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. 12-01-201912-01-201912-01-201912-01-201912-01-201912-01-201912-01-201912-01-201912-01-201912-01-201901-05-2018

GCP-units Collaboration Steering committee Monitoring of multicentre trials Audit Standard Operating Procedures website www.gcp-enhed.dk 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 12-01-201912-01-201912-01-201912-01-201912-01-201912-01-201912-01-201912-01-201912-01-201912-01-201901-05-2018

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

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.

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

NORM: Copenhagen 2012