Clinical Trial Data Validation & Query Resolution
Validate clinical trial data against protocol specs and resolve discrepancies for FDA compliance
What You Can Do
You can automate the validation of clinical trial data against protocol specifications, identify discrepancies including missing values, out-of-range results, protocol violations, and CRF inconsistencies. The skill generates audit-ready query documentation, categorizes anomalies by severity and type, resolves root causes systematically, and produces FDA inspection-ready reports that trace every data decision and corrective action for CDISC and regulatory submission.
Features
Checks inclusion/exclusion criteria, dosing rules, visit windows, and CRF completion requirements against study protocol
Automatically classifies query types (missing data, range errors, logical inconsistencies, source mismatch) for systematic resolution
Flags critical adverse events and lab values for urgent review separate from administrative data issues
Creates traceable, timestamped records of every query, decision, and corrective action for audit trails
Identifies non-adherence patterns (missed visits, ineligible subjects, dose deviations) across study population
Formats validation reports and query logs to CDISC standards for seamless regulatory submission
Ensures queries and data handling follow Good Clinical Practice standards to prevent regulatory findings
Systematically determines source of discrepancies (data entry error, missing source docs, protocol misunderstanding)
Example Output
Example 1: EDC Download Validation Report
Subject ID: 001-0045 | Visit: Week 12 | Status: HOLD
- ⚠️ CRITICAL SAFETY QUERY
- Lab Value Out of Range: ALT 245 U/L (protocol limit: <3x ULN = 120 U/L)
- Query Type: Range Error
- Action Required: Obtain source documentation, verify AE reporting
- Priority: Urgent (safety)
- ⚠️ DATA INTEGRITY QUERY
- Missing CRF Section: Concomitant Medications Visit 12
- Query Type: Incomplete Data
- Expected Source: Subject diary + pharmacy records
- Assigned to: Site Coordinator
Example 2: Protocol Deviation Summary
- 🚫 PROTOCOL VIOLATION DETECTED
Subject 002-0078: Inclusion Criterion Breach
- Criterion: eGFR ≥30 mL/min/1.73m²
- Baseline Value: 28 mL/min/1.73m² (SOURCE: Lab 2024-01-15)
- Deviation Type: Ineligible subject enrolled
- Regulatory Impact: Major (affects subject safety assessment)
- Resolution: Withdraw subject per protocol section 5.2
Example 3: Query Resolution Log
- ✅ RESOLVED QUERY #CRF-2024-0156
Original Issue: Dosing schedule discrepancy (5mg vs 10mg Day 1)
Root Cause: Data entry error + missing source document signature
Resolution: Corrected EDC to 5mg per source, obtained signed SOP confirmation
Resolved By: CRA Smith | Date: 2024-02-20 14:32 UTC | Audit Trail: Locked
What's Included
- SKILL.md instruction file: Complete clinical trial data validation protocol
- Protocol Compliance Checklist: ICH-GCP and protocol requirement validation matrix
- Query Resolution Template: Structured log for categorizing, investigating, and documenting discrepancies
- Risk-Based Prioritization Framework: Safety vs. administrative query triage matrix
- Deviation Report Generator: Regulatory-ready protocol deviation documentation with audit trails
Who It's For
- Clinical Research Associates (CRAs) — Managing data validation workflows and query resolution across sites
- Data Managers — Overseeing EDC database cleanup and CDISC submission readiness
- Quality Assurance/Compliance Specialists — Auditing data integrity and regulatory inspection preparation
- Regulatory Affairs Professionals — Preparing inspection-ready documentation and FDA communications
- Clinical Trial Coordinators — Resolving site-level discrepancies and protocol deviations
Best For
- EDC data validation after each study visit to catch discrepancies before database lock
- Protocol deviation identification across enrolled subjects for enrollment and safety compliance
- Safety data review prioritizing adverse events and lab anomalies for urgent assessment
- Query documentation creating audit-ready records for FDA inspection and regulatory submission
- Inclusion/exclusion criterion verification ensuring enrolled subjects meet study eligibility
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