IRB Compliance Advisor
Streamline IRB protocol reviews and compliance documentation for research administrators
What You Can Do
This skill helps research administrators prepare IRB submissions, review informed consent forms for regulatory compliance, classify and document adverse events, and maintain audit-ready compliance records. You'll reduce protocol review cycles by ensuring submissions meet 45 CFR 46 requirements upfront and accelerate compliance documentation workflows with regulatory-aligned templates.
Features
Analyze IRB protocol submissions against 45 CFR 46 regulatory requirements and identify missing documentation, risk assessment gaps, and amendment needs before formal review
Verify consent forms meet regulatory elements, assess readability (Flesch-Kincaid scoring), and flag missing disclosures or non-compliant language
Classify reported events as serious or non-serious, determine regulatory reporting timelines, and generate compliance documentation for IRB submission
Auto-generate customized compliance checklists based on protocol type (expedited, full review, exempt determination) and risk level
Identify compliance risks specific to your protocol (vulnerable populations, multi-site coordination, data security) and recommend mitigation strategies
Access pre-built IRB submission forms, adverse event reports, protocol amendments, and staff training materials aligned with federal requirements
Generate audit checklists with evidence requirements and common findings to avoid, helping you prepare documentation verification before inspections
Example Output
Example 1: Protocol Review Finding
- ⚠️ Risk Assessment Incomplete Your protocol mentions recruitment from a vulnerable population (pregnant women) but lacks specific risk minimization strategies required by 45 CFR 46.204. Recommended language: "Recruitment will be conducted via prenatal clinics with written information about study risks. Consent will be documented in non-pressured clinical settings." [link to 45 CFR 46.204]
Example 2: Consent Form Gap
- ❌ Missing Element: Description of Reasonably Foreseeable Risks Your form states "mild discomfort possible" but doesn't specify expected frequency or severity. Recommendation: "Approximately 30% of subjects experience mild dizziness lasting 5-10 minutes after the intervention. No serious risks have been observed in prior studies (n=200)."
Example 3: Adverse Event Classification
✓ Non-Serious Adverse Event (Continue Monitoring) Subject headache during study visit: mild intensity, resolved with acetaminophen within 2 hours, no hospitalization. Reporting timeline: Document in next IRB continuing review. Action: No expedited reporting required.
What's Included
- 45 CFR 46 Compliance Framework: Comprehensive checklist aligned with Common Rule requirements for protocol review, informed consent, and adverse event reporting
- Informed Consent Template Library: Multiple format examples for standard research, minimal-risk studies, and vulnerable populations; includes required element checklist and readability assessment tool
- Adverse Event Documentation Guide: SAE/non-SAE classification criteria, reporting timeline matrix, required documentation fields, and submission templates
- Regulatory Reference Library: Quick-access summaries of 45 CFR 46 sections, FDA guidance documents (when applicable), and Common Rule updates
- IRB Submission Templates: Protocol amendment forms, continuing review documentation, protocol deviation reports, and multi-site coordination templates
- Audit Preparation Toolkit: Customizable audit readiness checklists by study phase, evidence verification worksheets, and common findings mitigation guides
Who It's For
- Research Administrators
- IRB Compliance Officers
- Clinical Research Coordinators
- Grant Managers and Regulatory Specialists
- IRB Chairs and Committee Members
Best For
- Pre-submission Protocol Compliance Review
- Informed Consent Form Analysis and Revision
- Adverse Event Classification and Documentation
- Compliance Audit Preparation and Evidence Verification
- Staff Training on IRB Regulations and Procedures
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