Guidelines for a coordinated GCP-monitoring of clinical trials published

May 29, 2015
NTA's project on monitoring of clinical research recently released a guideline for a coordinated GCP-monitoring of clinical trials in the Nordic countries. The aim of the guidelines is to describe the prerequisites required for collaboration within the Nordic GCP Units specifically associated with the monitoring of academic trials.

In the Nordic countries GCP Units linked to hospitals and universities have a long standing tradition of working with monitoring and quality assurance regarding academic clinical trials conducted simultaneously in the Nordic countries. To strengthen the collaboration between the Nordic GCP Units Nordic Monitoring Network (NORM) was established. This guideline has been produced by NORM.

For trials conducted in more than one Nordic country the guideline will facilitate monitoring and improve the quality of the monitoring process of the specific trial.

Read the guidelines

Written by:

Martha Colban, Head of department, Clinical Research Support at Oslo University Hospital, Norway
Ingunn Heie Anundskås, Consultant, Haukeland University Hospital, Norway
Satu Nikander, Research Coordinator, Clinical Research Institute HUCH Ltd, Finland
Lena Nybond, Research Manager, Turku University Hospital, Finland
Lotta Lind Åstrand, Research coordinator, Research Coordinator, LARC, Sweden
Lena Liliebladh, Clinical Trial Manager, Lund University Hospital, Sweden
Charlotte Calov, Head of the GCP-unit, Odense University Hospital, Denmark
Annette Jørgensen, Head of the GCP-unit, Aalborg and Aarhus University Hospitals, Denmark

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.