For decades, clinical trial quality was synonymous with retrospective checking—Source Data Verification (SDV) and onsite monitoring visits. ICH E6(R3) effectively ends this era, mandating a proactive, system-based approach.
1. Data Governance is No Longer Optional
Section 3.16 of the draft guidance explicitly states that sponsors must implement a system to assure data quality throughout the data lifecycle. This means "Data Lineage" is now a compliance requirement.
STRATEGIC IMPLICATION
Sponsors can no longer rely on CROs to "handle the data." You must have visibility into the data flow from eSource to Safety Database. This is where our System Integration Analysis service becomes critical.
2. Risk Proportionality
R3 emphasizes that quality assurance activities should be proportionate to the risks inherent in the trial. This validates the RBQM approach: focus your resources where they matter most.
- Critical to Quality Factors (CtQ): Identify what actually impacts patient safety and trial reliability.
- Quality Tolerance Limits (QTLs): Define the numeric thresholds that trigger a systemic investigation.
3. The Rise of "Fit-for-Purpose" Technology
The guidance acknowledges the use of computerized systems and digital health technologies (DHTs). However, it requires that these systems be "fit for purpose."
This is why generic, out-of-the-box dashboards often fail regulatory scrutiny. Custom R-Shiny applications that are validated for specific study protocols offer a higher degree of compliance than rigid, one-size-fits-all vendor platforms.
Conclusion
ICH E6(R3) is an opportunity to modernize your clinical operations. By moving from reactive QC to proactive QbD, you not only ensure compliance but also significantly reduce operational costs.