Lifelong LEARNING 

New GCP diploma course at Atrium

April 2018

New GCP diploma course challenges the silo mentality

This very March a new version of our well-known GCP diploma course emerged. 25 course participants from hospitals, CROs and private pharma companies spent three days learning GCP legislation and guidelines with a new and essential focus on context and cross-functional understanding. The new approach aims to bridge the gap between professionals involved in clinical trials.

Programme Director at Atrium, Gitte Hornemann Møller, saw a need to rethink the way we teach Good Clinical Practice and therefore she established a working group that consisted of GCP professionals who saw the same need and wanted to contribute. 

The working group represented both the private and public sector as well as the full spectrum of educational practice and theory of applied knowledge. The group members were Jeanette Blom, GCP-Coordinator from the GCP Unit at Copenhagen University Hospital and Susanne Witzke, Competency Development Specialist at Trial Management Anchor at Novo Nordisk A/S.


A missing link between professionals

The initial reason for rethinking the GCP diploma course was, at some point, a frustration among course participants and sponsors. A frustration that was rooted in a missing link between professionals – in this case between study nurses and monitors in a clinical trial setting.

“We wanted to address this issue which was very much related to cooperation rather than to legislations and guidelines. We know that a lack of understanding between the two groups of professionals can have a direct impact on how effectively the clinical trials are carried out?,” says Susanne Witzke who is a member of Atrium’s Clinical Advisory Board and one of the course instructors.

During the past 12 years Atrium has offered two types of courses, one for study nurses and one for monitors, but since bridging the gap between professionals is part of the mission with the course the two groups of professionals now follow the same course.

“We have been on a mission to, on the one hand, take a totally new approach with the aim of adding context and a broader understanding of the dynamics within clinical trials for each role to better understand the cross functional dependencies. But at the same time, we had to make sure this did not happen at the cost of the professional content level, which is an area where we cannot lower our standards,” Susanne continues.


Bringing people together

The course in March was the first GCP diploma course with the new setup, but there are more to follow in the future.

“Now that we’ve had our first experience with the new course, I must say that it makes so much sense to bring people together. I’ve witnessed many “Aha” moments and it takes the learning experience to a new level when the course participants get the full picture of the process and understand not only what to do, but also why,” Susanne explains. “The response we’ve had from the course participants confirms that our approach is right. To be honest it requires much more from a planning and teaching point of view to build these bridges and facilitate the professional discussions that come up, but from a learning perspective the outcome equally impressive. So, it’s worth the effort.”


The future perspective

Legislations and guidelines can change, but rarely does. The way they are interpreted and how they are implemented are always subject for discussion and ever changing. Therefore, elements of the course will be new every time whereas the base content remains the same.

“The way we’ve redesigned the GCP diploma course allows us to ensure that both the formal training is covered and that the day-to-day situations they are applied into are considered. This is very much in line with a general ambition to challenge the silo mentality in life science and inspire everyone to look beyond their own professional area of responsibility,” Susanne wraps up.

Do you want to join the next GCP diploma course? Sign up now for the next course running from 17 - 19 September.