Learn Before You Leap

Training is a dirty word. In the corporate environment, trainers are relegated near the bottom of the pecking order. Training departments are considered the holding pen for under-performing line staff and has-been managers. Training programs are considered to be an onerous burden on an employee’s schedule. And not surprisingly, when it comes to budgeting for training, it is always last on the list and the first to be cut. When implementing change in the clinical research process, especially when introducing new concepts or technology applications, this attitude is fatal.

Maybe we need a new word for it. Training is boring. Training is passive, repetitious, artificial, divorced from reality. Of course none of these adjectives need be true about the learning process, but too often they are. So let’s call it “learning” for now, and talk about how essential learning is to process improvement.

Process Improvement as Learning

Process improvement itself is essentially a learning process: we learn by analyzing the root causes of delay, dysfunction or inefficiency; we learn by mapping how work actually gets done; we learn from the metrics we use to gauge where we have been and where we are getting to. The phrase “lessons learned” is an essential component of new technology introduction: if your company is piloting new software and you do not formally and proactively document your experiences, from your earliest attempts to use the software, you will simply repeat the mistakes and missteps of those who have gone before you. The more you use the software the more there is to learn, and the more that will be lost if someone isn’t keeping track. As obvious as this is, few companies have a formal process for capturing their experiences. There are well-established procedures for instituting such processes – indeed, you may have colleagues in another area of your company who have done so. It is time to bring this into clinical development.

Being a “learning organization”, or building a “knowledge management system”, are two of the most fashionable phrases in process improvement today. The logic of these concepts applies well to clinical operations, but you need not be intimidated by the textbooks on these subjects into thinking that these concepts are beyond the capability of clinical operations staff to exploit. Instead, let your efforts at learning be reinforced by these fashions.

Last on the List, Last to be Funded

As integral to process improvement, technology adoption, and knowledge management that learning is, the dilemma is that training is rarely budgeted for. No dollars, no learning – at least no formal, proactive and comprehensive learning. This universal lack of funding for training is one of corporate life’s most self-defeating characteristics.

The reasons are so obvious that it is hard to even write about. Which do you think is more efficient? To teach someone how to do a monitoring site visit according to company SOPs, or to let them do a few visits and then explain them to what they did wrong? To teach them the contingency plans for software user problems, or to wait until you realize you aren’t getting the benefits from the software you expected?

And yet, if you put a training line item in your regional monitoring program budget, or your EDC implementation budget, it will always be at the bottom of the spreadsheet and it will always be the first one to go when your boss, or your contracting officer, wants to prove how great at cost-cutting she can be.

Learning through Serendipity

How do we get by as well as we do if training budgets are always cut? We do it through the creativity, conscientiousness and goodwill of our staff. We as corporations learn through serendipity – through the initiative of individuals to mentor their juniors, share information with their peers, record their mistakes and their insights. Think of how much more productive we would all be if this valuable insight was captured and delivered in a conscious and professional process of learning.

What’s the problem with serendipitous learning? Today most process improvement projects, or technology adoption initiatives, are so complex, and line staff are so busy with their everyday work, that the learning required to make these innovations succeed cannot depend on happenstance. You cannot rely on your colleague in the next cubicle to tell you what he learned when he tried to use that CTMS for the first time; you cannot rely on your fellow monitor in the next state to tell you how to avoid getting your expense report kicked back by accounts payable. Literally millions are spent to get to the point where process innovation is designed, or new enabling software is rolled out. To not spend the money to go that last mile of learning is to make a mockery of those investments in innovation.

Training that Works

There are at least two key points about institutional learning which are of high relevance to clinical operations. First and foremost, once is never enough. For busy, expert professionals used to doing work one way (and doing it well), you cannot expect them to absorb the learning required to implement the new process correctly in one sitting. We always recommend a three-part program: an overview of the process or software, during which all one hopes for is that the field is plowed and ready for planting. Next you go over everything again, in more detail, and this time the students will be ready for the seeds to be planted. Finally, you train just-in-time, at the moment when they start using the process or software, and only then will the plant truly blossom.

Second, when it comes to technology adoption in particular, you cannot abdicate the learning process to the software vendor. What needs to be learned in a software implementation situation is one-fifth screen navigation and four-fifths business rules. Business rules are the hundreds of micro decisions that a company needs to make about how you, given your particular organizational chart, staff skills, strengths and weaknesses, monetary and time resources, and so on, will actually use the software. For instance, a CTMS may enable your staff to write a Site Visit Report within the application. How does this fit with your SOPs? What information contained in the SVR is supposed to be communicated to other departments? Can this communication be automated? Should it be? Do you want changes to SVRs to be recorded and auditable? Etc. The vendor cannot decide these things for you – only you can make these choices, and once made, they must be taught.

It’s the Will, not the Way

Some companies pat themselves on the back for “taking care of training” by spending money on an innovative learning technology; “eLearning” is another heavily promoted fashion. There is no question that there are now (and always have been) many techniques of training delivery that can enhance and make learning more efficient (none more powerful than a good teacher, something no technology can replace). But delivery is secondary to the content – indeed, to having content, to making sure that your company does not cut training out of the budget and that you have taken the time and expense to document lessons learned, make the business rule choices, and are ready to devote staff time to learn them.

It is said “those who can, do; those who can’t, teach”. When implementing clinical research improvements, those who don’t learn, won’t succeed; those who do, will. .