Learn Before You Leap

Trainers are relegated near the bottom of the pecking order in the corporate environment. Training is a dirty word. Training departments are looked upon as the holding pen for under-performing line staff and has-been managers. Training programs are considered to be an onerous burden on an employees schedule. And not surprisingly, training is always last on the budget list and 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 teaching people how to use new processes. We are bored by the idea of training. Training can be passive, repetitious, artificial, and divorced from reality. None of these adjectives need be true about the learning process, of course, but too often they are. So lets use the word learning for now, and talk about how essential learning is to process improvement.

Process improvement as learning
Process improvement is 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 pilots new software without formally and proactively documenting your experiences, you willfrom your earliest attempts to use the softwaresimply repeat the mistakes and missteps of those who have gone before you. The more you use the software the more you learn, and the more you will lose if someone doesnt keep track. Even so, few companies have a formal process for capturing their experiences. Well-established procedures for instituting such processes existindeed, you may have colleagues in another area of your company who have already drawn up a set of procedures that you, too, can use.

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 do not let the textbooks on these subjects intimidate you. Do not think 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 as learning is to process improvement, technology adoption, and knowledge management, training is rarely budgeted for. No dollars, no learningat least no formal, proactive, and comprehensive learning. This universal lack of funding for training is one of corporate lifes most self-defeating characteristics.

The reasons are obvious. Which 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 to them what they did wrong? To teach them the contingency plans for software user problems, or to wait until you realize you arent 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 almost always be at the bottom of the spreadsheet and the first to go when your boss, or your contracting officer, wants to prove how great at cost-cutting he or 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, the conscien-tiousness, and the goodwill of our staff. We, as corporations, learn through serendipitythrough the initiative of individuals to mentor their juniors, share information with their peers, and 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.

Whats the problem with serendipitous learning? Today most process improvement projects, or technology adoption initiatives, are so complex and line staff so busy with their everyday work that the learning required to make these innovations succeed must not 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 clinical trial management system (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. Companies invest millions of dollars to design process innovation or roll out new enabling software. To not spend the money to go that last mile of learning makes a mockery of those investments.

Training that works
At least two key points about institutional learning are highly relevant to clinical operations.

Once is never enough. 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. The trainer provides an overview of the process or software, during which he or she hopes to plow the field and ready it for planting. Next, the trainer goes over everything again, this time in more detail, planting the seeds. Finally comes the real training, just in time, where the seeds sprout, take root, and grow. At the moment when the students start using the process or software, the plant can begin to blossom.

Dont abdicate to the software vendor. 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 comprise the hundreds of micro decisions that a company needs to make about how yougiven your particular organizational chart, staff skills, strengths and weaknesses, monetary and time resources, and so onwill actually use the software. For instance, a CTMS may enable your staff to write a site visit report (SVR) within the application. How does this fit with your SOPs? What information contained in the SVR should be communicated to other departments? Can this communication be automated? Should it be? Do you want changes to SVRs to be recorded and auditable? The vendor cannot decide these things for youonly you can make these choices, and once made, they must be taught.

Its 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, for example, is another heavily promoted fashion. Many techniques of training delivery 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 contentsecondary to having content, to making sure that your company does not cut training out of the budget, to taking the time and expense to document lessons learned, to making the choices among business rules, and to devoting the staff time to learn them.

Weve all heard the aphorism, Those who can, do; those who cant, teach. I offer a new aphorism for clinical research improvements. Those who dont learn wont succeed; those who do, will.