Nordic Monitoring Network

Aim of the Network

• To offer a coordinated GCP-monitoring of Nordic academic trials with medicinal products
• To make the Nordic countries a more attractive place to conduct clinical trials
• To increase the level of GCP-knowledge amongst academic researchers in the Nordic countries and thereby increase the quality of drug research

 Tasks of the Network

• To map all units that offer monitoring of academic trials with medicinal products in the Nordic countries
• To organize a system of coordinated monitoring of multinational trials in the Nordic countries
• To share knowledge and experience
• To offer audits
• To help establishing new monitoring units

Members of the board:

Denmark
Annette Jørgensen (contact person)
The GCP-unit at Aarhus University Hospital
E-mail: This e-mail address is being protected from spam bots, you need JavaScript enabled to view it Telephone: +45 78413950
www.gcp-enhed.dk  

Finland
Lena Nybond
Turku Clinical Research Centre
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Telephone: +358 (2)3133588
www.turkucrc.fi  

SwedenLena Liliebladh
FoU-centrum Skåne
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Telephone: +46 46177966 
www.skane.se/foucentrum  

Norway
Dag Grønvoll
Centre for Clinical Research/Education,
University Hospital of North-Norway
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Telephone: +47 77755856

Iceland
Halla Sigrún Arnardóttir
Clinical Trial Unit
National Hospital Iceland
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Telephone: +354-825-5011

To become a member of the network:
If you are interested in becoming a member of the network you are welcome to contact Annette Jørgensen or to join our group “The Nordic Monitoring Network” on LinkedIn.   

Monitoring of academic clinical trials with medicinal products:
Tasks of the network are to map all monitoring units and to organize a system of coordinated monitoring of trials with medicinal products in the Nordic countries. This work is not finished yet but if you need help for monitoring please contact the board member in your own country.

Meeting dates: 
1st meeting, NRC-conference in May 2012 (Workshop C )
2nd meeting, Copenhagen October 2012
3rd meeting, NRI-conference May 8th 2013
4th meeting/workshop: Malmø, October 2013

 

Background

At the NRC conference 2011 a workshop was held with the title “Monitoring – The Nordic Network” with the aim of 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 the often very complicated arrangements regarding the responsibilities of surveillance and planning of quality control of academic studies with investigators acting also as sponsors, were outlined. Only people directly engaged with academic research (managers, study nurses or monitors) participated in the workshop and during the discussions it became evident, that there was a need for a higher degree of collaboration and understanding between the Nordic GCP-units and other monitors, if we wanted to facilitate and optimize the conductance of academic GCP-studies across borders in the Nordic countries.

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 very clear and formulated as proposal to the NRC to establish a network where people working with GCP in academic studies in the Nordic countries could meet and exchange experience, but also streamline certain procedures e.g. by creating 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 be established as a part of NRC and thereby be able to use the organizational advantages. The activities of the network should also be coordinated with other ongoing activities within the Nordic countries, e.g. local ECRIN networks.