Late stage CRF design and last minute RBQM roll-out can affect patient safety oversight and data quality. In this poster presentation we showed how up-front, joint CRF planning, along with early QbD collaboration across the protocol, CRF and RBQM teams can avoid data gaps and reduce site and patient burden, ensuring ICH E6(R3) compliance.

Why this Matters

• Missing critical data elements: Without early mapping, Key Risk Indicators (KRIs) and Acceptable Ranges (ARs) can’t be generated on time, directly impacting patient safety oversight
• Delayed lab & biomarker data: When lab/ECG/biomarker fields are unavailable until late, proactive interventions are impossible, raising the risk of protocol deviation.
• Inconsistent data standards: Varying S/AE or dropout definitions across studies block cross-trial analytics and trend analysis.
• CRF changes mid-study: Frequent format updates can affect KRI and AR calculations and cause false positive or false negative issues, wasting resources.

ICH E6(R3) and E8(R1) emphasize Quality-by-Design (QbD) across protocol, CRF and RBQM teams. Yet, real-world trials still struggle with late CRF build and delayed RBQM implementation, leaving sponsors blind to emerging risks.

The poster below, presented by Johann Proeve, PhD, Chief Scientific Officer at Cyntegrity, describes this issue in more detail.