Work Package 5 Monitoring of Clinical Research

The following project on monitoring of clinical research has been awarded funds by the NTA board:

Project Period: 01.01.2014 – 31.12.2014

Project Leader:Annette Jørgensen, Head of Department, The GCP-unit at Aalborg and Aarhus University Hospitals, Aarhus University, Department of Clinical Medicine

Project update 2.12.2015

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

Project summary

The aims of the project are to strengthen the collaboration between the Nordic GCP-units and to increase the quality of and facilitate the monitoring process of clinical research. We have pointed out four main issues with the following deliverables:

1)    Mapping of Nordic resources for monitoring.

2)    Guidelines for a coordinated GCP-monitoring of clinical trials describing the cooperation between the Nordic GCP-units and the sponsor of a trial.

3)    Guidelines for developing a monitoring plan with a risk-based approach.

4)    Template for a monitoring plan.

 

Background

The Nordic Monitoring Network (NORM) is a network for persons working within the field of monitoring and quality assurance of academic trials in the Nordic countries. This initiative was started in 2011 and formalised in October 2012. In the network we have the advantages of sharing a common cultural understanding and similar competence levels. Strengthening of the cooperation between the Nordic GCP-units has been considered as a step forward in the direction of getting a similar quality assessment of clinical trials conducted in the Nordic countries. Most experience in NORM is with in monitoring of trials with medicinal products but the guidelines and procedures developed by NORM may be applied to other clinical investigations as well.

Members of the network plan to meet every year at the NORM meetings and to share information and discuss issues related to monitoring in a closed group at LinkedIn, right now with 47 members. In each country employees from the GCP-units participate in national networks with regular meetings and collaboration. These existing networks make it possible to implement Nordic initiatives at the national level.

The members of the project group are all members of the steering committee of NORM. In addition Halla Sigrún Arnardóttir, Landspitali University Hospital is Iceland`s representative of NORM and she will have the possibility to comment on all documents.

So far the work in NORM has been carried out in-kind and members of the steering committee and members of the network have covered all costs by themselves. The possibilities to continue and to further develop this work are very much dependent on funding why we hope for a positive response from NTA.

The Nordic Trial Alliance (NTA) is a three-year pilot project running from 2013 to 2016, funded by the Nordic Council of Ministers and NordForsk.