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

A.5
A.5 Methods for quality assurance and quality control
All diagnoses will be coded according to the ICD version being effective at the start of the
study. Revisions and/or diagnostic progress will be considered as add-on diagnoses, if
deemed appropriate. Information that leads to a specific ICD code will be stored electronically
such that later revisions can be used with only minimal additional effort.
The feedback from the expert assessments to the study centers will enhance the diagnostic
quality and comparability of the diagnoses across centers and over time.
The results of the abovementioned benchmarking process, quality indicators comparing
study center-based diagnoses with the results from the experts’ assessments, and the number
of events stratified by study center will be disseminated on an annual basis.
A.5.9 quality assurance and quality control of data management
High standards for data acquisition, data processing, and data storage will be enforced by
implementing quality assurance and quality control procedures in data management.
A.5.9.1 quality assurance of data management
Quality assurance during the system analysis phase
A system specification document will specify the following points:
� Overall project aims:
– “Must” criteria: performance parameters that the future data management system
will comply with (see Sect. A.4.2);
– “Can” criteria: it is not absolutely necessary to fulfill these criteria, but will be
strived for if sufficient resources are available.
– “Borderline” criteria: parameters and functions beyond the reach of the anticipated
software system (e.g., quality control of the data at the level of the competence
unit for data management can be individually performed with other statistical
programs and therefore is not part of this solution).
� Product application:
– Application domain: the system to be created will be used only for the National
Cohort. It is possible that a similar system could be used for other future studies,
but this is beyond the scope of the current project.
– Target groups: the main target group for this system consists of study personnel
from individual study centers.
– Working conditions: the system will run as a web application on servers in the
integration centers, with permanent surveillance of IT systems, data items, and
data flow by central data administrators.
� Product functions: exact and detailed descriptions of each function (see Sect. A.4.2)
� Product data: the data that need to be stored over a longer period of time, seen from
a user’s point of view.
� Product performance: specifications concerning processing time and data accuracy,
simultaneous updates on all servers.
� User interface: the software will be designed for both keyboard and touch screen use.
In addition, a concept for a role-based access model will be defined.
� Nonfunctional requirements: external rules and laws that will be respected by the software,
security requirements, and platform dependencies. The system will work with
pseudoanonymous data. Access to personalized data will be restricted to a limited
number of persons; the components that manage personalized data will be specially
protected.
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