Clinical Research Unit
The Site was formalized in 2002 and has expanded steadily with respect to both numbers of Clinical Trials as well as the size of staff.
As of May-2017 the Site Staff includes 1 Senior Study Coordinator, 1 Manager, 7 Study Coordinators (SC), 1 Laboratory Coordinator. Currently, 75% of site personnel are self-financed.
The staff is continually updated in the latest developments in running clinical trials through formalized training including programs within ICH-GCP, IATA along with trial-specific and more commonly used EDC Systems (Electronic Data Capture). Needless to say, the personnel have a thorough and comprehensive knowledge and know-how within the quality assured health system of Aarhus University Hospital.
Clinical Trial experience includes:
- Commercial (Phase Ib – Phase IV) Ongoing 10-20 enrolling trials
- Non-Commercial (Phase Ib – Phase IV) Ongoing 10-20 enrolling trials
Besides the role as national coordinating site the office also accepts the role as a national core site.
Recent five-year Audit/Inspection activities include 3 Sponsor Audit (Sep-2014, Dec-14, Nov-16) and 1 DHMA/GCP Inspections (Dec-2014). Importantly, no major systematic errors have been detected.
The Site adheres to the principles of efficient and high-quality clinical trial management but has in addition to this developed and implemented several initiatives to improve local procedures, counting initiatives within these organisational areas:
- Strategically: ‘Appoint and assign principles’. By specialising the Site Staff, each Clinical Trial is allocated to Study Coordinators based on their knowledge and experience within the actual field of haematological diseases and knowledge with the current investigational product.
- Tactical: Annual ‘progress meetings’ with collaborating departments ensure continuous exchange of new concepts, ideas and financial topics..
- Operational: ‘Assisting tools’ such as Standard Operating Procedures, flowcharts and guidelines support the daily Clinical Trial management. Off-Site, the ‘Introduction Letter’ and the budget assisting documents have proven helpful in facilitating the initial relations between Site and Sponsor/CRO.
The Department of Haematology has a long tradition of participation and leadership in a number of National, Nordic and International collaborative clinical trial study group, such as Nordic Lymphoma Group (NLG), Acute Leukaemia Group (ALG) and Nordic Myeloma Study Group (NMSG).