Clinical trial monitoring is broadly based on
protecting the rights and the well-being of the human research subjects,
overseeing the progress of the trial, and ensuring that the trial is conducted
in compliance with the applicable regulations, SOPs and study documents . The
systematic application of the recently introduced Risk Based Monitoring (RBM)
technique is facilitating a collaborative vigilance approach, and a new
definition of clinical trial monitor is evolving. A clinical trial monitor no
longer seems to be a single entity but a group of people from cross functional
teams that share joint accountability for overall data monitoring and quality
To explore the
evolving role of a clinical trial monitor and other key study team members in
the Risk Based Monitoring landscape.
A literature search was conducted, followed
by several discussions and brain storming sessions with key functional study
team members currently working in the RBM pilot trials. Some limitations with
this methodology were a lack of available literature specific to the topic
under study, as well as the lack of sufficient industry experience in the
implementation of the RBM practices at present.
monitoring was based mostly on data review in silos by the monitors. RBM and
the associated technologies have created an opportunity to assess the study and
center specific risks at each level of the data hierarchy by the appropriately
qualified study team members for a continuous governance of clinical study
data. The roles and responsibilities of these core study team members are
continuously shifting and it is likely that this shift, along with training and
continuous adaptation, will re-define the face of a clinical trial monitor
while also leveraging the quality of clinical trial outcomes overall.
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