Quality Isn't Someone Else's Job

Quality isn't about passing an inspection. It's about the integrity of the study and the protection of the people who agreed to be part of it.

When the conversation turns to ICH E6(R3) and building a culture of quality, the concern I hear most often isn't philosophical. It's practical, and it usually sounds something like this:

"We already have SOPs. We have a quality department. I took my GCP training. What else am I supposed to do?"

It's a fair question, and the honest answer is that ICH E6(R3) — the third revision of the International Council for Harmonisation's Good Clinical Practice (GCP) guideline — isn't asking you to do more. It's asking you to think a little differently about what you're already doing, or what you should be doing.

The R3 revision didn't invent new principles. Quality by design, critical-to-quality factors, fit for purpose — those ideas were already living inside ICH E8(R1) and the GCP principles long before R3 named them out loud. So when the Food and Drug Administration (FDA) and its international regulatory partners emphasize a culture of quality, they aren't announcing a new certification or handing you another checklist. They're asking everyone on a clinical trial to look up from the task in front of them and take in the whole study, which is a shift in how you think rather than a compliance event you complete once and move on from.

So what does quality actually look like?

It starts small. Here are a few ways to begin thinking more broadly about the trial you're part of.

Start by asking whether you actually know what's critical to quality in your trial. Not in general, but in this study with this population, this protocol, these endpoints. Critical-to-quality factors are the elements whose integrity is fundamental to participant safety, to reliable results, and to the decisions that get made from those results. If you can name them in your own trial, you're already thinking past your checklist.

Then ask how your role touches those factors. A coordinator who understands that timely adverse event reporting is critical to quality in their trial treats that task differently than someone who sees it as a box to check. The task is the same; what's different is the awareness behind it. The same is true for a data coordinator who knows that primary endpoint data is critical to quality. They treat a missing value differently than someone working a query queue strictly in the order things arrived, because they understand that not every query carries the same weight.

The task is identical. The awareness behind it is everything.

Two more questions belong in that same habit: what happens next, and what happens if. They sound simple, but they're some of the most useful tools anyone on a trial team has, no matter their title. They surface assumptions, catch gaps, and keep your quality thinking active instead of reactive, and when those questions become second nature, something else tends to follow close behind...transparency.

Transparency of information and process is what lets a team build a genuinely collaborative web of workflows and ownership. Think of a study dashboard that shows the high-risk areas of the trial, the open issues, and who owns each one. If your team already has something like that, you've got a great tool on your hands. My question is just this: who controls that information, and who actually gets to see it?

If that dashboard lives only with upper leadership, it's hard to build real awareness and transparency for everyone else. Transparency doesn't mean every single piece of information is shared across every role. It means we find a way to create shared awareness, so each person can see how their piece connects to what matters most in the study. An internal team dashboard might look a little different from the sponsor-facing one, and that's fine, as long as both give an honest picture of the real health and progress of the study. A team that can see the whole picture is a team that builds quality into every corner of it.

Now for the harder question

Once you accept that quality thinking is part of your job, a harder question usually shows up close behind it: what do you do when you see the gap and you're not the one with the authority to close it?

Here's where I've landed. A culture of quality isn't really about the task itself. It's about how you feel about the task, and about the person on the other side of it.

Take informed consent. Two coordinators can walk through the same legally effective consent process, cover every required element, answer every question, and collect a valid signature. Both did the job correctly. But one of them notices the participant hesitate when decentralized blood collection comes up, so they pause. They ask how the participant feels about finger pricks, and offer a small suggestions like writing reminders on sticky notes, or setting phone alarms for the at-home collection days. None of that was required of the coordinator, and all of it was in service of the trial, because a participant who feels supported and prepared is far more likely to finish the study safely and accurately. That isn't a delegated responsibility. That's a quality mindset brought into a very human moment.

ICH E6(R3) and ICH E8(R1) can tell you what you're accountable for, and they can name the principles and lay out the framework. What they can't do is hand you the instinct that makes you pause, notice, and ask one more question. That instinct comes from genuinely understanding why the work matters, and then choosing to carry that understanding into every interaction.

When you accept a delegated responsibility, you become part of the quality chain, and that chain is only ever as strong as the thinking and care behind each link. You need to understand how your role touches what's critical in this study, and you need to be willing to ask one more question when something doesn't sit right.

You don't need authority over the whole trial to make your link a strong one.

Those questions — "What happens next?" and "What happens if this goes wrong?" — aren't disruptive. They're the questions that catch problems while they're still problems, before they ever become findings.

The same goes for flagging concerns, even when you're not sure they rise to the level of a formal issue. A concern raised early is a problem that can still be solved, while a concern swallowed because it felt too small, or because the moment slipped by, has a way of resurfacing later as a finding. You don't need to be certain to speak up. You only need enough awareness to notice that something feels off.

And through all of it, treat the people in your trial as the reason the work exists in the first place, not as enrollment numbers or data sources, but as people who said yes to something that asked a lot of them like their time, their bodies, and their trust. When that's your starting point, quality stops being a standard you have to meet and becomes something you actually want to protect. The regulations and critical-to-quality factors exist because of them. Every principle, every oversight expectation, and every standard operating procedure points back to a person who showed up and trusted the process.

I won't pretend there's a magic answer for the times when the culture around you isn't there yet. What I keep coming back to is this: stay in the conversation, and reframe the question when it doesn't land the first time.

Where to start

Read ICH E6(R3), Section II, for the core GCP principles that establish quality as a foundational expectation across the whole trial. If you want to keep going, take a look at ICH E8(R1) to see how quality gets designed into a study from the start. Then turn to your own current trial and ask: do I know what's critical to quality here, and do I know how my role touches it?

If the answer is no, that's exactly where to start.

Quality culture doesn't always start at the top. Sometimes it starts with you.

ICH E6(R3) Guideline for Good Clinical Practice and ICH E8(R1) General Considerations for Clinical Studies are available at www.ich.org.