Since 1990 the Clinical Research Bureau (CRB) facilitates trials commissioned by the SLO. CRB's mission is to conduct and monitor administrative procedures, maintaining (inter) national networks and supporting clinical research performed within the Department of Gastroenterology and Hepatology. There is a large amount of experience in designing and conducting research projects that meet (inter)national laws and guidelines essential to the performance of these trials.
The CRB has a Clinical Research Team, a Project Team and a Statistician. The Clinical Research Team consists of a study coordinators, research nurses and a research assistant. Due to years of experience in conducting (inter)national trials in the clinic setting, their knowledge is invaluable. There are research rooms in the outpatient clinic of the Department Gastroenterology and Hepatology where all Protocol required transactions are performed during any visit. This results in optimum data collection and contentment among participating patients.
Their main tasks are:
- Clinical execution
- Site-Investigator support
- Data collection
The Project Team within the CRB consists of project managers and a data manager. This team is an expert in setting up (inter)national investigator initiated trials taking into account all laws and guidelines applicable. Due to their network they can act as intermediary between other centres, pharmacist, laboratories, etc. Their main tasks are:
Support protocol development
- Project plan, finances and agreement(s), study logistics
- Total project management
- Data management
Submissions Ethical Committee and Institutional Review Board
- In addition the CRB can also support statistical analysis.
The implementation of standard operation procedures (SOP's), workinstructions and personal portfolio's contributes our endeavour for ever increasing quality.
Overview of activities
The research bureau started in 1990 with 1 employee and gave mainly administrative support for 5 liver studies. In 2001 the first research nurse was employed. This meant that the research at a clinical setting could be realised and contract research could be conducted. In 2008 the first monitor was employed, not being dependent of third parties, data can be monitored and collected more easily.