Submit new clinical study

Our web-based ‘Research Information Form’ must be filled in in order to submit a new industry-sponsored study to Inven2. The submitted form initiates the agreement and budgeting process at Inven2 and at the hospital.

See guide to the notification form below

Guide to the notification form

Who should submit the study?

The sponsor or a representative of the sponsor (Contract Research Organisation (CRO)) is responsible for submitting the study to Inven2.

When should the study be submitted?

As soon as participation in the study at the site is verified by the industry and the protocol is finalized.

An application for approval of the trial must be submitted to the Norwegian Medicines Agency and the Regional Committee for Medical and Health Research Ethics (REK), or the submission of an application for approval must be planned in the near future.

Please note that we prefer that the study is submitted to us at the same time as the trial is submitted to the Norwegian Medicines Agency and REK for approval. The approval process and agreement process should be carried out in parallel. Waiting for approvals before initiating the agreement process will prolong the study start up timelines.

What should be registered in the notification form?

All fields that are relevant for the study and all fields marked with red in the form must be filled in.

The budget process at the hospital depends on the information provided in the form. Information and clarifications regarding the study conduct and procedures must be provided in the form, i.e. who does what, will speed up the budgeting process at the hospital.

What must be attached to the notification form?

Study protocol (electronic version)
The study protocol is mandatory. Inven2 will not initiate the agreement and budget process until the final version of the study protocol is ready.
If the protocol is updated during the process, the latest version must be sent to us.

Operational manuals (lab, radiology etc.):
Documents that have not been submitted at the time of notification, must be sent at a later date. Several of the departments that perform various procedures will not be able to provide feedback on capacity and price until the manual(s) is (are) available.

Proposal for agreement and budget:
A proposal for an agreement for the study can be sent at a later date if it is not ready when the study is submitted.

Other:
Other documents or information that can be of help to Inven2 when submitting the study should be attached.

Involvement of hospital pharmacies

The sponsor must register whether the hospital pharmacy will be involved in the study or not, in the form.

For more information about the agreement process relating to the hospital pharmacy, see here.

Processing times at Inven2

The sender will receive automatic receipt once the notification form has been submitted.

Within seven days of submitting the notification form, the sponsor’s contract negotiator will receive an email with the following information:

  • Reference number: Each study will be given a unique project number (M number). This reference must be used in all subsequent correspondence with Inven2 regarding the study, agreement and invoicing
  • The name and contact details of the person responsible for the agreement at Inven2
  • Information about further process in relation to budgeting, trial agreement and pharmacy agreement

Within seven days of registered receipt of the completed notification form, Inven2 sends information about the budget process and a trial-specific document for budgeting to the investigator and the study team at the hospital.

Within 14 days of receiving the agreement proposal, Inven2 will provide feedback on the legal text of the agreement to the sponsor.