Samenvatting

The complexity of regulations governing investigator-initiated
trials (IITs) places a great burden on hospitals. Consequently,
many hospitals seek to alleviate regulatory pressures by seeking
an alternative quality management system (QMS). This
paper takes the Netherlands as a case. To investigate how
QMSs for IITs are organized in Dutch hospitals, we adopted
the theoretical concepts of mentoring and monitoring in
a mixed methods study in the period 2014–2018. In clinical
practice and international guidelines, monitoring is seen as the
standard quality assurance for ongoing trials. However, hospitals
have implemented monitoring programs that resemble
mentoring. The contrast between these ideal types is less
pronounced in practice as both combine elements of compliance
and feedback for learning in practice. In a monitoring
setting, learning is one-way, from monitor to researcher;
whereas mentoring focuses on mutual support and learning.
To tackle problems in each system, the authority of the Board
of Directors (BoD) and the BoD’s relationship with staff members
are crucial. We discuss the challenges that BoD and staff
face in keeping an integrated view of the various components
of QMSs.