All case studies
eTMF QC - Inspection-Ready Completeness & Accuracy
Outcome-based QC with defect classes, checklist gates, and inspection-ready dashboards brought consistency across sites and vendors.
Context
- Global sponsor with multi-country Phase II/III studies; CRO mix varied by region.
- eTMF completeness and QC accuracy were inconsistent across sites/vendors.
- Inspection risk: missing essential documents and outdated versions.
Approach
- Outcome lane: per-artifact QC with completeness and accuracy SLAs.
- Defect taxonomy aligned to DIA reference model and SOP versions.
- Checklist gates per artifact type; version control & effective-date checks.
- Dual-review for high-risk artifacts (e.g., ICF, Safety, PV agreements).
- Dashboards: completeness %, accuracy %, age buckets, site/vendor heatmaps.
Operational Playbooks
- Artifact-specific QC checklists (ICF, IB, CV, Delegation Log, Safety Letters).
- Version/expiry checks with effective-dates; supersede/retire flow.
- Site activation packet sanity checks; late upload chase SOP.
- Discrepancy management with reason codes and recurrence watchlist.
Measured Results
- Completeness to 98%+ on critical sections pre-inspection.
- Accuracy AQL 99.5% on dual-review classes; overall QC 99.0%.
- Aged discrepancies (>14d) down 63% with chase SOP and owners.
- Inspection findings reduced; faster closeouts across sites.
Lessons Learned
- Defect classes + examples keep reviewer alignment high.
- Dual-review only where risk and cost justify; rotate pairs.
- Heatmaps focus coaching on sites/vendors with recurring gaps.
- Definitions embedded in dashboards prevent metric drift.
Ready for inspection-ready QC?
Well set outcome SLAs, QA, and dashboards aligned to your SOPs and DIA model.
