These are the words I often share with clients when talking about compliance problems. What I mean by, “It’s never a problem, until it’s a problem,” is that:
- It is difficult to foresee everything when it comes to compliance
- Most problems will not rear their ugly head until late in the game
- Don’t try to skate by without doing what you know is the right thing to do in the first place
- An ounce of prevention is worth a pound of cure
- 99.9% of people surveyed may not think it is a problem, but it only takes one auditor to trump them.
I could go on, but you get the idea. All too often have I seen people take compliance for granted only to have an audit burn them in the end. What is most troubling to me is when I can see the train coming down the tracks and am yelling “Train!” at the top of my lungs, yet for some unknown reason, these calls go unheeded until it is too late.
Commitment to Compliance Problems
Sometimes the reason we ignore compliance problems are based on pure ignorance or simple frugality. Other times I have seen just pure arrogance. Perhaps there is a disconnect between the executive-level commitment to quality and the departmental-level implementation of it?
All too often though I see the reverse is true where there is no executive commitment. Perhaps the organization takes a risk-based approach to compliance. One that says, we will be compliant enough, or we will work to be compliant in the areas where there is the greatest risk, such as Clinical Operations.
How do you know what level of commitment there is to compliance throughout your organization? How deep within the organization does that commitment extend? What can be done to educate colleagues on the dangers of sitting on the compliance edge?
Yes, draft guidance is subject to change before it is final; however to blatantly disregard the entire document is just plain foolishness.
Recently I recalled a conversation about draft guidance and hearing, “Well, after all, it is just draft guidance after all. It’s not final.” Really? That is the approach to compliance? Taking that same line of reason, one could say for the guidance that does exist, “Well, they are just guidance documents; they are not regulations so therefore we need not be concerned.”
Guidance, whether it be draft or not, represents the agency’s current thinking on a given topic. Yes, draft guidance is subject to change before it is final; however to blatantly disregard the entire document is just plain foolishness. Sure, sections may change or a particular item might be removed, but there are ways to gain insight into the specifics of what might be edited prior to becoming final. Wanton disregard is not one of them.
Structured Approach to Compliance
Whether it is foolish disregard or organizational-ignorance, a structured approach to compliance can go a long way toward averting a disaster at audit time. Rather than looking at specifics in regulations, guidance, and draft guidance, look for trends. Begin to ask: why were these elements added? How will they affect us if they do apply? What was the rationale behind the regulation? What processes and procedures should we look to modify now if we know agency change is coming? In so doing, you will not only be better prepared for an audit, you will begin to change the organizational mindset as well.
Finally, it never hurts to include an expert or two along the way. Especially early on in the process or at the beginning of a study. Sometimes experts with different domains of experience are warranted. Whether it is for information technology, GCP, or even training records, each expert can add value and help to avoid a crisis, especially in larger and more complex studies. The idea is to identify the problem before it is a problem. Where compliance is concerned, ignorance is most certainly not bliss.