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Inven2 Klinikk FAQ

What studies should Inven2 not handle

Inven2 does not handle hospital/invenstigator initiated studies without financial contribution from a commercial party.

What is a M-number?

The M-number is a unique project reference number created when the study is registered at Inven2. The M-number must be used as a reference in all correspondence regarding the study.

The Hospital uses the M-number in the referrals to other departments for study patients to ensure that any incurred study costs are. In that way, the departments know what procedures should be invoiced Inven2 and ensures that study costs are charged to the correct study account at Inven2.

Who archives the signed agreements?

Inven2 archives the signed agreement in a fire proof safe. Only one signed original is needed for Inven2/Hospital and this copy is archived at Inven2.

Scanned copies are always e-mailed to the signee at the Institution and the Principal Investigator for electronic filing.

Management of amendment to the agreement?

Amendments to the agreementmust be sent directly to the responsible Contract Manager at Inven2 or to «kliniskgruppe@inven2.com». To expedite this process, please add a short description of the need/rational for the amendment and please specify exactly that has been amended. If a study is extended, (extension study), and a new EudraCT number has been created, the extension study must be submitted together with a notification form for a new clinical study to Inven2.

What happens when the study is closed at the hospital?

Sponsor and/or Investigator must inform Inven2 as soon as all study activities has ended at site. Inven2 will then conduct the final invoicing of sponsor and settle the study account. 

Who is responsible for the internal approval of the study at the Hospital?

Principal Investigator is responsible for obtaining all relevant internal Hospital approvals before the study starts.