The monitoring visit is not when compliance happens. It is when somebody else checks whether compliance happened, and Justin Coffeen argues the gap between those two sentences is where most findings come from.
What this episode covers
- Why documenting concurrent with a visit is a different activity than documenting at the end of the day
- Informed consent as an ongoing process rather than a signature captured once
- How delayed adverse event reporting damages the dataset, not just the audit trail
- Why the Good Clinical Practice framework holds steady across orthopedics, oncology, and hepatology
The cost of writing it up later
Concurrent documentation sounds like a scheduling preference. It is closer to a data quality mechanism. A note written during a visit records what happened. A note written at six in the evening records what the coordinator remembers about what happened, filtered through four intervening participants.
Justin Coffeen came to clinical research from patient care, where the same rule applies for the same reason. What gets reconstructed later is smoother, more coherent, and less accurate than what gets captured in the room.
The detail that goes missing is rarely the obvious one. It is the offhand remark, the hesitation before an answer, the symptom the participant mentioned while putting a coat on. None of that survives a six-hour delay, and some of it is exactly what a safety review would want.
Consent is a conversation with a paper record
Sites that treat consent as an enrollment task tend to produce a signed form and very little evidence of what was actually discussed. When a protocol amendment lands, or a participant’s circumstances change, that thin record becomes a problem nobody can fix retrospectively.
Justin Coffeen’s position is that the signature documents a conversation and is not itself the consent. The regulatory file should let a reader reconstruct what the participant understood, and when, and what changed.
Transcript
So I want to talk about something that comes up constantly in clinical research, and honestly, I think it gets treated backwards more often than not. GCP compliance. Good Clinical Practice.
Here’s what I see a lot of: teams treating it like a thing you prepare for. Monitoring visit’s coming up, let’s make sure the binder’s current, let’s reconcile the CRFs, let’s make sure everyone remembers the protocol version we’re on. And look, I understand why that happens. Sites are busy. Coordinators are managing multiple protocols. There’s a lot of moving pieces.
But the monitoring visit isn’t when compliance happens. The monitoring visit is when someone else checks whether compliance happened. Those are really different things.
What I’ve come to understand, and this is shaped by both my clinical background and my time in the Air Force, is that GCP has to be a daily operating standard, not a periodic review. And when I say daily, I mean: you document concurrent with the visit. You don’t hold adverse event information until you have time to compile it. You don’t wait until the monitor asks about a discrepancy to address it.
Let me give you a concrete example. Informed consent. A lot of teams treat consent as a single event, the participant signs the form at enrollment, done. But consent is an ongoing process. If the protocol gets amended, you may need to re-consent. If the participant’s situation changes significantly, there may be a conversation to document. The form isn’t the consent. The conversation and the documentation of it, that’s the consent.
And here’s the thing about adverse event reporting that I think matters a lot: the accuracy of AE data isn’t just a regulatory obligation. It’s the safety signal that the trial is designed to capture. If you underreport or delay, you’re not just creating a finding risk, you’re actually corrupting the dataset that the whole study is built to produce.
I work across orthopedics, oncology, and hepatology. The disease areas are different. The patient populations are different. What doesn’t change is the GCP framework. It’s the constant. And when you genuinely internalize it instead of treating it as a checklist, you start seeing it as the structure that makes the research credible. Which is the whole point.
If you want to talk more about specific GCP compliance practices, documentation standards, or what audit-ready actually looks like in practice, I’ll get into that in future videos.