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

Contents
A.3.8.2 Social security data ......................................................................133
A.3.8.3 Environmental data .......................................................................135
A.3.8.4 Strengths and possible limitations of secondary data use
for the National Cohort .................................................................135
A.3.8.5 Experiences with data linkage of secondary data
in epidemiologic studies in Germany ............................................137
A.3.8.6 Data quality and quality assurance of secondary data ..................137
A.3.9 The National Cohort in the context of other cohorts of adults
in Germany and internationally ................................................................ 137
A.4 INTEGrATEd dATA mANAGEmENT ...........................................................143
A.4.1 Aims and requirements ............................................................................ 143
A.4.2 Organizational model .............................................................................145
A.4.2.1 Study centers ................................................................................147
A.4.2.2 Integration centers ........................................................................148
A.4.2.3 Competence units .........................................................................149
A.4.2.4 Trust center ...................................................................................150
A.4.2.5 Data transfer and project documentation unit ..............................151
A.4.3 Technical aspects of data collection, processing, storage, and
analysis ........................................................................................................151
A.4.3.1 Software infrastructure ..................................................................151
A.4.3.2 Electronic data capture .................................................................151
A.4.3.3 Data from medical devices ............................................................152
A.4.3.4 Handling of paper forms ................................................................152
A.4.3.5 Processing of study data by competence units .............................153
A.4.3.6 Integration and storage of study data ............................................153
A.4.3.7 Analysis and use ...........................................................................154
A.5 mEThOdS fOr quAlITy ASSurANCE ANd quAlITy CONTrOl .....155
A.5.1 Organizational structure for quality assurance and quality control . 155
A.5.1.1 Internal quality management ........................................................155
A.5.1.2 External quality management ......................................................156
A.5.2 Principles for quality assurance and quality control
in the National Cohort ............................................................................. 156
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