Clinical Trials
Clinical research is an integrated part of the daily activities in the hospital departments in Region Zealand and many departments have experience with collaboration with industry-partners regarding clinical research.
The hospitals in Region Zealand hosts also the full range of non-clinical departments with possibility of delivery of services such as scans, pathology analyses, handling and analyses of blood samples or handling of investigational medicinal products. Intensive care units are available at the hospitals in Køge, Roskilde, Slagelse and Nykøbing.
Approvals
All clinical trials need to have approval from the national competent authority (Lægemiddelstyrelsen) and from one of the Danish Ethics Committees. These submissions occur in parallel.
The Sponsor in collaboration with the National Coordinating Investigator ensure submission to the selected ethics committee.
The Ethics Committee for the Capital Region consist of several committees. The meeting dates are displayed here.
The Ethics committee in Region Zealand meet every second month. Submission timelines are three weeks in advance of the meetings. Read more and see meeting dates and timelines on the homepage of Region Zealand.
After obtaining of approval from Lægemiddelstyrelsen and the Ethics Committee, and after final contract is in place, the hospital management need to approve the trial. Target KPI for this last approval is max. five days.
Contracts
All contracts for sponsored clinical trials will undergo legal review. The Investigator, the Head of Department and representative from hospital management will sign the contracts.
Source and Study Documentation
The hospitals in Region Zealand work with Electronic Medical/Patient Records (Opus Clinical/Opus Medicin), and from ultimo 2017 with Sundhedsplatformen. Opus has an electronic audit trail and processes for back up is in place.
Source documents are accessible in electronic format for inspectors, auditors and monitors via allocated intermediate personal access codes.
Facilities are available for long term storage of study documentation (payment is part of study budget)
Equipment
The Medico Technical Department in Region Zealand has procedures for service level of different equipment types in the region.
IT
All sites in Region Zealand has both high-speed internet access and wireless internet access, and there are internal firewalls.