This page contains websites and documents that will give you more information about the quality assurance of the CRU.

Information for the starting researcher (for VUmc-employees only)

Requirements for site facilities according to GCP

Requirements according to GCP.

Storage of documentation

All study specific documents have to be kept in a locked cabinet in a locked room, which is available in the CRU office. It is also possible to use the locked cabinet in room ZH 4A72  (please contact the manager of the CRU).

Storage of body material

Freezers for storage of body material are in the centrifuge room. In addition, the CRU uses these facilities for biobanks VUmc.

Website Biobanken > 
https://www.vumc.nl/afdelingen/klinische-chemie/htw-proj-Biobank-Onderz/

Kwaliteitsnet > 
http://kwaliteitsnet/iprova/iportal/Default.aspx

Office for research assistants and monitors

Study coordinators and research assistants have their own Central office, located at ZH 4A72. When it is necessary to schedule a monitoring visit for an external study, a suitable place has to be found. This may be one of the test room and when it is not available, an office room. If necessary, please contact the secretary of internal medicine.

Research rooms

The CRU has 7 test rooms, exclusively intended for conducting clinical scientific research. Researchers can make an appointment by contacting the research assistants or directly with the physician researchers.

Waiting room

The waiting room of the CRU is in corridor ZH4A.

Research laboratory

The CRU does not have its own research laboratory. For all laboratory tests provisions we utilize the  KCL VUmc. If necessary, we will make use of certified external laboratories for multi centre studies.

Medical devices

The CRU has a service contract renewal (DVO) with the FMT of VUmc. This contract allows for clear agreements on medical equipment used at the CRU. The degree of maintainance of medical equipment, the so-called maintenance regime, depends on the researcher's demands. As a researcher you need to estimate the risk for the use of the medical devices and you need to describe it in your research protocol.

Electronic data capturing

For every scientific research it is recommended to use the Central clinical trial management system, Open Clinica in the VUmc.

Support Open Clinica > https://intranet.vumc.nl/afdelingen/thema/crb/6784830/6784837/

Archive space

All studies have to be archived after the promotion date. The CRU archives the studies in the CMA (Central Medical Archive).