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

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A.4 Integrated Data Management
and sent back or brought in by subjects visiting study centers. Secondly, paper versions of
all electronic forms will be available as a back-up for electronic data capture.
Paper forms will be prepared and automatically generated centrally (based on the “data
dictionary”), distributed electronically to the study centers, and printed there with individual
pseudonyms (bar codes, for example) added. (Alternatively, depending on cost evaluation,
forms could be printed centrally, distributed to the study centers by mail, and supplemented
with individual pseudonyms there before shipping them to the subjects). The preferred way
of handling filled-in paper forms is to scan them in the study centers (including data capture)
and transfer the data to the integration centers electronically, while paper archiving is done
at the study centers (if necessary). Should the cost prove too high, alternative solutions will
be considered. Options include (a) manual data capture in the study centers, (b) scanning
of paper forms at the study centers and centralized automatic data capture from the images,
and (c) paper forms being sent to the integration centers for central processing.
A.4.3.5 Processing of study data by competence units
Competence units generally work on standardized study data provided to them by the integration
centers. In order to enhance the standardization of captured data and dataflows, direct
transfer of data from study centers to competence units will be avoided insofar as possible.
All topic-specific study data required for the work of a competence unit are provided
in the form of specific views via central servers in the integration centers. More “complex”
data objects (i.e., images, binary data objects) may also be exported automatically to the
competence centers (i.e., copied to their own infrastructure). Since permanent storage and
archiving is centralized at the integration centers, no data need to be stored permanently at
the competence centers.
The results of any processing, interpretation, and review by competence units are captured
in similar ways as in study centers, i.e., by electronic data capture forms centrally
provided by the integration centers or by direct data transfer from technical devices. Both
competence centers and study centers have full access to these results for their respective
subjects at any time.
A.4.3.6 Integration and storage of study data
Through the use of electronic data capture via servers in the integration centers insofar as
possible, all data collected through electronic forms will immediately (or at least as soon as
possible) be integrated and stored centrally. Data from medical devices will also be transferred
to the integration centers as soon as possible, using device-specific procedures,
which will be automated to the greatest possible extent.
The stored data include a change history that documents the original value of each study
data record and the date, reason, and executing person of every change that has been
made afterwards. A version management system keeps all versions of data models and
software and denotes used versions with the stored data to ensure that any specific set-up
and respective data can be completely reproduced at a later point in time.
Data that are no longer actively needed are archived in ways that guarantee their long-term
availability. All data are backed up at regular intervals, and a procedure is in place for restoring
data, if needed, with adequate effort in adequate time. This also includes a procedure
for point-in-time recovery of data, which is able to restore study data in the state they were
in immediately before a failure event.
A.4