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ICH E6(R3) expects oversight proportionate to risk, with the decisions documented. Use risk scores on each study to scope reviews, then track findings to closure inside eTMF Connect. Every step lands in the study record. Study Oversight and Risk Management is an add-on to eTMF Connect.

Your oversight record, built as the work happens. Use risk scores on each study to scope reviews, then track every finding and query to closure inside eTMF Connect. No separate tracker. No compilation at cycle end. Study Oversight and Risk Management is an add-on to eTMF Connect.

Still deciding how to bring risk-based oversight into your TMF process? Study Oversight and Risk Management in eTMF Connect give your team one workflow to score risk, run reviews, and document every decision, aligned with ICH E6(R3). Request a demo to see a review from risk score to record.

ICH recently finished the rewrite of Good Clinical Practice. Regulators are still rolling it out region by region, but the guideline itself is done. Annex 2 of E6(R3) landed on June 3. Combined with the Principles and Annex 1 from January 2025, the full GCP revision is now in place. This is not a minor update. It is the first rewrite of GCP since 2016, and it changes what regulators expect from sponsors and CROs when they walk into an inspection. Inspection readiness is shifting from document completeness to evidence continuity. Regulators do not evaluate files. They evaluate evidence. You can fill every placeholder in your TMF and still fail to show why a record exists, what risk drove the decision to collect or review it, and how that decision connected to the outcome of the study. E6(R3) names this shift directly. It asks sponsors and CROs to run oversight that is risk-proportionate, continuous, and documented, not a one-time QC pass at study close. Here is where most programs still fall short: - Oversight decisions get made, but the reasoning behind them lives in an inbox or a memory, not the record. - Risk gets discussed in a meeting, then disappears the moment the meeting ends. - Inspectors ask "show me why," and teams can only show "here is what we filed." That gap is why we built Risk Management and Study Oversight, available as an add-on to eTMF Connect. The idea is simple: surface where risk sits on a study, and turn that signal into an oversight activity with its own record, its own rationale, and its own outcome. Not a checklist. Not a one-time setup. A documented line from risk signal to oversight decision to what happened next. That line is what an inspector wants to see. Not a perfect TMF. Evidence that you knew where the risk was and acted on it, on the record. E6(R3) is not asking the industry to file more. It is asking the industry to prove the reasoning behind what gets filed. Building oversight software that makes that reasoning visible is where we are putting our engineering time now. See how risk-proportionate oversight gets documented in eTMF Connect: https://hubs.ly/Q04y2d0G0

Scoping a review today means guessing what to sample, or reviewing everything. Risk Management in eTMF Connect scores each TMF document by process zone, document type, country, site, and document owner. You review where risk sits highest, and you can show why. Request a demo to see risk-based scoping in action.

Compliant trial conduct is on you, and today the evidence of oversight sits outside your system of record. Study Oversight and Risk Management change this. Every review, finding, and scoping decision gets documented inside eTMF Connect, your TMF system of record.