1. Denmark Annette Jørgensen Head of Department
Thank you for given me the opportunity to tell you a little about what we are doing in Denmark
Præsentation
By this meeting in NORM we are doing bridge-building. Want to draw your attention to these nice fotos of Storebæltsbroen. The brigde between Funen and Zealand. All the employees from the three GCP-units meet every year for a workshop. Last year we went on a speciel trip to the island Sprogø, which connects the two parts of the bridge. The fotos are taking here.

2. GCP-units Collaboration Steering committee
Monitoring of multicentre trials
Audit
Standard Operating Procedures
website
Comparable price policy
GCP-unit: 100 hours for free for each trial
11employees
14 employees
Denmark: 3 GCP-units connected to the University Hospitals. Each unit covers the hospitals and researchers in geographical areas. These areas correspond to the regions in Denmark.
Organizationally independent but have a close collaboration.
Coordinated by a Steering committee, that includes the management from each unit.
Monitoring of multicentre trials. The monitoring will be coordinated by sponsors GCP-unit and each unit do the monitoring of the participating hospitals in their regions
Audit: A trial from a sponsor in my region will be audited by auditors from Odense and Copgenhagen
Harmonized Standard Operating Procedures and report forms for monitoring and audit and also a SOP for working together
Website: Information, guidances, checklists and forms for the researchers
Comparable price policy:
A large part of the budget for each GCP-unit is financed by the owners, universities and regions. Each GCP-unit can offer a trial 100 hours for free. If that is not enough the sponsor must pay for the remaining hours.
7 employees

3. Trials With medicinal products, the Danish Medicines Agency
All
Sponsor-initiated
Investigator-initiated
This slide show the number of new trials notified to the Danish Medicines Agency each year.
You probably recognize the development with a decreasing number of sponsor initated trials. In DK Since 2010 the number has stabilized/increased. The same devopment has not been seen in the investigator-initiated trials
Årsrapport 2017: Kliniske forsøg med lægemidler på mennesker

4. NEW Trials, GCP-UNITs A trial is registered in sponsors ”GCP-unit”
94% medicinal products
5% medical devices
<1% other intervention
20-25 % multicentre trials monitored
in a collaboration between 2 or all 3
GCP-units
The number of new trials in each GCP-unit. Some of these trials are multicentre trials, but here they are only registered in sponsors GCP-unit.
The reseachers are not required to use the GCP-unit. They are allowed to arrange monitoring in another way. But as the number of trials is almost the same as the number notified to the medicines agency we probably see most of the trials
<1% other intervention: GCP is not required by wanted by the researcher.

5. Focus areas - challenges
Regulation 536/2014 on clinical trials on medicinal products
Large multicentre trials (20 sites, 1500 trial subjects)
Risk management, risk assessment and risk based monitoring
Monitoring strategy that combines centralized monitoring and on-site monitoring in an effective manner
Audit, involving and motivating sponsor in the planning of an audit
Collaboration with international sponsors who want to run trials in Dk
Regulation: expect to be implemented 2019
Large multicentre trials: Intensive Care. Challenging because it is very important to choose the right monitoring strategy to get the best data and protect the trial subjects without using too many resources.
Risk management, risk assessment and risk based monitoring
Now the risk assessment is done by the monitor in collaboration with the sponsor. Next step is to motivate sponsor to do a risk assessment and decide how to control the risks - just like the sponsor design the protocol.
Centralized monitoring is becoming a possibility with increased use of electronic CRFs
Audit: So far the GCP-units have selected the sponsor, the trial and focus of an audit. Right now we might still point out the sponsor, but we want the sponsor to decide what should be the focus of the audit
Collaboration with international sponsors

6. NORM: Copenhagen 2012