Compliance Monitoring Center
AI Compliance Assistant
I've detected 3 potential protocol deviations in the past week that require attention. The most critical relates to missing documentation for patient consent revisions in FLUX-CT-2025-002. Would you like me to generate a remediation plan?
Protocol Deviations
AI-detected issues requiring review.
| Severity | Issue | Trial | Detected | Status | Actions |
|---|---|---|---|---|---|
| High | Missing consent revision documentation | FLUX-CT-2025-002 | Apr 18, 2025 | In Progress | |
| Medium | Protocol visit window deviation | FLUX-CT-2025-001 | Apr 17, 2025 | Resolved | |
| Medium | Inconsistent adverse event documentation | FLUX-CT-2025-003 | Apr 16, 2025 | In Progress | |
| Low | Missing investigator signature | FLUX-CT-2025-002 | Apr 15, 2025 | Pending | |
| Low | Delayed data entry | FLUX-CT-2025-001 | Apr 14, 2025 | Resolved |
Documentation Gap Analysis
AI-detected missing or incomplete documentation.
FLUX-CT-2025-002: Consent Documentation
Missing documentation for protocol amendment #3 patient reconsent process. Required by IRB guidelines section 4.2.
AI Recommendation: Update the patient reconsent documentation to include specific reference to the changes in dosing schedule introduced in amendment #3. Template available in document library.
FLUX-CT-2025-003: Adverse Event Documentation
Inconsistent adverse event grading between source documentation and CRF entries for 3 participants at site 102.
AI Recommendation: Schedule site-specific training on CTCAE v5.0 grading criteria. Update monitoring plan to include focused source data verification for adverse events.
Regulatory Compliance
Automated compliance tracking.
FDA 21 CFR Part 11
96% CompliantICH GCP E6(R2)
83% CompliantGDPR
98% CompliantIRB Requirements
78% CompliantAI Alert: New ICH GCP E8(R1) guidelines released. 14 documents require updates.
AI Insights
Proactive recommendations based on document analysis.
Protocol Deviation Trend
A pattern of visit window deviations has been detected across 3 sites. Consider protocol amendment to adjust visit windows by +/- 3 days to improve compliance.
Documentation Template Issue
The adverse event reporting form (v2.1) is missing fields required by recent FDA guidance on COVID-19 trial conduct. Update needed before next monitoring visit.
IRB Correspondence Analysis
Based on previous IRB queries for similar studies, prepare for potential questions on exclusion criteria #4 and #7 in upcoming submission.
Upcoming Deadlines
Regulatory and documentation due dates.
-
IRB Annual Report Due
FLUX-CT-2025-001
Tomorrow
-
DSMB Report Submission
FLUX-CT-2025-002
Apr 25, 2025
-
Protocol Amendment Submission
FLUX-CT-2025-003
Apr 30, 2025