Quality management and assurance
Quality management and assurance is an integral component of our studies and is practiced using a standard work process at the Klinische Forschung Gruppe Nord.
- regular training on formalities, study contents and procedures
- weekly discussions within the teams executing a study together, as well as within the entire team
- SOP: All important processes and responsibilities regulate standard operation procedures
- structured training phases for all new employees
- work instructions and job descriptions supplement the SOPs
- all studies will be prepared, necessary documents will be provided and presented according to SOP, to employees.
- the original data collection is developed in the form of standardised documents
- all patient medical records are submitted to the patients doctor to keep their files up-to-date
- all studies are examined at random by the quality assurance commissioned study nurse – a position which exists at each location.
- all monitoring notes and follow-up letters are processed by the quality assurance commissioners; all necessary measures are implemented immediately as soon as they are indicated.