure and web-based data storage.
Cross-departmental research workbench
Thanks to the DIP's complex system of roles and rights, entire research departments can be mapped within the platform in terms of personnel and assigned appropriate access rights. The DIC thus provides a research workbench that can be used by entire departments and also enables data sharing between departments.
Use-case specific modules
The module-based DIP not only provides integrated software solutions, but also supports in-house developments that are made available as modules within the platform. The DIC thus enables contract development by researchers to meet application-specific requirements for data input, processing or visualization.
The DIP is the user interface that provides researchers with direct access to the DIC system and data landscape. The focus of the DIP is on the management of the provided storage, the administration of datasets, the sharing of research data and the use of software solutions provided by the DIC. The DIC offers the possibility to purchase storage quotas on the platform to enable centralized, secure and web-based data storage.
Cross-departmental research workbench
Thanks to the DIP's complex system of roles and rights, entire research departments can be mapped within the platform in terms of personnel and assigned appropriate access rights. The DIC thus provides a research workbench that can be used by entire departments and also enables data sharing between departments.
Use-case specific modules
The module-based DIP not only provides integrated software solutions, but also supports in-house developments that are made available as modules within the platform. The DIC thus enables contract development by researchers to meet application-specific requirements for data input, processing or visualization.
Software solutions provided
EDC-Systems
As part of its digitization projects, the DIC Giessen has developed a system for capturing questionnaires used in clinical research and clinical routine and integrating them into the relevant archive systems. The DIC accompanies projects in this area and supports the implementation of department-specific ideas for the adaptation and further development of the system as part of contract development.
Research databases
In order to provide researchers with a wide range of database solutions, the DIC enables the provision of different databases with different benefits. The DIC staff can help you decide which database is best for you and provide access to the appropriate software solutions provided by the DIC.
Analytical tools
For the evaluation of data sets, the DIC offers analysis tools already established in the research environment as well as in-house developments. The DIC Data & Knowledge Management staff advise researchers on analysis options and support the use of software solutions. The DIC also offers contract development and system customization services.
As part of its digitization projects, the DIC Giessen has developed a system for capturing questionnaires used in clinical research and clinical routine and integrating them into the relevant archive systems. The DIC accompanies projects in this area and supports the implementation of department-specific ideas for the adaptation and further development of the system as part of contract development.
Research databases
In order to provide researchers with a wide range of database solutions, the DIC enables the provision of different databases with different benefits. The DIC staff can help you decide which database is best for you and provide access to the appropriate software solutions provided by the DIC.
Analytical tools
For the evaluation of data sets, the DIC offers analysis tools already established in the research environment as well as in-house developments. The DIC Data & Knowledge Management staff advise researchers on analysis options and support the use of software solutions. The DIC also offers contract development and system customization services.
Other Services
Teaching support
The Institute of Medical Informatics (IMI) offers the service KiVi (Clinical Video Conferencing System) for the realization of digital lectures, which can be used in the context of teaching. In cooperation with the IMI, the DIC advises and supports users in the context of application, system setup and possible applications. The DIC also offers the possibility of obtaining anonymized test data sets for teaching and training purposes.
The Institute of Medical Informatics (IMI) offers the service KiVi (Clinical Video Conferencing System) for the realization of digital lectures, which can be used in the context of teaching. In cooperation with the IMI, the DIC advises and supports users in the context of application, system setup and possible applications. The DIC also offers the possibility of obtaining anonymized test data sets for teaching and training purposes.