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Research

Implementation of a quality management system

The aim of quality management is to ensure that laws, regulations and standards governing the conduct of clinical activities are fulfilled. The implementation of a QM system is principally intended to improve the quality and efficiency of clinical activities.
The basis for a QM system for e.g. clinical trials are standard operating procedures (SOPs).
The objective of the project Group Clinical Activities is to develop QM SOPs and support their implementation. The project Group Clinical Activities supervises the local SOPs, working procedures/instructions and technical procedures, and conducts internal training events. 13 SOPs have now been developed, of which 9 were in force in June 2008.