1. FINLAND Leena Partanen Study Monitor
Clinical Research Institute HUCH Ltd
NORM Meeting Copenhagen

2. Organisation of Academic Monitoring
Area km²
5,5 million inhabitants
5 University Hospitals
Main responsibility for monitoring of academic trials
In addition freelancers and private companies

3. Helsinki University Hospital
Clinical Research Institute HUCH Ltd
Fully owned by Helsinki and Uusimaa Hospital district
In addition few trials monitored by freelancers
1,5 monitors for academic trials
One part timer
Plans & Agreements, invoices
43 academic trials
27 on going, 7 about to start, 9 in process
Majority cancer trials
Trials monitored in all university areas
Majority in Helsinki University Hospital

4. Tampere University Hospital
3 monitors
1 full time, 1 half time and 1 part time
30 academic trials monitored
53 sites
Trials monitored in all university areas
Several multinational studies

5. Turku University Hospital
Turku Clinical Research Centre (TurkuCRC)
1 monitor with also other responsibilities
Other professionals monitoring randomly
Currently 8 academic trials monitored
Operating mainly in Turku

6. Kuopio University Hospital
Own monitoring activities are being initiated
1 monitor in training
Currently monitoring of academic trials is carried out by monitors of the other University Hospitals or private companies
Since monitoring of academic trials is organised by investigators themselves, precise numbers of monitored academic trials are not available

7. Oulu University Hospital
1 study coordinator who is responsible also for monitoring
Other responsibilities include new CTAs and invoicing
Also acting as a study nurse in a few trials
Currently 8 trials monitored
All monitored trials in Oulu University Hospital
In addition some trials monitored by private companies
Plans to start a centralized research unit
Currently medical spesiality areas are operating quite independently in organizing their research projects

8. Current Topics Development: Challenges:
Strengthening the national monitoring network and cooperation
Monitoring education 2017
Updating the common shared monitoring tools and templates
Development of research units and monitoring inside university hospitals
Challenges:
Budgeting: Monitoring is payed by the investigators
Increasing amount of monitored trials due to increasing awareness of the need of monitoring
Increasing amount of more complicated multinational, multicenter trials
Implementation of GDPR