Audit Trail Review
See What Changed.
Know What Needs Attention.
Move beyond raw audit logs with study-wide visibility into repeated, late, post-review, and critical-data changes. Identify risk patterns across sites, subjects, and users, drill into the underlying records, and support ICH E6(R3)-aligned audit trail review.
— Why Clinion Audit Trail Review?
Oversight That Stands Up to Inspection
Clinion ATR helps teams find the changes that need attention, see where risk is emerging, and investigate the underlying activity before it becomes a bigger issue. All within Clinion EDC.
E6(R3)
Built for the Standard
Designed to support ICH E6(R3) audit trail review and give teams the proactive oversight needed to stay ready for inspection.
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Programming to Investigate
Ask questions in plain language, explore patterns, and drill down to the underlying record without writing SQL or relying on a programmer for every new view.
One Platform
EDC-Native Review
Review audit trail activity where your study data already lives. No separate system, no data exports, and no reconciliation between platforms.
— Features
A More Focused Way to Review Audit Activity
From study-wide monitoring and targeted risk views to Ask ATR and Inspection Readiness Reports, Clinion ATR helps teams surface meaningful patterns, investigate the activity behind them, and carry findings through to inspection preparation.
STUDY-WIDE MONITORING
Understand What’s Changing Across Your Study
Turn high-volume audit data into a clear view of study activity. See how much data is changing, where activity is concentrated, how late changes are being made, and who is making them, so your team can quickly focus on areas that need closer review.
Get a consolidated view of key audit metrics, activity trends, first-time entries versus updates, active users, subjects, and risk indicators to understand the overall pattern of study activity.
See where audit activity is concentrated across sites, visits, CRF pages, and fields, with first-time entries, updates, and deleted records clearly distinguished.
Focus on changes made well after the initial entry. Set a duration threshold, see where late changes are concentrated across sites, visits, pages, fields, and users, and drill into the records with the longest delays.
See who is entering or changing data and when that activity is taking place. Compare activity across users and identify unusual timing or entry patterns that may warrant closer review.
RISK-FOCUSED OVERSIGHT
See Where Data Integrity, Safety, and Timeliness Need Attention
Move from broad audit monitoring to the activity that deserves closer attention. Clinion ATR brings together correction patterns, post-review changes, critical data, reporting delays, investigator activity, and query behavior so teams can identify emerging issues and decide where follow-up is needed.
Compare sites by correction volume and risk level and use configurable thresholds to quickly see where repeated data changes may warrant closer review.
Track data modified after review and see where review breaks are occurring across sites, subjects, pages, and users, including changes after SDV, investigator, and data management review. See review-break trends, repeat breaks, and after-hours activity to understand where reviewed data continues to change.
Keep critical forms under closer watch. See corrections, affected sites, change patterns, and after-hours activity separately from the wider audit trail so important data does not get lost in overall study volume.
See how long it takes for adverse events and serious adverse events to be entered into EDC. Compare delays across sites and drill into individual records that may need follow-up.
Tracks how long after a visit data is actually submitted, surfacing unsubmitted pages, saved-but-never-finalized pages, and the sites, visits, and subjects with the longest delays. Stale, uncaptured data is flagged before it stalls database lock.
Surface data changes made without an open query and understand where they are concentrated across sites, subjects, visits, pages, and fields.
Track unsigned eCRFs, review delays, investigator inactivity, and the oldest records still awaiting review so teams can follow up before backlogs continue to build.
Monitor cancelled and auto-generated query patterns across sites to identify unusually high cancellation activity, unresolved queries, and areas where query quality or follow-up may need attention.
UNIFIED DRILLDOWN
Go From Any Signal to the Records Behind It
When something needs a closer look, Unified Drilldown takes you directly to the underlying audit records. Narrow the data by site, subject, visit, CRF, user, date, or record type to understand exactly what changed, when it changed, who changed it, and why.
Narrow audit records by site, subject, visit, CRF/page, user, and date, or search for a specific field, subject, or user.
Switch between all records, corrections, and first-time entries to focus the investigation on the activity you need to review.
Review the previous value, new value, reason for change, timestamp, user, and record type alongside the study context.
Export the filtered records to Excel for further review, documentation, or team follow-up.
ASK ATR
Ask Your Audit Trail. Get to the Evidence Faster.
Explore audit activity using natural-language questions instead of manually searching across dashboards and records. Ask ATR can answer a study-specific question, return the relevant records, and visualize the pattern so reviewers can investigate further from the same analysis.
Ask specific questions about audit activity, such as how often a review lock was revoked or where a particular pattern is occurring.
Move beyond a summary answer to the audit records associated with the result, making it easier to understand what is driving the pattern.
Turn the result into a chart to see how activity changes over time and make patterns easier to interpret.
Save useful analyses to a Custom Dashboard so frequently reviewed metrics and patterns remain easy to access.
INSPECTION READINESS REPORT
Turn Ongoing Review Into Inspection-Ready Evidence
Bring the findings from your audit trail review into a structured view of study readiness. Generate reports over time to see what still needs attention, whether identified risks are improving, and how readiness has changed since the previous review.
See an overall readiness score together with the change from the previous report for a quick view of study progress.
Surface critical findings and the sites or areas where further review or follow-up is still required.
Compare successive reports to see whether issues such as corrections, reporting delays, unsigned forms, and other identified risks are decreasing.
Maintain a record of readiness assessments over time, helping teams demonstrate that findings were identified, followed up, and reassessed.
— See Clinion ATR in action
Audit Trail Review Product Walkthrough
From Study Signals to Inspection Readiness
See how Clinion ATR brings study-wide monitoring, risk-focused review, record-level investigation, Ask ATR, and Inspection Readiness Reports together in one connected experience. Follow how teams move from identifying unusual audit activity to understanding the records behind it and documenting ongoing oversight within Clinion EDC.
— FAQS
Frequently Asked Questions (FAQ)
Clinion Audit Trail Review (ATR) is a review and analytics capability within Clinion EDC that helps teams make sense of audit trail activity across a study. It brings changes, delays, user activity, review breaks, and other risk signals into focused views so reviewers can quickly see what may need attention and investigate further.
A standard audit trail records what changed, when it changed, who changed it, and why. Clinion ATR goes further by analyzing those records to surface patterns such as repeated or late changes, post-review modifications, changes to critical data, and site or user activity that may require closer review.
No. Clinion ATR is designed to work within Clinion EDC, keeping audit trail monitoring, risk-focused review, and record-level investigation connected to the study data being reviewed.
Clinion ATR is designed to support ICH E6(R3)-aligned audit trail review by helping teams take a more systematic, risk-focused approach to reviewing data changes, investigating relevant activity, and maintaining visibility into findings over time.
Clinion ATR can surface high correction activity, late data changes, post-review changes, activity on critical CRFs, AE entry delays, data-entry delays, unqueried changes, unsigned forms, investigator inactivity, and unusual query patterns.
Yes. Ask ATR lets reviewers explore audit trail activity using natural-language questions. It can return relevant records and visualize trends, helping teams investigate specific sites, users, review events, or change patterns without manually building a new analysis each time.
Yes. Unified Drilldown lets reviewers move from study-level trends and risk views to the underlying audit records. Records can be narrowed by site, subject, visit, CRF, user, date, and record type to understand the context behind a change.
The Inspection Readiness Report brings key ATR findings into a structured view of study readiness. Teams can review outstanding findings, compare results across review periods, and see whether identified risks are improving or still require follow-up.
Still have questions?
Explore how Clinion AI can accelerate your trial – reach out to our team.
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See Clinion ATR in Action
See how Clinion ATR turns audit activity into clearer oversight, faster investigation, and stronger inspection readiness.