IRB Protocol Compliance Audit Analyst
Audit research protocols for regulatory compliance automatically
by nextlevelbuilderResearch & AcademiaAcademic ServicesInstitutional Review Board AdministratorAuditingWhat You Can Do
You submit your research protocol (or protocol summary) and this skill systematically audits it against IRB regulations, federal guidelines, and institutional standards. It identifies compliance gaps, categorizes risks by severity (critical, major, minor), and generates specific corrective action recommendations. You receive a structured audit report organized by regulatory domain with actionable guidance.
Features
Maps all protocol elements against CFR 45 Part 46, ICH-GCP, FDA guidance, and institutional policies
Classifies findings into Critical (immediate action required), Major (significant gap), and Minor (best practice) severity levels
Identifies missing required elements like informed consent procedures, safety monitoring plans, and data protection measures
Recommends specific, actionable corrections with implementation guidance and regulatory justification
Documents each finding with evidence, regulatory citation, and cross-reference to protocol section
Compares your protocol against institutional best practices and similar study types
Creates concise overview for leadership with compliance status, risk level, and timeline to resolution
Example Output
Audit Summary
| Category | Critical | Major | Minor | Status |
|---|---|---|---|---|
| Consent & Ethics | 1 | 2 | 3 | ⚠️ Needs Action |
| Safety Monitoring | 0 | 1 | 2 | ⚠️ Needs Action |
| Data Protection | 0 | 0 | 4 | ✓ Compliant |
| Recruitment | 1 | 0 | 1 | ⚠️ Needs Action |
Critical Findings (Immediate Action Required)
C-001: Missing Data Protection Plan
- Regulation: CFR 45.102(a)
- Gap: Protocol lacks de-identification procedures for participant data
- Risk: Potential breach of privacy regulations
- Corrective Action: Add Section 7.3 describing data linkage codes, access controls, and retention schedule
Major Findings (Significant Gaps)
M-001: Adverse Event Monitoring Procedure Incomplete
- Regulation: ICH-GCP 4.11.2
- Gap: No definition of what constitutes reportable events or timeline for escalation
- Risk: Delayed identification of safety issues
- Corrective Action: Include DSMB charter and monthly safety review meeting schedule
Timeline to Compliance
Critical findings must be resolved within 10 days. Submit revised protocol to IRB for expedited review.
What's Included
- Protocol analysis engine: Systematic review of all protocol elements against regulatory requirements
- Regulatory compliance database: Coverage of CFR 45, ICH-GCP, FDA guidance documents, and institutional policies
- Risk assessment framework: Severity classification system with regulatory justification for each finding
- Corrective action templates: Pre-formatted recommendations aligned with regulatory expectations and institutional standards
- Audit report generator: Professional formatted reports with executive summary, detailed findings, and action items
- Compliance tracking checklist: Itemized checklist of required elements mapped to your protocol sections
Who It's For
- IRB coordinators and administrators
- Research integrity officers
- Principal investigators and research teams
- Compliance and regulatory affairs professionals
- Graduate program directors and research mentors
Best For
- Initial protocol reviews before IRB submission
- Pre-submission compliance verification
- Risk assessment and mitigation planning
- Periodic compliance audits and ongoing monitoring
- Corrective action documentation and tracking
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