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

A.4
A.4 Integrated Data Management
cost of setting up and maintaining a greater number of specialized units each with their own
infrastructure. Currently planned competence centers are:
� Imaging: Handling of all MRI, DXA, ultrasound, and echocardiography data. This includes
providing teleradiology services to different places where experts on specific
parts of the images are located; running separate competence centers for this would
not be cost efficient.
� Physical activity and ECG: Both of these instruments require application of algorithms
on the collected data to derive characteristic values. For this reason, they could be
handled together in one competence center with a common infrastructure and supported
by the same IT personnel. While the algorithms are relatively well-established
for ECG, methods for deriving measures of physical activity from accelerometry data
are in a more experimental state and will probably be improved continuously and reapplied
multiple times while the study is running.
� Secondary data: The selection of external sources and data elements, the collection
of data from those sources into temporary storage, and the mapping of such data
into the common data model of the study database requires not only a considerable
amount of manual work but also specialized hardware and software. Possible procedures
for the use of health insurance data and social insurance data are described in
Sect. A.7.2.3 of this document.
� Biobanking: A biobank is similar to a competence center as it uses special infrastructure
and processing, even though not (only) for data but for biosamples.
In addition to these proposed competence centers, a number of competence panels will be
set up for the quality management of data collection instruments not covered by competence
centers and also in the field of disease-specific follow-up.
A.4.2.4 Trust center
The trust center generally takes on all tasks in which personal data of the study subjects
need to be handled at the national level:
� Generation of unique pseudonyms for (potential) study subjects: Although it is possible
to generate pseudonyms at the study centers and make them unique, for example,
by adding a study center ID, central generation of pseudonyms is considered as the
preferred alternative because it offers the additional possibility to recognize and avoid
repeated entry of a single person via different study centers with different pseudonyms
(so-called synonyms); such synonyms become more likely when sampling is
done in multiple tranches. For the best effect, potential participants will be checked for
double entry immediately after sampling and before contacting them.
� Central back-up storage of study participant data: Personal identifying data for the
study subjects are kept at the trust center as a back-up for cases of data loss in the
study centers. Especially in later phases of the study, these data may be useful for
reidentifying participants (e.g., in case of incidental findings).
� Data linkage with external sources at the national level: External sources of secondary
data that operate at a national level must also be queried centrally (rather than by
each of the study centers individually). Such queries must contain personal identifying
information about the study subjects, which must not be stored centrally together with
medical study data. Therefore, queries for data from external sources are prepared
by the competence center for secondary data and supplemented afterwards with personal
identifying information about the respective subjects by the trust center (which,
however, never sees the replies to those queries). See Sect. A.7.2.3 for details.
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