The new annex contains all the important information on the unit costs for clinical studies.
Changes in the possibilities of using unit costs for clinical studies, the modifications concern:
- The introduction of the possibility to use different reimbursement methods (actual or unit costs) for the different categories of eligible costs included in the Commission decision;
- The definition of the conditions under which the unit costs can be modified during the implementation of the action;
- An update of the scope of the decision by mentioning the new Clinical Trial Regulation EU No 536/2014 and more consistent use of the term ‘clinical study’;
- More consistent use of the term ‘patient or study participant’, thereby taking into account that healthy volunteers (in accordance with EU rules and international practice) take part in certain clinical studies;
- More consistent use of the terms ‘beneficiaries and third parties’.
Modifications No. 1 and 2. introduce significant additional flexibility into the use of these unit costs, which will facilitate the use of unit costs for clinical studies:
- Applicants can now decide for most cost items whether they want to be reimbursed on the basis of unit costs or actual costs. Only for the costs of personnel directly assigned to the conduct of clinical studies, each beneficiary may only choose one form – unit costs per patient or actual costs – with the exception of personnel costs for horizontal tasks, such as study monitoring or study coordination, which can always be charged as direct costs.
- The rules now specify that the unit costs can be amended (through a formal amendment) when changes in the protocol or errors occurred in the identification of costs recorded in the beneficiary’s certified or auditable accounts for year N-1 or in the application of the methodology to calculate these unit costs.
Commission Decision in the Participant Portal