Documentation of the investigational medicinal product

SOP LM 2.03 Dokumentasjon av utprøvningspreparater (Documentation of investigational medicinal products)

It is helpful to use a checklist.

  • Some documentation is included in the application to the authorities:

See SOP LM 2.04 Søknadsprosess, godkjenninger og oppstart (Application process, approvals and start-up)
If an investigational medicinal product does not have marketing authorisation, an Investigator’s Brochure (IB) must be attached to the application to the Norwegian Medicines Agency. If you receive an IB from another party, you can check that all the points are included (see checklist). If an investigational medicinal product is to be blinded, see SOP LM 1.04 Randomisering, blinding og avblinding (Randomisation, blinding and unblinding).

  • Some documents must be prepared before the start of the trial:

The investigational medicinal product must be ordered by the investigator (see example of requisition).
Arrangements must be made to ensure that the investigational medicinal product is stored in accordance with specifications; Template Temperature log can be used.

An inventory must be kept of the investigational medicinal products. Three variants follow:

Mal legemiddelregnskap – lagerbeholdning, pakninger med ID-nummer (Template Drug accountability form – inventory, packs with ID numbers)

Mal legemiddelregnskap – lagerbeholdning, felles lager unummererte pakninger (Template Drug accountability form – inventory, shared inventory unnumbered packs)

Mal legemiddelregnskap – ikke lagerbeholdning, markedsført legemiddel varierende leverandør (Template Drug accountability form – not inventory, marketed medicinal product from varying suppliers)

In addition, a reconciliation must be prepared and destruction must be documented. This is the case if off-the-shelf products from pharmacies are not used.

Investigational Medicinal Product – Drug Reconciliation

Destruction of Investigational Medicinal Product