Building of any site budget is a complex task that can conventionally be divided into three parts: 1. Visits/procedures costs, 2. Conditional procedures and 3. Site fees – the last two are usually called invoiceables. Nowadays, there are several widely used systems that can generate site budgets quite quickly, yet they cannot substitute a ‘human’ professional since budget creation requires not only a good knowledge and understanding of the protocol, but also adjustments at site level.

If it turns out to be clear for visits/procedures costs, it can be more complicated when it comes to invoiceables. Sponsors reasonably want to know how much they should invest per site and site shall provide as precise estimation as possible.

To ensure such estimation, ideally there shall be a cap for the number of invoiceable fees per site. The cap is evidently clear for one-time fees as start-up fee or close-out fee.

The cap can be pre-set by the Sponsor for screen failures, patient travel reimbursement and other fees that can be regulated or limited by the Sponsor.

However, there is a few fees for which the cap can be hardly defined and capping such fees can be a pure guesswork. The list of such fees can be very long depending on ‘complexity’ of the study. Here are just a couple of evident examples: pregnancy test fee (for studies with participation of subjects of any gender) – we never know how many tests will be performed, CT/MRI (as conditional procedures) – we cannot predict how many subjects will need to undergo these procedures, protocol amendment fee, etc.

Can we ‘cap incapable’? The answer can be a paradox: ‘We cannot, but we should’. It is important to highlight to the Sponsor that some fees cannot be capped, but the cap should be negotiated with the sponsor. Some sponsors impose a cap with a note that the cap can be overstepped upon prior sponsor’s approval – this would be ideal solution, otherwise any exceed of the limit will likely result in the contract amendment.