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

A.5
A.5 Methods for quality assurance and quality control
For certain assessments, replicate measurements will be carried out in order to identify data
errors. All measured values will be recorded, so that implausible values can be discarded
afterwards and more accurate data obtained.
A.5.5.2 quality control of medical examinations
Checklists will document potential problems that arise during the medical examinations
and will provide pertinent information to the competence units. Assessment devices will be
calibrated and inspected regularly using the same algorithms at each study center to ensure
reliable and comparable data collection. The procedures will be developed by competence
units, compiled and distributed by the central quality office, and carried out by study center
personnel under supervision of the local quality manager.
A.5.6 quality assurance and quality control of the collection and processing
of biological specimens
Aspects that potentially impact upon the quality of biological specimens include the technical
skill of study examiners and laboratory technicians, the accuracy in collecting and
processing biological specimens, accuracy in liquid handling, transport, and storage conditions,
and the time elapsed between sample collection and sample storage.
A.5.6.1 quality assurance of biological specimens
To ensure comparability between the study centers and minimize variability regarding preanalytic
artifacts, all study centers will apply the same liquid handling procedures. The use
of a high-throughput liquid handling platform in each study center will ensure precision and
accuracy in the workflow.
Detailed SOPs and specific training materials for sample drawing, collection, processing,
transportation, and storage will be compiled by the competence unit on biomaterials. Different
techniques for sample drawing, collection, processing, transportation, and storage will
be tested in feasibility and pilot studies designed to address adequate testing of all procedures
and techniques and to identify and solve potential problems in the workflow.
Criteria and intervals for accuracy checks will also be defined by the competence unit on
biomaterials. All results of accuracy tests will be documented in a data quality protocol.
The collection of blood, urine, and saliva will be performed by study nurses, who will participate
in a specific training and certification course on the standardized collection of biological
specimens. Laboratory technicians responsible for sample processing and storage
will also be trained according to specific SOPs. Examiners and technicians will be certified
upon completion of the training course. A video presentation on the collection and handling
of biological specimens is currently being considered as an additional training option. The
training will be coordinated by the central quality office, based on recommendations from
the competence unit on biomaterials. Regional structures will be used for practical organizational
issues where possible.
Varying time intervals between sample drawing and processing will be tested in a feasibility
study to analyze the impact of elapsed time on the quality and viability of the various biomaterials.
Criteria related to sample transport (e.g., transport on dry ice or in ice water) will
include details regarding the time of transportation, the sample temperature, and temperature
deviations during transportation.
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