When a hospital pharmacy is to participate in a clinical trial, a separate agreement must be entered into between the hospital pharmacy and the clinical trial sponsor.
One of the following agreement templates must be used for this agreement:
- Inven2’s template for the framework agreement with the Sykehusapotekene Health Trust: Master Pharmacy Agreement
- Inven2’s template for agreements on individual trials with hospital pharmacies: Pharmacy Agreement
Inven2 is responsible for negotiating the legal part of the pharmacy agreement on behalf of Hospital Pharmacy Enterpise South-Eastern Norway.
Each hospital pharmacy is responsible for clarifying the tasks of the pharmacy and the price of these services.
- In the notification form to Inven2, the sponsor must provide information about whether the pharmacy is involved in the trial, including import permission.
- Inven2 initiates the process for the pharmacy agreement and informs the sponsor of the next steps:
- The sponsor fills in the relevant agreement template and sends it to Inven2
- The sponsor clarifies the tasks and price directly with the pharmacy’s contact person
- In multi-center trials in South-Eastern Norway Regional Health Authority, only one of the involved hospital pharmacies will be responsible for clarifying the pharmacies tasks and the price of their services.
These tasks and prices will apply to all hospital pharmacies involved in the trial
- The hospital pharmacy and the sponsor sign the agreement. Inven2 is not involved in the signing process.
For more information: sykehusapotekene.no/fag-og-forskning/forskning/kliniske-studier