Conduct
During the trial, the hospital will invoice sponsor for tasks performed. Webpages and other information about the trial must be kept up to date.
Financial Follow-up
Twice a year (March and October), Inven2 sends a form (excel sheet) for trial activity reporting and information about the invoicing process to the Principal Investigator (PI). The PI/study nurse must register the patient numbers, fill in visit dates and procedures performed and return the form to Inven2. The sponsor will then be invoiced based on this information.
All payment from the sponsor goes into a study specific account at Inven2. Settlement of balances between Inven2 and OUS is governed by a separate service agreement.
Twice a year, based on the trial's earnings in the last period, Inven2 will make a distribution of income to all departments that have contributed to the study. Details can be found in the internal project accounts at OUS.
The PI can obtain information regarding the trial’s account by contacting the finance department in his/her division.
Reimbursement of Expenses
Inven2 is responsible for the payment of reimbursement to study participants for expenses related to the study and invoices the sponsor for the expenses. When the trial contract has been signed, the PI will receive a trial specific form for registering reimbursement claims. The PI signs the form to confirm that the expenses are related to participation in the trial, and is within the limits given in the agreement. If the sponsor is to cover expenses beyond what is included in the agreement, the PI is responsible for obtaining written acceptance and attaching this to the reimbursement form. The PI sends reimbursement forms with associated receipts attached to Inven2.
Patients participating in clinical treatment studies are entitled to reimbursement of travel expenses according to current rules, see Helsenorge.
Coverage of expenses beyond this must be agreed with the sponsor.
The OUS Website and Helsenorge
The Principal Investigator (PI) should send an email to post.kommunikasjon@ous-hf.no when the inclusion of new trial subjects ends.
The communication staff will then ensure that the study is moved from ongoing, recruiting studies on the Helsenorge website for clinical trials, to ongoing trials that have completed recruitment. In addition, the trial will be removed from the treatment pages on the hospitals' websites, but will still remain on the overview of clinical trials at OUS, with information that the trial is closed for inclusion.