General
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:

• Logistics
• Clinical execution
• Site-Investigator support
• Data collection

The Project Team within the CRB consists of project managers, data managers, monitors and a clinical trial assistant. 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 1st 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 1st monitor was employed, not being dependent of third parties, data can be monitored and collected more easily.

Progress

1990	1 employee, 5 liver studies
	Only admininistrative support
2004	4 employees, 12 liver studies
	Coordination of international multicenter studies
	Development of 1 European multicenter study
2001	First research nurse start
2006	9 employees, 20 liver and gastroenterology studies
	Coordination of 2 large international multicenter studies
	Data monitoring of 1 multicenter study (biopsy handling)
	Development of 2 singlecenter and 2 multicenter studies
2008	11 employees, 47 liver and gastroenterology studies
	Coordination and development of 2 international multicenter studies
	Coordination of multicenter study
	Coordination of 1 singlecenter study
	Data monitoring of 1 multicenter study (biopsy handling)
	Development of 1 singlecenter study
2009	13 employees, 50 liver and gastroenterology studies
	Coordination of 2 international multicenter studies
	Data monitoring of 1 multicenter study (biopsy handling)
	Coordination of 2 single-center and 2 multicenter studies
2010	10 employees, 30 liver and gastroenterology studies
	Coordination of 2 international multicenter studies
	Data monitoring of 2 multicenter study (biopsy handling)
	Coordination of 1 single-center and 5 multicenter studies
2011	11 employees, 37 liver and gastroenterology studies
	Coordination of 3 international multicenter studies
	Coordination of 2 singlecenter studies and 4 national muticenter studies

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Organogram-2010.pdf