Best Practices for Documenting Compliance Training in Healthcare 

Compliance experts weigh in with ideas and advice to ensure you cover all angles in documenting healthcare compliance training at your organization. Keep reading to learn the underestimated value of paying attention to compliance training documentation.  

Why Compliance Training Documentation Matters 

There’s the old saying that if it’s not documented, it wasn’t done. This has been quoted ad nauseum over the last 20 years we’ve been in clinical research. Well, what about training? If you don’t document that, was it not done? We are going to argue yes…and no.  

There have been many times where we have talked to auditors or inspectors who wanted to know if training occurred. While the answer was yes, there also have been times where we didn’t have any concrete documentation to support it, save for the Outlook meeting invite with everyone’s name on it. Even more surprisingly, there have been times where that has been accepted. Now, call it chance, dumb luck, or we dodged a bullet, but this is not always the case.  

Being fully transparent here – we don’t advise winging it and hoping they don’t look. You will still need to document that training occurred, whether or not someone looks or not is irrelevant.  

But the day will come (the day always comes) when someone asks if you have that training record for that employee who improperly followed a policy, and you just shrug and say…you don’t. Then they start digging. Good luck avoiding findings now, champ.  

Should You Use Paper or Electronic Training Documentation? 

Now for the purposes of this article, we are taking the perspective of conducting training on an updated policy or procedure and not a complete educational program. The way we see it, you have two choices, paper or electronic.  

Using Paper for Training Documentation 

The simple paper attestation — It doesn’t get any easier than this. It doesn’t even take that much time to create a basic attestation template that captures the following: 

• Employee name 
• Training title and date 
• Training instructor 
• Training location and duration 
• High-level overview of the training itself 
• Signature line by employee and instructor to document that employee received the training.  

Notice we did not say to include that the employee understood the training. You can’t do that with a simple attestation. If you want to do that, create a quiz of some type and have the employee take it, and if they pass, attach it to the attestation.  

Of course, if the employee still messes up, okay, then they attested to the training and demonstrated competency, but somehow, they still didn’t understand? A regulator is going to delve deeper here, so always be cognizant of why you are including something with your documentation.  

Documentation for documentation’s sake is bad. Documentation clearly spelling out what was done is good. Let’s move on. 

Electronic Training Documentation 

Okay, we agree that leveraging a learning management system or dedicated software to automate record keeping or generating reports would be ideal, and we don’t disagree. But a lot of places don’t have that. So, what do you do? Zoom works wonders here.  

Schedule a training over Zoom and encourage everyone to sign into the Zoom chat. Put the agenda as part of the meeting, along with a concrete explanation of the training, with time to ask questions and complete an attestation in the chat. Let the chat serve as the attestation.  

What do you do with this? Record the meeting. Zoom will allow you to record meetings and archive them for future use. Download the meeting out of your Zoom cloud and store it on your network or in a safe place. Not only are you getting an attestation, but you are also creating a training library for your future reference. Thank us later.  

Documentation Best Practice Blends Both Approaches 

Now, which do you pick – paper or electronic? Whatever works for your organization. We personally don’t like paper. I would much prefer electronic documentation because I don’t like hundreds of training binders stored in the facility, on top of the fact that eventually you will run out of room and will either have to scan it in anyway or ship it off site.  

The best practice is to have a paper attestation signed and scanned onto the network into an education folder. Networks always back up, and this saves storage space. Unless HR wants to store all of this – then give it to them. They don’t store enough anyway. 

Prepare for On-Site Auditors — Invest in a Documentation Strategy 

Maintaining accurate, comprehensive training records is critical. By doing so, you can close potential gaps, and ensure you are well-prepared for auditors and inspectors who come on site to investigate complaints. It seems so simple, until you don’t do it and realize you don’t have it.  

Investing in record-keeping is an investment in your success.  

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John R. Nocero, Ph.D., and Andrea L. Bordonaro, MAT, blog on LinkedIn as “The Q-Kids,” discussing everything related to clinical research education, inspiration, and professional connection.