Consistency and traceability, for medical writers.
Reconcile the numbers across synopsis, body, and tables, confirm the conclusions trace to the results, and check ICH E3 and CONSORT alignment — without reading the whole document three times.
TrialScope · live audit
📄 Clinical Study Report (ICH E3)🎯 Reviewing as: Medical Writer
VERDICT
Revise before circulation
FINDINGS
0 · 3 · 1
crit · major · minor
MAJORConsistency
Analyzed-population count differs between synopsis and Table 14.1
The synopsis reports N=412 analyzed; the efficacy table shows 408. The four-patient discrepancy isn't explained in the disposition narrative.
MAJORTraceability
Conclusion claims benefit beyond the primary result
The conclusion states a 'clinically meaningful improvement in quality of life,' but QoL was an exploratory endpoint reported without a confirmatory test.
MAJORStructure
Protocol-deviations summary missing from the disposition section
ICH E3 §10.2 expects a summary of important protocol deviations; the CSR lists them only in an appendix without a body summary.
MINORCONSORT
Trial registration identifier not stated in the abstract
The manuscript abstract omits the registry identifier, a CONSORT-for-abstracts item most journals require.
The review work that eats your week
Numbers that don't tie out between the synopsis, in-text results, and the tables
Conclusions that overstate or drift from the actual primary result
ICH E3 sections that are incomplete or out of expected structure
Manuscripts that miss CONSORT items reviewers will demand
What TrialScope checks for you
Internal consistency
Reconciles disposition counts, analysis-set numbers, and key results across the synopsis, body, and tables.
Traceability
Checks that every conclusion traces to a reported result and flags statements that outrun the evidence.
ICH E3 structure
Confirms the CSR carries the expected E3 sections and flags gaps in disposition, efficacy, and safety reporting.
CONSORT alignment
For manuscripts, checks the 25-item CONSORT 2010 set and the participant-flow diagram.
SEE IT ON YOUR OWN DOCUMENT
Upload a protocol, CSR, manuscript, or briefing document and get an audit calibrated to medical writer — findings, severities, and a verdict in under 90 seconds. Free to use.
Frequently asked questions
Can TrialScope review a clinical study report?
Yes. It checks a CSR against the expected ICH E3 structure, reconciles disposition and results numbers across the synopsis, body, and tables, and verifies that conclusions trace to the reported results — returning findings ranked by impact.
Does it help with manuscripts too?
Yes. For manuscripts it checks alignment with the CONSORT 2010 reporting guideline, including the participant-flow diagram and commonly missed items like effect sizes with confidence intervals and trial registration.
How is it calibrated for medical writing?
Audits run through a medical-writer persona, and corrections from verified medical writers refine how it prioritizes consistency, traceability, and reporting-completeness findings.