Quality Management
Our goal is to prepare our study data in the best possible and comparable way for all types of analyses through standardization and quality control.
The pillars of quality management (QM) are:
Standardized Data Collection
To ensure comparable and uniform data collection, SOPs (Standard Operating Procedures) have been created that clearly define the procedures for individual investigations and data collection. In this way as well as through regular employee training, we aim to ensure that all data obtained are as complete as possible and comparable with each other.
Standardized Biobanking
Standardized sample collection, processing and storage is a requirement for performing biomaterial measurements at a high level. SOPs have been created for all processing steps; in addition, pipetting robots prepare samples and with the aid of standardized sample management (sorting by quality, mirrored storage) the samples are then stored in temperature-monitored freezers (biobanking).
Quality Control of Data
The data management staff ensure the provision and updating of the survey forms (eCRFs = electronic Case Report Form), check the raw data for completeness and plausibility and maintain the databases. In the QM databases, the quality-controlled data is stored in the firewall-secured, departmental server landscape. The QM databases are used by statisticians as a data source for scientific publications.
Transparency and Documentation
For the clear presentation of all variables (measured values, questions from questionnaires/interviews/eCRFs), variable manuals are used in all studies and at all survey times, which are available to scientists for planning of evaluations and research projects, among other things. Adjustments made to the data as part of quality control are documented using error reports so that all changes can be traced at any time.
