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

A.5 Methods for quality assurance and quality control
A.5 Methods for quality assurance and quality control
A.5.1 Organizational structure for quality assurance and quality control
To ensure that the study conduct as a whole, including data collection and data handling,
is of high quality over time and across study centers, a quality management system will be
established, as described in Part B. During the set-up phase of the study, we will decide
whether this system will be certified according to ISO 9001, as, for example, in the Heinz-
Nixdorf-Recall-Study.
This section concentrates on standardized procedures for quality assurance and quality
control, which have been developed and are being established irrespective of the presently
open certification issue. The following figure depicts the organizational structure of quality
assurance and quality control in the National Cohort (figure 5.1).
figure 5.1: Organization and communication of external and internal quality management
Recruitment
centers
C1, C2, C3...Cn
External quality management
Central quality office
Integration
center 1
Internal quality management
155
Integration
center 2
Competence
units
e.g. imaging,
ECG, ...
As shown in the figure above, we distinguish between internal quality management and
external quality management.
A.5.1.1 Internal quality management
The organization of internal quality management is congruent with the general organizational
model introduced in Sect. A.4 and supplements it with an additional organizational unit,
the central quality office. The roles of the organizational units in respect to quality management
are detailed in the following.
Study centers: The study centers will implement quality standards at the local level according
to study-wide SOPs. Study centers will continuously document their study procedures
in quality protocols. These documents will include feedback from study personnel along
with suggestions for improvements. A local quality manager will be responsible for all quality
management-related processes inside each study center. He/she reports directly to the
head of the study center and represents the center in the working group for quality management
at the central level.
Competence units: For each theme-specific data assessment module (e.g., data from
ECG, MRI), competence units are responsible for issues related to quality assurance and
quality control. Each competence unit is organizationally and scientifically responsible for
that particular theme. The competence units will formulate quality requirements, ensure that
quality requirements are fulfilled, take measures when quality issues arise, and communi-
A.5