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

figure 4.3: Organizational units and their functions
Study centers
(n = 18)
Integration
centers
(n = 2)
Competence
centers
(3 � n � 5)
Trust center
(n = 1)
Transfer unit
(n = 1)
A.4.2.1 Study centers
Fig. 4.3
Subject management
> Recruitment
> Scheduling
> De-Identification (coding)
> Central storage of all study data
> Data quality checks
> Providing data to study/competence centers
> Analysis support
147
A.4 Integrated Data Management
Data collection
> Interview/Examination
> Sample collection
> Quality assurance & control
> Processing and interpretation of topic-specific study data
> Topic-specific quality assurance & comparative quality control
> Centralized data collection (esp. secondary data)
> Central tasks in topic-specific follow-up
> Centralized back-up of personal identifying data
> Pseudonym generation (optionally; for coding)
> Central tasks involving re-identification
Administrative tasks related to data analysis
The tasks of study centers are divided into two main areas: study subject management and
data collection. This division is also reflected in figure 4.4, which schematically depicts the
basic structure of a study center from a technical point of view: The study subject management
part (including recruitment, schedule management, registration, and (re-)contacting)
is shown on the left-hand side, the data collection part in the middle. In the two parts, separate
kinds of data are processed: Personal identifying information for the study subjects is
handled in the subject management part and stored by the unique identification number
ID-P (see Sect. A.7). In the data collection part, all collected study data regarding a particular
subject are identified by the pseudonym ID-S. The two parts are linked by the relation
between ID-P and ID-S, which is created during recruitment, and is handled with special
care concerning confidentially.
Study centers are built as similarly to each other as possible, including uniform hardware,
software, and data models that will be developed centrally.
Personal identifying information for the study subjects is stored in a local database at each
study center, separately from any medical study data. Access to this database is restricted
to a few authorized persons within the study center. The information is also sent to the overall
subject list (“master patient index”) at the trust center for a central check for double entries,
pseudonym generation (for coding), and as back-up for data safety reasons. However,
A.4