Monitoring

The responsibilities 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.

The monitor’s 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 performance.

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.

Information has been referenced from Principles of Clinical Research, 2001.