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

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A.4 A.4 Integrated Data Management All study data will be mirrored between the integration center sites in order to achieve a high degree of availability. Together with all services also being provided in identical ways, each integration center can stand in for the other in case of any failure. Because of the complexity of these tasks and the effort required to fulfill them with the necessary degree of reliability, the option of a centralized service being provided by the integration centers saves considerable effort in comparison to any other solution that relies on local data storage at the study centers. A.4.3.7 Analysis and use The integration centers implement the technical part of making study data available for scientific analysis, while the administrative part is managed by the transfer unit. Analyses can either be executed on a computation platform provided by the integration centers (by granting access to project-specific views of subsets of study data, such that study data never leave the platform if not necessary), or specific subsets can be prepared, additionally coded with new pseudonyms, exported, and transferred physically to the project partner analyzing the data. Background literature to the topics covered in this chapter is in references 751-780. 154
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
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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 s
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A.1 A.1 Introduction and overview
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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 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 genetics of BM
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A.3 A.3 Study design Project title
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A.7 A.7 Ethical aspects ing finding
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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 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 727. Ryu, O.H., et a
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C.3 References 757. BSI-Standard 10
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C.3 References 822. Hegenscheid, K.
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