The financial success of any research site can be largely impacted by the contract and budget negotiation process. Knowing what to look for, what not to overlook, and what to ask during the negotiation stage has proven to be just as important as patient recruitment.
Limit of Liability/Insurance Clause & Governing Law
It is important to reach out to your site manager or CFO to address your site’s general liability and professional liability coverage limits. As far as the limits go, they should be outlined correctly within the agreement based on the certificate of insurance you have, in the event the Sponsor or CRO requests a copy for verification/validation purposes. How much is enough? When discussing limits of liability, this should be discussed with your insurance carrier or policy provider. Applications should be completed annually to ensure the appropriate limits cover your site.
As for governing law, the language should state that the location of governing law be based on where the study is being conducted. For example, if you are a site located in Oregon and the Sponsor is based in New York, you want to be sure that the laws governing the trial conduct are based on the State of Oregon. If the Sponsor does not agree to your request, either agree to remain silent or intentionally omit this section. In the event a location must be defined, you can choose one of the following neutral states: Delaware or New York.
Equipment – Who’s Responsible?
With most clinical trials, sponsors will lend equipment to sites (i.e. e-diary tablet, ECG machine, infusion pump, etc.). Who is the responsible party when it comes to covering shipping fees related to the return or devices and/or damaged products?
During the duration of the clinical trial, it is the site’s responsibility to oversee the use and calibration of the loaned equipment. At the end of the trial, when it is time to return the loaned equipment back to the sponsor, who should be responsible to pay the return fees? This is important to know and something you should consider when reviewing the CTA prior to signing off on accepting the terms of the agreement. Check the language to ensure that the return of the equipment is at the reasonable expense of the Sponsor/CRO. You, as a site, should not be spending money to send back the devices that you were asked to use for their trial.
What if the equipment has been damaged? Again, when negotiating the terms of the agreement, you should plan for every possible scenario and make sure to outline this within your comments to the Sponsor to ensure language covers your site from any commercial shipment mishandling or patient loaned equipment being lost or returned in non-working conditions. Once equipment has been returned it is then your responsibility, as a site, to make sure that it is in good working order and then returned to the Sponsor based on the terms of the agreement.
Prior to the beginning of a trial, be sure to request a comprehensive list equipment being loaned by the Sponsor or a contracted third party vendor along with the monetary values of the associated products, this will be beneficial in the event something happens to a piece of equipment and the Sponsor asks for more money than the value of the loaned equipment clearly outlined on documentation or within the agreement.
Publicity & Use of Sponsor Name
It is common practice that sponsors do not want their name associated with a site promoting trial opportunities when recruiting patients. The reason is to avoid favorability and to keep it anonymous to the public, to reduce coercive behavior. In the event that you wish to use the sponsors name, written permission is required and will more than likely require a detailed explanation for the need to use their name and/or logo when promoting a trial at your site (or if wanting to show a comprehensive list of study Sponsors you have done work with in the past).
The section of the contract that talks about publicity could mention sharing information about the trial to the general public. You will want to confirm with the sponsor whether or not they plan on posting the trial on ‘clinicaltrials.gov’. If they do intend to share the details on ‘clinicaltrials.gov,’ please make sure this is clearly outlined within this section of the agreement. Otherwise, if they don’t want public knowledge of the trial, you would want to make sure that it is not posted to ‘clinicaltrials.gov’ or any other public use websites.
Why would sponsors hold money? They really shouldn’t given the archaic nature of previously collecting data with carbon copy source documents and faxing records to a Sponsor or CRO (an activity no longer in practice these days) and with the known uses of modern technology which are intended to streamline and speed up clinical trial activities and patient reported outcomes and responsiveness to treatment.
As a site, you expect the money to be issued to you in accordance with the budget and based on work performed. You want to do everything you can to reduce holdback. If sponsors offer 10%, try to negotiate down to 5%. Maybe ask for the withholding to be capped at around $5k, or a value that seems reasonable based on the total cost per completed patient. Do your best to try and have zero withholding applied to payments with your rationale being – “we are in the midst of a pandemic. As a small business, we did not qualify for a PPP loan. There’s no reason to be withholding money from us if we are reporting data in a timely manner and resolving queries in accordance with the terms of our agreement..” Do what you can, take what’s rightfully yours, and don’t let them hold onto your money for too long.
Sponsors and CROs have gotten better at defining invoice terms, but what we’re still seeing is that they’re actually omitting some of these requirements. This is because many of the CROs and accounts payable teams are taking longer to verify invoices due to the amount of conditional items that are built into study budgets, that you, as a site, have taken the time to negotiate. Unfortunately it is now becoming common practice that you end up waiting longer to get paid for those conditional items (i.e. ultrasound, PET Scan, CT/MRI, etc.). Not only are you paying for those procedures directly to the vendor within two weeks of their occurrence, but you are now waiting 60 or 90 days for the sponsor to reimburse you. That is an awfully long time to wait. Define the terms for invoice reimbursements within the agreement that you need these paid within 30 days from the time of submission. If the Sponsor/CRO pushes back, let them know that you would be willing to agree to 45 days to give the AP department ample time to reconcile/verify the charges.
The information above only scrapes at the surface of items to think about when negotiating contracts. Learn more about negotiating tactics, contract language edits, and much more by tuning in to our on-demand two-part webinar Contract and Budget Negotiations: Crucial Steps for Site Success