Quality assurance

Quality assurance, also called quality assurance, includes all systematic measures that ensure that the clinical trial is conducted in accordance with Good Clinical Practice (GCP) and the applicable guidelines and laws (AMP, MPG). The aim of quality assurance is to avoid systematic errors and bias through professional observation or study plans, to optimize the validity and completeness of the data and to minimize possible risks and errors for insufficient / poor study quality.

For quality assurance, numerous demands are made in various areas:

With regard to structural quality, requirements are made of all persons participating in the study(investigators, study nurses, sponsors).

The process quality includes the procedures during the study (planning, database creation, monitoring, statistical evaluation, reporting, archiving and publication).

Result quality includes measures for quality assurance of the data and statistical analyses(biometrics).

As quality assurance measures, the Clinical Research Organisations or the sponsors in particular draw up SOPs (Standard Operating Procedures). These include work instructions for all areas of the clinical study. Furthermore, internal and external audits are carried out to ensure that the study plan is implemented.

The VFA (German Association of Research-based Pharmaceutical Companies) recommends quality assurance measures that ensure validity and representativeness. Furthermore, internal processes should be described by process descriptions such as SOPs.

Quality assurance processes should implement the recommendations of the BfArM and the Paul-Ehrlich-Institut (PEI) and always comply with guidelines and laws.