Clinical research

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 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 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

   
 2012  8 employees, 47 liver and gastroenterology studies
   Coordination of 3 international multicenter studies
   Coordination of 5 national multicenter studies
   
 2014  7 employees, 57 liver and gastroenterology studies
   Coordination of 3 international multicenter studies
   Coordination of 4 national multicenter studies
   
2015 6 employees, 48 liver and gastroenterology studies
  Coordination of 2 international multicenter studies
  Coordination of 3 national multicenter studies