Scientific Concept of the National Cohort (status ... - Nationale Kohorte

A.4.2 Organizational model
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A.4 Integrated Data Management
Based on the requirements described above, an organizational model for data management
has been developed, which also forms the basis for defining processes and dataflow.
It involves three types of main organizational units:
� Study centers: recruitment, study subject management, and data collection
At the study centers, study subjects are recruited and managed, examined, and interviewed.
In the process, study data and biosamples are obtained. Secondary data
from local sources (physicians, local registries) are collected by the study centers as
well. Quality management tasks involving local records are executed by study centers
personnel.
� Integration centers: integration and processing at the national level
Two integration centers collect and integrate all study data from the study centers
and competence units. They execute automatic checks for consistency and completeness
and generally carry out all the technical procedures for quality assurance
and quality control that are not covered by a specialized competence unit. They
provide access to standardized study data to all the study centers and offer a technical
platform for data analysis by internal and external scientists. The two integration
centers offer identical services and both store all data, so they can take over each
other’s tasks if needed, thus guaranteeing redundancy of all main processes and
high service availability.
� Competence units: topic-specific integration, processing, quality assurance,
and standardization
Competence units for particular, thematically defined areas carry out centralized tasks
of enriching, standardizing, assuring quality, and controlling quality of data. These
tasks include:
– Processing and interpreting “complex” kinds of data (such as MRI or ECG data)
– Standardizing, assuring quality, and performing comparative quality control over
all study centers
– Collecting data at the national level, e.g., secondary data from health insurances
– Performing central tasks in endpoint-specific follow-up
Competence units operate either as competence centers or as competence panels, depending
on the technical needs of the area being covered; see Sect. A.4.2.3 for details.
figure 4.1 gives an overview of the resulting organizational structure, and figure 4.2 visualizes
the relationships between the different types of organizational units by showing the
most important data flows between them.
Apart from the data management tasks assigned above, two more functions will be implemented
at the central level:
� A trust center is needed for tasks where personal data are to be processed or study
subjects need to be reidentified at the central level.
� The administrative tasks related to clearing and transfer of data from the national cohort
for analysis through internal and external scientists will be taken on by a central
transfer and documentation unit.
A.4