Upon signing the contract, the management and administrative control invoice will be issued, which has a fixed and non-refundable amount of € 1.110,51 (VAT not included). This amount is independent of the Ethics Committee evaluation fees and its charge is not conditioned on the effective conduct of the study or its approval by the CEI / CEIm or the AEMPS.
In Andalusia, the exemption of administrative management fees can be requested in studies sponsored by sites and foundations integrated within the Public Health System of Andalusia (SSPA) and in research that meets all the criteria of the non-commercial clinical trial definition contained in the RD 1090/2015. If these circumstances occur, the fee exemption form (Modelo de solicitud de exención de gastos de gestión y control administrativo) must be submitted together with the study contract and budget.
Likewise, the amounts to be invoiced will be monitored periodically based on patient recruitment, patient visits, and corresponding monitoring activities.