Quality Isn't Someone Else's Job

Quality isn't for passing an inspection. It's for the integrity of the study and for the protection of participants.

The concern I hear most often when the conversation turns to ICH E6(R3) and a culture of quality isn't philosophical. It's practical. And it 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) isn't asking you to do more. It's asking you to think differently about what you're already doing— or should be doing.

ICH E6(R3) didn't invent new principles. Quality by Design, Critical to Quality Factors, fit for purpose — these ideas were always embedded in ICH E8(R1) and within GCP principles. What ICH E6 did was explicitly name them within the R3 iteration. When the FDA, along with international regulatory partners, emphasizes a culture of quality, they aren't announcing a new certification requirement or a checklist to complete. They're asking everyone involved in a clinical trial to lift their eyes from the task in front of them and see the whole picture.

That's a mindset shift. Not a compliance event.

ICH E6(R3) didn't change the rules — it named the mindset.

So what does quality actually look like?

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

Ask yourself whether you know what's critical to quality in your current trial. Not in general but in this study, with this population, this protocol, and these endpoints. Critical-to-quality factors are the elements whose integrity is fundamental to participant safety, reliable results, and sound decisions based on those results. If you can name them, you're already thinking beyond your checklist.

Ask yourself how your role touches those factors. A coordinator who understands that timely adverse event reporting is a critical-to-quality factor in their trial thinks about that task differently than one who sees it as a box to check. The task is the same. The awareness behind it changes everything.

A data coordinator who understands that primary endpoint data is a critical-to-quality factor treats a missing value differently than one who works through a query queue in order of arrival. Not every query carries the same weight.

Asking what happens next — and what happens if. These are among the most powerful tools available to anyone on a trial team, regardless of title. They surface assumptions, catch gaps, and keep quality thinking active rather than reactive.

When those three questions become habit, something else tends to follow naturally—transparency.

Transparency of information and processes helps teams develop a much more collaborative network of workflows and ownership. For example, a study dashboard showing high-risk areas for the trial, open issues, and who owns each one. If this is something you already have for your team, then that’s a great workflow tool. My question is this: who controls this information, and who sees it?

If the dashboard is a private tool reserved for upper leadership, then how can we promote awareness and transparency for all? Keep in mind, transparency doesn’t mean literally every piece of information is shared across all roles. It means that we find a way to promote shared awareness, making sure everyone on the team can see how their piece connects to what matters most in the study. An internal team dashboard may look slightly different from the sponsor-facing dashboard, but both dashboards give an accurate representation of the true health and progress of the study.

A team that can see the whole picture builds quality into every corner of it.

Now for the harder question.

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

Here's what I've come to believe. A culture of quality isn't really about the task. It's about how you feel about the task — and the person on the other side of it.

Consider informed consent. Two coordinators can walk through the same legally effective consent process, cover every required element, answer every question, and get a valid signature. Both did the job correctly. But one of them notices the participant hesitate when decentralized blood collection comes up. They pause. They ask about comfort with finger pricks. They offer the recommendation of writing reminders on sticky notes or setting phone alerts for the at-home collection days. Nothing about that exchange was required of the coordinator, but all of it was in service of the trial — because a participant who feels supported and prepared is more likely to complete the study accurately and safely.

That's not a delegated responsibility. That's a quality mindset applied to a human moment.

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

When you accept a delegated responsibility, you become part of the quality chain.

But the chain is only as strong as the thinking and care behind each link. You don't need authority over the whole trial to make your link a strong one. You need to understand how your role touches what's critical in this trial, and you need to be willing to ask one more question when something doesn't sit right.

Ask questions, such as “What happens next?” and “What happens if this goes wrong?” are important. Those aren't disruptive questions. They're the questions that catch problems before they become findings.

Flag 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. A concern swallowed because it felt too small, or because the moment passed, has a way of becoming a finding later. You don't need certainty to speak up. You need enough awareness to notice something feels off.

Treat the people in your trial as the reason the work exists. Not as enrollment numbers. Not as data sources. As people who said yes to something that asked a lot of them — their time, their bodies, their trust. When that's your orientation, quality stops being a standard you meet and starts being something you're genuinely motivated to protect. The regulations exist because of them. The Critical to Quality Factors exist because of them. The whole framework — every principle, every oversight expectation, every SOP — points back to a person who showed up and trusted the process.

I won't pretend there's a magic answer for when the culture around you isn't there yet. What I keep coming back to is this: stay in the conversation. Reframe the question when it doesn't land. Quality culture doesn't always build from the top down. Sometimes it starts with the people who refuse to stop caring about it.

Where to start

Read ICH E6(R3) Section II for the core GCP principles that establish quality as a foundational expectation across the entire trial. And if you feel like continuing your journey, take a look at ICH E8(R1) to understand more about how quality gets designed into the study. Then look at your current trial and ask: do I know what's critical to quality here? Do I know how my role touches it?

If the answer is no — that's exactly the place to start.

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