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

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A.4 A.4 Integrated Data Management figure 4.1: Organizational structure for data management of the National Cohort Competence units Competence center A Competence center B Competence panel C . . . . . . SC 1 SC 2 ... Fig. 4.2 a SC 1 146 SC n Integration center 1 Transfer unit Integration center 2 SC 2 figure 4.2: Data flow among main organizational units Collected study data Study Centers Integration Centers ... SC n Study centers Standardized study data Trust center Quality information Competence Units Derived study data Central functionalities Trust Center
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
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The National Cohort A prospective e
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Applicants Applicants Applicants Cl
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Applicants IV
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Executive Summary 2. The National C
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Executive Summary 3. Scientific aim
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Executive Summary essary to address
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Executive Summary 7. Examples for s
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Contents A.2.4 major areas of expos
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Contents A.3.8.2 Social security da
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Contents A.6.4.2 Minimally detectab
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Abbreviations C.2 mEThOdS fOr STATI
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Abbreviations DXA Dual-energy x-ray
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Abbreviations CHS Cardiovascular He
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A.1 A.1 Introduction and overview a
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A.1 A.1 Introduction and overview s
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A.1 A.1 Introduction and overview T
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A.1 A.1 Introduction and overview m
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A.1 A.1 Introduction and overview
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A.1 A.1 Introduction and overview s
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A.1 A.1 Introduction and overview
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A.1 A.1 Introduction and overview P
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A.1 A.1 Introduction and overview t
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A.1 A.1 Introduction and overview A
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A.2 A.2. Scientific background and
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A.3 A.3 Study design ment instrumen
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A.3 A.3 Study design Table 3.2: Des
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A.3 A.3 Study design Table 3.3: Dis
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A.3 A.3 Study design the participan
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A.3 A.3 Study design with a prepare
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A.3 A.3 Study design rural areas, t
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A.3 A.3 Study design A.3.2 Baseline
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A.3 A.3 Study design Modules 70 Int
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A.3 A.3 Study design ovarian carcin
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A.3 A.3 Study design Table 3.5: Spe
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A.3 A.3 Study design depression and
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A.3 A.3 Study design to the extent
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A.3 A.3 Study design ers to vaccina
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A.3 A.3 Study design certain foods)
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A.3 A.3 Study design A short instru
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A.3 A.3 Study design ticipants and
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A.3 A.3 Study design a resting time
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A.3 A.3 Study design index, convent
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A.3 A.3 Study design Although the i
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A.3 A.3 Study design air and then t
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A.7 A.7 Ethical aspects pants, trav
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A.7 A.7 Ethical aspects Data handli
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A.7 Table 7.2 Availability of ident
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A.7 A.7 Ethical aspects Should bios
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A.7 A.7 Ethical aspects ing finding
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A.7 A.7 Ethical aspects 206
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C.1 C.1 Annex: Description of the s
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C.1 C.1 Table Annex: 1: Cluster Des
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C.2 C.2 Annex: Methods for Statisti
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C.2 Table S6.5: Sample size needed
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C.3 References 17. Keil, U., et al.
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C.3 References 50. Benjamin, E.J.,
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C.3 References 85. Calle, E.E. and
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C.3 References 121. Walter, R., D.J
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C.3 References 155. Ross, R., Ather
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C.3 References 189. Ghiotto, F., et
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C.3 References 225. Schmidt, C.O.,
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C.3 References 260. Eussen, S., et
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C.3 References 294. McCrae, R.R. an
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C.3 References 327. Lynch, J.W., G.
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C.3 References 360. Mair, C., A.V.
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C.3 References 395. Lesourd, B., Nu
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C.3 References 431. Statistisches B
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C.3 References 462. Bundeszentrale
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C.3 References 494. Rammstedt, B. a
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C.3 References 526. Mack, F., et al
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C.3 References 560. Palatini, P., A
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C.3 References 590. Greenland, P.,
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C.3 References 623. Olin, A.C., et
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C.3 References 658. Pate, R.R., J.R
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C.3 References 691. Zenge, M.O., et
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C.3 References 727. Ryu, O.H., et a
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C.3 References 757. BSI-Standard 10
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C.3 References 790. Davis, C.E., et
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C.3 References 822. Hegenscheid, K.
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