A workshop was held during the NRC-conference 2011under the title “Monitoring – The Nordic Network”. It aimed at establishing an opportunity to everyone engaged with quality assurance/monitoring of academic studies in the Nordic countries to meet and discuss areas of common interest. As an introduction to the workshop were outlined the complicated arrangements regarding the responsibilities of surveillance and planning of quality control of academic studies with investigators acting also as sponsors. People directly engaged with academic research (managers, study nurses or monitors) participated in the workshop. During the discussions it became evident that, if we wanted to facilitate and optimize the conductance of academic GCP-studies across borders in the Nordic countries, higher degree of collaboration and understanding between the Nordic GCP-units and other monitors is needed.

The different GCP-units and GCP-monitors working in the Nordic countries would definitely benefit from sharing experience regarding interpretation of GCP-requirements and how to spread knowledge of GCP to academic investigators. Thus, the conclusion of the workshop was clear. A proposal to the NRC was formulated to establish a network where people working with GCP in academic studies in the Nordic countries could meet and exchange experience as well as streamline certain procedures e.g. by creation of common templates for agreements, monitoring reports, etc. 

Another obvious idea would be to coordinate other activities such as GCP-courses, training of personnel, auditing and contact/lobbying of authorities.There was a general agreement that the new network should have been established as a part of NRC and thereby have been able to use the organizational advantages. The activities of the network should also have been coordinated with other ongoing activities within the Nordic countries, e.g. local ECRIN networks. 

Guideline for a coordinated GCP-monitoring of clinical trials in the Nordic countries

The aim of the guideline is to describe a coordinated approach to GCP monitoring of clinical trials within the Nordic countries. For trials conducted in more than one Nordic country the guideline will facilitate monitoring and will increase the quality of the monitoring process of the specific trial.

Guideline for a coordinated GCP-monitoring of clinical trials in the Nordic countries, version 5, 24.10.2017. 

Mapping the units in the Nordic Countries

Mapping the units in the Nordic Countries is one of the tasks that the network aims at accomplishing.

Initial mapping by country

How to become a member

If you are interested in becoming a member of the network, you are welcome to contact Birgitte Vilsbøll Hansen or to join our group the Nordic Monitoring Network on LinkedIn, or to attend the upcoming NRI-Conference.