Why eCOA Oversight Matters for ICH E6(R3), EMA, and FDA Compliance

Steve Begley:

Regulators are closing the gap between what is intended to happen at the site level and what sites can actually demonstrate. The EMA, FDA, and ICH all emphasize the same principle: oversight must be traceable and attributable throughout the life of the trial.
For decades, oversight was documented through attestations or paper sign-offs that provided very little evidence of ongoing review. That’s no longer acceptable. Regulators now expect sponsors to show when investigators reviewed participant data, how they confirmed accuracy, and how they managed changes. It’s about creating a continuous chain of accountability that can be verified at any time.

Ultimately, this shift strengthens data integrity and ensures participant safety. Oversight is no longer assumed—it must be proven.

Aubrey Verna:

These updates make clear that oversight isn’t a single event but an ongoing process that needs to be documented electronically. The EMA’s guideline requires every action to be attributable to an individual, captured in a secure system, and preserved in an audit-ready state. Meanwhile, ICH E6(R3) reinforces that the Principal Investigator (PI) is responsible for supervising delegated staff and reviewing clinical data consistently on time.

Clinical trial sponsors can no longer rely on scanned signatures or static PDFs. The expectation is for a system-generated record showing when an investigator reviewed data, which version they saw, and whether they re-reviewed updates.

From an operational standpoint, digital documentation reduces confusion across teams. Sites can see their review tasks clearly, and sponsors gain a transparent view into site activity without chasing paperwork.

Steve Begley:

Manual oversight introduces several risks—compliance, data quality, and operational efficiency among them. When documentation is paper-based, it’s easy to lose track of when a review happened or whether new data was checked after initial sign-off. Scanned COA files may not reflect the true sequence of events, and handwritten notes are open to interpretation.

Auditors are trained to look for those inconsistencies. If an oversight record can’t demonstrate attribution or timing, it raises questions about data validity. Even when sites follow the process, without digital traceability, they can’t prove it.

Aubrey Verna:

The key is integration. eCOA Oversight shouldn’t sit outside the system where data is captured; it should happen within that same workflow. In modern eCOA platforms, investigators can review and acknowledge participant data electronically, receive automatic prompts to re-review if updates occur, and maintain a clear, time-stamped history of those actions.

That design eliminates the lag between data collection and oversight. It also supports a consistent process across sites, regardless of geography or study phase. For sponsors, this means an always-available, audit-ready record that reflects real operations, not a separate administrative task.

Steve Begley:

It means your documentation can stand on its own. Every action is attributable, every review is dated, and there’s no need to reconstruct the sequence of events when an auditor asks for evidence. Oversight logs should come directly from the system and reflect exactly what happened.

Audit readiness isn’t just about passing inspection—it’s about knowing your processes are sound. The ability to show complete, unaltered oversight records at any moment demonstrates a sponsor’s commitment to data integrity and participant protection. That’s the level of transparency regulators expect, and frankly, it’s what good science requires, particularly with eCOA.

Aubrey Verna:

We designed Advanced eCOA Oversight to address how much time and uncertainty sites were facing around documentation. Everyone saw the need for oversight, but the tools available made it cumbersome. Investigators were printing, signing, scanning, or managing separate systems to stay compliant.

Our goal is to deliver oversight directly into the eCOA platform so it becomes second nature. Investigators and delegated site staff can review data electronically, apply secure signatures, and receive automated re-review prompts when data changes. Sponsors can configure access levels, generate audit-ready reports, and demonstrate oversight with clear attribution.

We built it to align directly with EMA, FDA, and ICH E6(R3) expectations, but just as importantly, to make compliance easier for the people doing the work. The eCOA technology should support oversight, not add to the workload.