What Doesn’t Kill You Makes You Do More Paperwork

Clinical Researcher—January 2020 (Volume 34, Issue 1)


Christine Senn, PhD, CSM, CCRC, CPI, ACRP-CP, FACRP


Explorations into another person’s job are always eye-opening experiences. I have fostered my self-perception of being a generalist in clinical research by spending a year or more embedded in most departments found in clinical research sites—particularly regulatory, human resources, business development, marketing, pharmacy, and quality assurance departments at independent clinics and academic medical centers. Yet somehow, over those 15 years, I never pursued the same deep dive into accounting.

Wow. What a trip.

I knew that sites are treated like commodities, where most investigators (novices and experienced alike) are offered the same budget, despite the quality of work or timeliness of enrollment they had proven. What I didn’t know was that research sites have to fight tooth and nail to get paid for some items that are in the fully executed budgets. Do you find it shocking that a contract can be fully executed by both parties and yet be disregarded?

Who Thought These Were Good Ideas?

Let’s go through some of my discoveries:

  • Investigational New Drug safety reports are generally negotiated such that we are to be paid a flat fee, incrementally—for example, $25 per 10 safety reports issued to the investigator. For some reason, in my site network we are fought continuously on these, and often don’t get paid at all for them. Despite the fact that our client (the sponsor or clinical research organization [CRO]) submits these reports to us, they require that we provide their accounting people with proof of the reports. Unless the sponsor/CRO has a portal that contains the reports, this has proven to cost more in time spent creating lists than it is worth for the money we might receive.
  • The same is true of protocol amendments, where we can only receive payment if we list the date and version of the amendment…which was sent to us by the institutional review board and is thus part of the sponsor’s/CRO’s records already.
  • Dry ice for shipping lab specimens is likewise a negotiated line item in a budget, and the likelihood of being refunded for this is even worse. Oddly, although our client has record of the frozen shipments they have received from us, requests for payment are routinely denied. We are very frequently asked for detailed dry ice purchases, which is excessively burdensome.
  • A little better are procedures. Sites are asked for proof of the procedures (such as endoscopies), despite the data about the procedures having already been entered into the sponsor’s/CRO’s electronic data capture (EDC) system. Again, this is added work on the site for information the sponsor/CRO already has.
  • Most ridiculous of all is the invoicing system itself (see below).

Real-World Frustrations in Invoicing

If we frame our minds around client/vendor relations, then a clinical research site is a vendor of the sponsor or CRO. With that in mind, I accept that it is reasonable that a site would have to invoice for certain work performed. That said, nearly every client we have rejects invoices if there is any sort of error (such as using the investigator’s first name of Alex instead of Alexander), or even if we invoice for too many budget items at a time. There is also the curious case that some of our clients require us to use a purchase order number that they have to provide us, and we cannot submit an invoice until we ask them for the number we should use.

If you work for a sponsor or CRO, please take your mind away from work and into your home life for a moment. Now ask yourself: Do you get to disregard a bill from your utilities company because they spelled your name wrong? My water bill comes to Kristine Senn; I still pay it. Could you tell the phone company you won’t pay them unless they send you separate invoices for each instance? That would be like me arguing to Verizon that I won’t pay them unless they send me separate bills for each of the phones I have on the account. Would any of these companies wait for you to give them an invoice number, and accept that they wouldn’t get paid until you took the time to respond to them? That’s frankly ludicrous.

Spinning Wheels Go Round and Round

I’m sad to say these are not all of the examples I discovered, but these are the ones evident in 87% of the trials we conducted in 2018–19. (The rate would be worse/higher if we tracked the issues involving invoices rejected for trivial reasons, but we did not track those.)

In general, it takes approximately three months of us re-invoicing, obtaining proof, following up, obtaining additional proof, and re-invoicing in order to get approval for payment—and that’s if we don’t decide to just write off the cost due to the extent of the proof required. (Don’t get me started on payment timelines. Small sites don’t have the cash flow, credit, or vendor relationships to support the lengthy delays between invoicing and payment.)

It’s curious that sites, which typically have the fewest resources of all of the companies in the human trials pipeline, should have to do the extra work of proving so much of the work performed. On top of that are the delays in paying. For every sponsor or CRO director who thinks their payment timelines meet their company’s policies, I want to break it to you that your definitions of the timelines are flawed.

My guess is that your company’s measurable is “time from approved invoice” to “date check sent.” I would argue that you would see that site payments are delayed by an additional 90 to 180 days if the timeline started ticking at “invoice received from site” because of the silliness described in the scenario above that results in lengthy invoice approval times.

No Wonder “One and Done” is a Problem

These issues dovetail precisely into the reasons investigators leave research; they lose money doing it and/or the burden is too high.

In my experience, investigators are willing to do what is necessary to ensure patient safety and document data, but the regulatory and financial expectations are definitively onerous. When many providers need to see four non-research patients each hour just to stay profitable, what is the message from the industry when they are expected to spend multiple hours proving that they should be paid?

On the positive side, I learned during my foray into our accounting department that startup and closeout fees are always paid without difficulty. Patient data that end up in EDC systems are likewise usually paid without difficulty. This implies that good systems are in place for those portions of the accounting processes, and it would not be difficult for sponsors and CROs to add processes for the remaining budget items as a means of improving customer service.

Sites might be “vendors” to sponsors, but they are important and necessary vendors, and keeping more sites in business is key to the entire clinical research process.

Christine Senn, PhD, CSM, CCRC, CPI, ACRP-CP, FACRP, (csenn@iacthealth.com) is the Chief Implementation and Operations Officer at IACT Health.