Costs for activities related (but not limited) to the following must be included as per Attribution of costs for research and development (AcoRD):
- sourcing, manufacturing and distribution
- QP certification (incorporating importation and regulatory requirements)
- host site pharmacy set up, close out
- host site IMP management of the trial
Excess treatment costs (ETC) (including negative ETCs) must be calculated at this stage. Access to the IMP at the end of the trial/exit strategy for the participants should also be clarified at this stage and the detail included in patient information leaflets for provision during the consent process.
Consideration at this point should be given for any planned reimbursements to sites related to medications and placebos used in the trial.