Personnel

Clinical research is teamwork.

For every study a research team is defined  and thus dedicated to this particular project. This group consists ,  of  dedicated physicians and  paramedical staff.  (see attached organigram).

In practice the medical team typically consists of a number of physicians called ‘subinvestigators’ (SI), being lead by and under supervision of the main investigator, called ‘principal investigator’ (PI). 

As for the medical team, for each study,  a paramedical team is defined aswell..  This team is under supervision of the nurse in charge of this particular study (study coordinator).  Specifically for CTO this study coordinator will coordinate the participation of  every patient throughout the entire study protocol.  This nurse has a specific background in clinical study management  and excecution.  He/she performs administrative and nursing procedures as well as management and processing of the  data gathered during this trial.  He/she is also co-responsible for patient counselling and support through the course of the study. 

Each team member has the necessary qualifications (education, training and experience) in accordance to ‘Good Clinical Practice (GCP).  

Specialists in haematology, medical oncology, radiotherapy working for the Oncology Centre can act as  principle investigator.  Eight study nurses and one administrative assistant are working for the CTO unit under supervision of the coördinator department Cancer Research, who is in charge of the full coordination of ongoing studies at CTO.

Since 2010  a dedicated  physician – quality control manager assures on a permanent basis the certification of the unit according to ISO 9001:2008.

An intensive cooperation with pharmacists, laboratories and other medico-technical  departments within the hospital is established according to written and agreed-upon procedures.