of the monitor’s role are well documented in the E6 - ICH
GCP Guidelines. However, monitors should also comply with the
local regulations and with the SOPs of the Sponsors / CROs involved
in the study procedures. Potentially, there exists a large body
of documentation of which the monitor must not only be aware but
also have a sound working knowledge.
role is one in which “multi-tasking” is the norm.
There is a responsibility not only to ensure that all study aspects
are performed correctly according to all regulations and guidelines,
together with any applicable local requirements, but also to cultivate
good relationships, both with internal departments and with the
study site staff.
A positive relationship
with the study site is vital for maximizing co-operation and for
ensuring the smooth running of the clinical study. Starting with
the very first visit, it is essential to develop a solid working
relationship with the research team, and particularly with the
research nurse and the clinical trials pharmacists, since these
are the individuals at the study site who are also likely to be
involved with the day-to-day running of the study.
This can make the difference
between a successful study and one that is hampered by poor execution
and documentation. Effective communication between all involved
is essential and the monitor has a pivotal role, often having
to display consummate political skills to ensure optimal study
We at Consortium
Clinical Research, operate as the strong link
between the two stake-holders of a clinical study - the sponsor
and the investigator and ensure that the smooth conduct of the
study at each site (be it in metros / in smaller towns) is maintained.
As observed, some of
the domestic / international Sponsors also face logistics problems
of devoting man-power to travel across the country as per their
monitoring plans and perform the monitor’s responsibilities
at their level best; we extend our arms to service you in these
types of situations as well with our in-house trained monitors.
has been referenced from Principles of Clinical Research, 2001.