GCP and data-integrity review, built for quality assurance.
Pressure-test documents for ICH E6 compliance, consistent deviation classification, and the data-integrity gaps that surface in an inspection — calibrated to a QA reviewer's standards.
The deviation log records 11 important deviations; the CSR §10.2 summary describes 8. An unreconciled discrepancy is a classic inspection finding.
MAJORGCP
No pre-defined important-vs-minor classification criteria
Deviations appear classified case-by-case. ICH E6 expects consistent, pre-specified criteria so the log is defensible.
MAJORBias risk
Important deviations concentrated at one site
Six of the eleven important deviations are at a single site, a possible source of bias that should be addressed in the analysis and CAPA.
MINORIntegrity
Missing-data handling not documented for withdrawals
Early-withdrawal data handling isn't documented, leaving an audit-trail gap between the SAP and the analysis.
The review work that eats your week
Protocol deviations classified inconsistently or without pre-defined criteria
Data-integrity gaps (missing-data patterns, ITT vs. per-protocol, audit trail) that surface in inspection
Documents that don't hold up against ICH E6(R2) GCP expectations
Important deviations not reconciled between the deviation log and the CSR
What TrialScope checks for you
GCP compliance
Checks documents against ICH E6(R2) Good Clinical Practice expectations and flags gaps.
Deviation classification
Reviews whether deviations are classified consistently against pre-defined important-vs-minor criteria.
Data integrity
Flags missing-data patterns, ITT vs. per-protocol handling, and reconciliation gaps that affect reliability.
Inspection-readiness
Surfaces the documentation gaps an inspector or auditor is most likely to cite.
SEE IT ON YOUR OWN DOCUMENT
Upload a protocol, CSR, manuscript, or briefing document and get an audit calibrated to quality assurance / gcp — findings, severities, and a verdict in under 90 seconds. Free to use.
Frequently asked questions
Can TrialScope support GCP and quality review?
Yes. It reviews trial documents against ICH E6(R2) Good Clinical Practice expectations, checks that protocol deviations are classified consistently, and flags data-integrity and reconciliation gaps that tend to surface in inspections — as decision-support, not a replacement for your QA judgment or a formal audit.
Does it classify protocol deviations?
It checks whether deviations are classified consistently against pre-defined important-vs-minor criteria and flags inconsistencies, concentrations at a site or arm, and gaps between the deviation log and the clinical study report. See our ICH-GCP protocol deviations guide for the framework it applies.
How is it calibrated for quality assurance?
Audits run through a QA/GCP persona, and corrections from verified quality professionals refine how it weights compliance and data-integrity findings over time.