1. Monitoring in Norway
Birgitte Lid Adamsen

2. Figure 1: Number of monitors in Norway25
monitors
Ålesund
Fredrikstad

3. Collaborations Standard Operating Procedures
Collaborates to monitor multi-center studies
Comparable price policy (advicing are free of charge )
Website:

4. Collaborations – cont.
Co-monitoring: Exchange experience and possible clarify the need for training
Each monitor should ideally participate in a co-monitoring visit every other year
National monitoring group: Two meetings a year:
At one of these meetings, The Norwegian Medical Agency (NOMA) attends

5. Collaborations – cont.
In multi-center studies, monitors monitor in each of their health regions. At the meeting (always): Discuss challengers and possible solutions, share useful information and share good tips
Next meeting: Discuss template monitoring reports
The purpose is to create a guideline describing how to fill out monitoring reports

6. The Norwegian Medical Agency
Trials with medicinal products
Total
Commercial sponsors
(pharmaceutical
industry)
Non-commersial (investigator-initiated) sponsors
Figure 2: The number of applications that commercial and non-commersial sponsors has sent to NOMA from 2006 – 2017

7. Clinical studies Status September 2018 96 % medicinal products
4 % medical devices
 Other intervention
Figure 3: Total numbers of clinical drug and medical device studies in Norway, except from Bergen and Ålesund

8. News

9. News
St. Olavs hospital (Trondheim): It is going to be established a CTU (Clinical Trial Unit): uncertain when it happens
University Hospital of North Norway (Tromsø): REDCap is approved as a data capture system

10. News – cont.
Østfold Hospital (Fredrikstad): It is going to be established a CTU (decided by the director of the hospital)
Interview of possible candidates for the position as research coordinator has started

11. Oslo University Hospital
CTU was established 1st of Sept. 2017, currently 31 employees
Three sections
Monitoring
Data Management
Health Economy, Project Coordination and PROM
PROM= patient-reported outcome measurements
PROM= patient-reported outcome measurements

12. Oslo University Hospital
Two special advisers:
GCP
Statistics

13. Dept. of Research Support and the CTU
Comparative medicine
Henrik Rasmussen
3 sections, RAD, UL, RH
Research Admin
Peder Utne
External funding
Clinical Trial Unit
Jon B Borgaard
Section
Monitoring
Elin Westerheim
9 staff
Section Data management
Cecilie Moe
8 staff
Section HE, coordination and PROM (PROMiNET)
Ellen Johnsen
11 staff
GCP/QMS/QA
Martha Colban
Statistics, collaborate OCBE
Inge Christoffer Olsen
OCBE
Arnoldo Frigessi
OCBE OUS
Morten W Fagerland
Dept. of Biobanking and Registry Support (from )
Dominic Hoff
2 teams: Biobanking and Reistry Support/ Medinsight
4 statisticians
OCBE= Oslo Centre for Biostatistics and Epidemiology.

14. Research Support at OUH
Facilitate research
Locally
Regionally
Nationally
Provide expert knowledge
Ensure infrastructure for large clinical trials of good quality
Eventually: Provide support for (almost) all stages of the research process from idea to publication

15. Do you have
any questions?

16. Focus areas – Challenges
Risk management, risk assessment and risk based monitoring
How should we satisfy the requirements of GCP R2? Tolerance limits? Can we do risk assessment in the same way?
On-site monitoring and centralized monitoring
How can monitor and data manager collaborate in an efficient manner?

17. Focus areas – Challenges cont.
Challenge: Monitor in Trondheim, data manager in Oslo – How to work efficiently?
Regulation 536/2014 on clinical trials on medicinal products and ISO Medical devices
Increasing interest from the investigators: Do we have all the standard operating procedures that we need? Do we have the knowledge to help the investigator? Need training.