Nordic Monitoring Network
Nordic Monitoring Network (NORM) is for everyone working within the field of monitoring and quality assurance of academic clinical trials with medicinal products in the Nordic countries. Ongoing tasks of the network include mapping all monitoring units and organizing 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.
Aim
- 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
- 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
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 increase the quality of the monitoring process of the specific trial.
Guideline for a coordinated GCP-monitoring of clinical trials in the Nordic countries
Mapping the units in the Nordic Countries
It is one of the tasks that the network aims at accomplishing (see the list above). The results of initial mapping are available here.
Members of the board
Annette Jørgensen, Denmark, (contact person)
The GCP-unit, Aarhus University Hospital
E-mail: [email protected]
Tel. no.: +45 78 41 39 50
Lena Nybond, Finland
Turku Clinical Research Centre
E-mail: [email protected]
Tel. no.: +358 (2)3 13 35 88
Lena Liliebladh, Sweden
FoU-centrum Skåne
E-mail: [email protected]
Tel. no.: +46 46 17 79 66
Dag Grønvoll, Norway
Centre for Clinical Research/Education, University Hospital of North-Norway
E-mail: [email protected]
Tel. no.: +47 77 75 58 56
Halla Sigrún Arnardóttir, Iceland
Clinical Trial Unit, National Hospital Iceland
E-mail: [email protected]
Tel. no.: +354 8 25 50 11
How to become a member
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, or to attend the upcoming NRI-Conference.
Previous meetings
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 as well as 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.