As part of the process leading up to a company’s decision regarding which countries and hospitals should be offered the opportunity to participate in a clinical trial, it is common to carry out a so-called feasibility, i.e. the company sends requests via its local representative to potential investigators to find out if the study may be relevant for them.
Participation in externally sponsored research must be authorized by the hospital.
Inven2 manages contractual and financial aspects of externally sponsored clinical trials in South-Eastern Norway Regional Health Authority.
When it has been decided that the study will be conducted by the site and a final protocol is available, the sponsor or sponsor's representative must report the study to Inven2 via an online form. Each study receives a unique project number (M-number). This will be used in all further correspondence with Inven2 as well as in contracts and invoicing.
It is important to contact the service departments early, in order for the sponsor to be able to find another supplier if the hospital does not have the capacity or opportunity to provide the required services. Requests must be detailed so that it is clear what needs to be done, how often, when the study starts, how long it lasts and how many patients will be included. Study protocol and other relevant documentation such as laboratory or procedure manuals should be attached to the request.
Contracts with the service departments must be in place before the study budget can be completed.
Once participation and prices are agreed, the trial budget can be prepared. Based on the flow chart in the study protocol, Inven2 sets up a customized budget template which is sent to the Principal Investigator (PI).
Inven2 is responsible for the contracting process with the client on behalf of OUS, including quality assurance of the contract and negotiations with sponsor regarding payment and other conditions. Agreement templates can be found on Inven2's website, but companies can also use their own.
Inven2 coordinates signing of the contract from the responsible person at the hospital (usually the department head), as well as from the PI confirming that he/she has read and understood the agreement.
It is a clear and distinct political goal that patients should have the opportunity to participate in new and experimental treatment (clinical trials). For that reason, it is also desirable to cooperate across national borders by arranging for patients to be given the opportunity to participate in trials carried out abroad. A prerequisite for this, however, is that the costs of such participation are agreed in advance and that the responsibility of the patients for any unforeseen events is handled and clarified in separate agreements.
The pharmaceutical industry (LMI) and Medtek Norge (trade organization for health and welfare technology) have entered into similar agreements with all the regional health authorities in Norway, that establish a binding framework for cooperation including clinical trials.
The national coordinating investigator (NC) is always the applicant for the REK (Regional Ethics Committees).
Fill in the online form "Melding til personvernombud og informasjonssikkerhetsleder". You need to upload the study protocol, a copy of the REK application and the subject information/informed consent form, as well as other relevant attachments. You will also be asked to provide login links to any electronic questionnaires/ eCRF solutions, if applicable, in order to test whether the web solutions meet information security requirements.
All prospective clinical trials conducted at OUS must be registered in ClinicalTrials.gov prior to inclusion of the first patient. In industry sponsored trials, the registration is done by the sponsor.
Clinical trials and rehabilitation studies that may affect the treatment course of the research participants and which are open to inclusion, or where REK approval is obtained and the start date is set, must be published on the hospital's website and on helsenorge.no.
See Registration and reporting for information regarding what to register and how.
A manual for conducting industry sponsored clinical trials (in Norwegian) has been prepared for OUS. The manual can be downloaded here.
Template (folder structure - in Norwegian) for storing electronic documentation can be found here: E-study archive.
