Items Research Clinics Usually Overlook When Negotiating Clinical Trial Budgets
Clinical sites often forget to negotiate several common expenses on their budgets. Here are some fees that often get overlooked. These fees should be non-refundable and billed upfront or as pass through costs to the sponsor of the research study via an invoice from the site as soon as the cost is incurred.
1) Protocol Amendment fee. During a clinical trial, there are numerous protocol changes. If you have more data at your site from previous studies, you can track how many times there have been protocol changes. For example if you did 20 studies, count the amendments, divide by 20 and this will give you an average. This will give you an idea on how much to ask for a protocol amendment fee in your budget. Based on past experiences, the average fee is $2,500. Regardless of the amount, it’s important to add a protocol amendment fee into your start up budget.
2) Archiving Fee. Sometimes study records need to be kept for five, ten, twenty or thirty years depending on your sponsors and the nature of your trials. Storing research data requires security, labor and space that incur hidden expenses that research clinics often neglect to add into the initial budget. There is a movement to move all the files up to the cloud in virtual workspaces like Intralinks VIA, but in the mean time it is important to bill this fee upfront.
3) Dry ice fee. Every research clinic needs dry ice regardless of whether you have dry ice already on site or whether you have to go and purchase it from grocery store.
4) Transportation fee. Transporting patients to and from clinic sites also cost money and should be billable to the sponsor. Transportation fees include using Uber or a taxi to drive patients to and from the research clinic. Some clinics have dedicated drivers to transport patients and the costs can add up. It’s important to keep all receipts and invoices and send them directly to the sponsor monthly or quarterly depending on how busy or slow your clinic is.
5) Start Up fees. Start Up Fees include protocol training, study coordinators training, PI training, investigator meeting time, protocol review for the investigators, EDC training, EDC access for the coordinators and all other vendors etc.
The sponsors of the clinical trial may refuse to approve these fees. However, if you keep insisting and provide written policies that justify the necessity of these fees, the sponsor will likely to approve these on the budget.
