Monitoring

For trial monitoring, please contact the research support unit in the relevant health region:
Southern and Eastern Norway Regional Health Authority (CTU-OUS)

Contact: Elin Westerheim
E-mail: kliniskforskningsstotte@ous-hf.no

Western Norway Regional Health Authority

Contact: Anne Mathilde Henden Kvamme
E-mail: anne.mathilde.henden.kvamme@helse-bergen.no

Central Norway Regional Health Authority

Contact: Ann Jorunn Sandstå
E-mail: ann.j.sandsta@ntnu.no

Northern Norway Regional Health Authority

E-mail: kliniskmonitor@unn.no

NorCRIN is part of the Nordic Monitoring Network: NORM

Pricing of monitoring services provided by the research support units

For interregional trials, it is recommended that monitoring be distributed to the research support units at Haukeland University Hospital, St. Olav’s Hospital/NTNU, University Hospital of North Norway and Oslo University Hospital. For complex trials with a small number of patients, it may be relevant to limit the number of monitors.

The prices are based on an hourly rate of NOK 800 (last updated 18 December 2019). The hourly rate is adjusted in accordance with the consumer price index (CPI) every year. Prices must be considered as indicative, and may vary from trial to trial depending on the complexity of the trial. Invoicing will be based on time spent.

Costs associated with monitoring:
Reading the protocol

Price: NOK 4,800
Unit: per monitor

Travel expenses incl. daily allowance

Unit: per journey
Framework: as per the Norwegian Government’s travel allowance regulations

Preparing a monitoring plan in collaboration with the national coordinating investigator (NKU*)/project manager

Price: NOK 4,800
Unit: per project

Initial visit

Price: NOK 8,400
Unit: per centre
Framework: the price includes preparatory and follow-up work. Any travel time and travelling expenses will be charged separately.

Monitoring visits

Price: NOK 12,000
Unit: per visit
Framework: the price includes preparatory and follow-up work. Any travel time and travelling expenses will be charged separately.

Making trial folder or pharmacy folder

Price: NOK 1,600
Unit: per folder
Framework: only done by Haukeland and St. Olav

*NKU: National coordinating investigator
Travel time will also be charged if it exceeds the normal working day (7.5 hours).

The following tasks are offered free of charge:
General advice regarding GCP, protocol-writing, monitoring etc.

For whom: NKU/project manager
Framework: Up to 30 hours

Preparing cost estimate

For whom: NKU/project manager

Preparing a collaboration agreement including budget

For whom: Principal investigator(s) (HU**) in own health region

Attendance at start-up meeting, possibly including presentation of the monitoring; optionally other trial meetings

For whom: NKU/project manager, optionally foreign sponsor
Framework: Up to one meeting per year. Any travelling expenses must be covered by the project.

Facilitating a risk assessment of the trial and writing a summary

For whom: NKU/project manager
Framework: Once during the planning stage of the trial.

**HU: Principal investigator