Clinical studies (clinical research) are divided into two categories:

• Contract research: on commission from the pharmaceuticals industry
• Supported research: research-initiated studies with limited contributions from the industry/research groups

Norinnova Technology Transfer can attend to preparation of contracts concerning contract-based clinical studies at UNN which are financed in full or in part by an external source.

All externally financed studies should be reported to Norinnova immediately after the decision has been made to commence the study and the research protocol has been completed.

Norinnova requires the following:

• Research protocol
• Copy of the contract
• Copy of the budget
• Any manuals (lab, x-ray etc.)

Norinnova handles:

• Completion of the budget in consultation with the investigator and the service departments at UNN
• Entering into a contract with the contractor on behalf of UNN
• Entering into a contract with the service departments
• Coordination of the various service departments in the start-up phase
• Reporting the study to the local medical agency at UNN and the Research Management System at the Clinical Research Centre
• Following up inclusion/milestones
• Invoicing and follow-up finances
• Accounts / auditing
• Concluding with payment of the service departments

Any surplus from studies may be placed in a fund that Norinnova administers.
Administrative overheads to Norinnova are 18-20 % on studies that are fully financed by the pharmaceuticals industry. This is generally covered by the industry. In research-initiated studies, Norinnova charges administrative overheads of 10 %.

Relevant documents:

• Contract with the Norwegian Medical Association (NMA) and the Association of the Pharmaceutical Industry in Norway (LMI)
• The Health Research Act
• Research routines UNN

For more information, please contact Grethe Hoel, Advisor, Clinical Studies.