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

A.5 Methods for quality assurance and quality control
An essential component of quality assurance and quality control is training, retraining, and
certification of study staff. A training description with information on contents of the training
course, definition of the number of test runs, and runs conducted under supervision will be
described in the SOPs, which will also include training materials. Face-to-face training will
be held centrally (or regionally, with special attention on having the same training in all regions)
and is supplemented with local training sessions held by instructors selected by the
competence units. Newly hired staff will receive the same training procedures as the core
personnel. Annual retraining and recertification are necessary to avoid drift over time. Study
staff will be certified upon completion of the training course; the certification procedure will
directly follow the training sessions. Certification criteria will be defined by the competence
units and approved by the working group on quality management. The certification results
will be documented for future reference. Training will be coordinated by the central quality
office; organizational issues will partly be delegated to regional or local units.
Before training and certification start, the respective procedures will be piloted using mock
study subjects and, if approved, with actual study participants.
Site visits represent an important part of the quality monitoring process. All centers will be
visited by external quality management personnel once per year. The aim of these site visits
is to assess whether study procedures are performed according to the SOPs (interviews,
medical examinations, calibration, and use of devices). Information on how procedures are
performed at the study centers will be collected using quality protocols and checklists which
are derived from the SOPs. The protocols of the site visits comprise part of the quality reports.
Monitoring procedures will be aimed at (1) checking the quality and completeness of
the data on a regular basis, (2) identifying intra- and inter-(examiner, study nurse, interviewer,
technician, instrument, and study center) variability, (3) identifying temporal changes in
study parameters or examinations over time, and (4) identifying data outliers.
Monitoring procedures at the level of the study center: Specific checklists and quality
protocols will document the quality assessment at each study center. The preferred means
of applying checklists and quality protocols is in electronic form, integrated with the centralized
EDCF application; paper may be used where this is not feasible. Checklists will be
used to ensure that each study subject participates in all medical examinations and interviews.
Additionally, particulars that arise during the assessment visit are documented (e.g.,
reason why a study subject did not receive a certain examination). Quality protocols include
data analyses and data presentations regarding specific quality aspects of the study. For
this purpose, gold standards or alloyed gold standards will be identified by the competence
units to monitor the accuracy of the examiners or instruments and to analyze intra- and
intervariability in study center staff, assessment instruments, and study centers. For each
theme-specific assessment module, specific quality control requirements will be assessed
and adequate standards will be identified by the competence units to verify the accuracy of
the examiners or instruments and to analyze intra- and intervariability in study center staff,
assessment instruments, and study centers.
Missing, incorrect, interchanged, or nonclassifiable values will be documented and interpreted
by the local quality manager and discarded if necessary. Conspicuous values will
be discussed with experts and documented for future reference. The plausibility of data
outliers will be monitored regularly both by the local quality manager and by the respective
competence units. Calibration and technical maintenance of the technical equipment will be
documented, and the records will be analyzed by the competence units responsible for the
respective kind of equipment. In order to assess intra- and intervariability, each assessment
item will be tested against a predefined “gold standard.” The variation will be assessed,
documented, and interpreted as part of the quality protocol, which will subsequently be
circulated to study staff and will result in corrections, instruction updates, and retraining
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A.5