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

A.4
A.4 Integrated Data Management
between workstation and integration center), a special client-server implementation will be
developed, where the client part running on the study center workstations is distributed automatically
and can run without a network connection.
All data captured through the EDCF application will generally be transferred immediately to
an integration center. This is implicit if it is implemented as a web application using central
servers at the integration centers. If it is implemented as a special client-server solution, all
data are also transferred immediately when a network connection is available. When it is
not, data are temporarily stored locally and synchronized with the server as soon as possible.
In any case, the EDCF application will be generated automatically from a formal description
of the data collection instruments (the “data dictionary”). The application is modularized
along examination topics and methods; it can be extended through additional modules, and
individual modules can be modified without affecting other areas. Access to the application
is differentiated for modules and user roles, i.e., access to a certain application module is
restricted to users in participating institutions using this module who are acting in a role that
requires use of this module. Insofar as possible, the application will reflect the chronological
course of the examinations.
Immediate data transfer in no way affects the responsibility of the study centers for their
data and the need to conduct quality checks on their data. All study data concerning a specific
study subject are fully available to the study center that recruited that participant. The
integration centers operate servers that allow the study centers to view and export all data
regarding their own participants for local use at any time.
A.4.3.3 data from medical devices
For collecting data from medical devices, automated procedures for electronic data transfer
will be implemented. Generally, all data will be transferred to an integration center for central
storage and archiving; if the data are also needed at a competence unit, the integration
centers will make them available to that competence unit.
In most cases, medical devices will store captured raw data locally first. Where these temporary
storage capabilities are not sufficient to guarantee the safety of the captured data
even during temporary network unavailability, additional software or hardware will be added
for that purpose. This may also be necessary for implementing processes for exporting the
stored data from the device and transferring it to an integration center.
The technical means and procedures for storing, exporting, and transferring the data to the
integration centers will use clinical interface standards (e.g., DICOM, HL7) where possible
and will be developed centrally (coordinated by the integration centers) for all the devices
that are uniformly used at all study centers. Details for the processes and the necessary
software and hardware will be developed after final selection of such devices; in some
cases, this selection depends on the results of the ongoing feasibility studies.
Where extra steps are necessary for obtaining ”usable” data from raw data, these will preferably
be implemented as automated processes running at integration or competence centers.
A.4.3.4 handling of paper forms
In addition to electronic data capture, paper forms will also be used for two different purposes:
Firstly, paper questionnaires will be distributed to study subjects, filled-in at home,
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