Medicinal product management in the implementation stage

Receipt, labelling, accountability etc of IMP should be managed, see SOP Legemiddelhåndtering ved gjennomføring av kliniske utprøvinger (Norwegian). Before trial database lock, IMP should be accounted for, see SOP Legemiddelhåndtering ved avslutning av kliniske utprøvinger (Norwegian), point 4.1. When IMP is not a shelf product, there should be IMP reconciliation and destruction should be documented.

Studiemedisin – totalregnskap (Norwegian) / Investigational medicinal product – drug reconciliation

Destruksjonslogg (Norwegian) / Destruction of investigational medicinal product