Prospective cluster-randomized evaluation of strategies for on-site monitoring adapted on a study-specific basis in
conjunction with additional quality assurance measures.
is a project to evaluate risk-adapted monitoring strategies for clinical
trials. The adapted monitoring strategies investigated have been developed with
a methodology that was initially developed heuristically in preliminary
projects, integrating numerous experts. It allows risk classification of
non-commercial clinical trials and assigns each of those risk classes an
adapted monitoring strategy.
efficiency of this method is now evaluated in a prospective cluster-randomized
investigation. The focus is on the question:
Is a focused, reduced monitoring strategy that is adapted to the design
and objectives of the clinical trial and implemented by monitors specifically
trained for the study sufficient to ensure achievement of the objectives of
good clinical practice and does it help to obtain meaningful results?
For this purpose, ADAMON cooperates with numerous clinical studies in which for each participating trial site a randomized decision is taken as to whether the site will be monitored on site using a specifically adapted monitoring strategy or an intensive monitoring strategy ("full monitoring“). A final audit is planned for each trial site. The audit results are crucial for a comparison of the two monitoring strategies.
funding period is December 2008 to 30 June 2016. The project is being funded by
the German Federal Ministry of Education and Research (BMBF). The project
application was developed within the scope of preliminary TMF projects,
integrating the TMF working group "Management of Clinical Studies".
ZKS Leipzig (project leader: Dr. Oana Brosteanu) is in charge of filing the
application and implementation. The project team consists of representatives of
the network of Coordination Centres for Clinical Studies (KKS Network) and
Competence Networks in Medicine (KN) and cooperates with employees of the
German Federal Institute for Drugs and Medical Devices (BfArM).