The page Oppdragsstudier (externally funded clinical trials) describes the budget process within the Hospital.
Inven2 will construct a study budget template, tailored to each individual study, and sent it to the PI to act as a budget framework. The PI is then responsible for estimating the actual study budget and obtaining acceptance/prices from any other hospital departments that must be involved in the study.
Total study budget
The total study budget comprises of (1) the visit cost per patient, (2) times the estimated patient recruitment goal, plus (3) other visit-independent costs like preparatory work, administrative costs, travel reimbursements, conditional procedures and start-up fees. The hospital pharmacy is not a part of the hospital. We therefore recommend the sponsor to have a direct agreement with the pharmacies for the trials.
Cost estimates for time study personnel spend during a given visit, or sometimes a procedure, is based on standard hourly rates. These hourly rates are fixed for all clinical trials at these hospitals and ensures both transparency and predictability in regard to the estimated study cost.
In addition, some services at the hospital have a standard rate, making it easier to calculate overall cost at an early stage. This is common for laboratory services, radiology and some other departments where the cost per service can be easily standardized. For other services, where it is more difficult to give an upfront estimate, the price is calculated on a case by case basis.
The trial start up fee is compensation for time spent in the planning phase of the trial at site. Some departments at the hospital, like the lab and the radiology department, have a fixed start up fee for all trials.
The cost of external storage of study documents after study closure must be compensated by sponsor.