IRB Compliance Protocol Assessment and Documentation
Assess IRB protocols and generate compliant research documentation
What You Can Do
This skill evaluates your research protocols against institutional review board requirements, identifies compliance gaps, and generates the documentation needed for IRB submission. You receive a detailed assessment report, risk analysis, and ready-to-use documentation templates tailored to your specific research design.
Features
Evaluate your research protocol against current IRB regulations, institutional policies, and ethical standards to identify areas of compliance and concern.
Automatically detect missing elements, unclear procedures, or inconsistencies that could delay IRB approval and receive targeted guidance to fix them.
Generate IRB-compliant forms, informed consent templates, safety protocols, and risk mitigation strategies customized to your research type and population.
Receive specific references to applicable regulations (45 CFR 46, ICH-GCP, GDPR) and institutional policies relevant to your protocol.
Systematically assess research risks including harm to subjects, privacy concerns, and data security vulnerabilities with mitigation recommendations.
Get a prioritized checklist of all IRB submission requirements with status tracking so you know exactly what's ready and what still needs work.
Customize standard IRB templates to fit your specific research design, population, and institutional requirements without starting from scratch.
Example Output
Compliance Assessment Summary
- Subject Protection: COMPLIANT (informed consent addresses all required elements)
- Risk Assessment: PARTIAL GAP (missing privacy safeguards for sensitive data)
- Study Design: COMPLIANT (randomization and blinding procedures clearly described)
- Data Management: NON-COMPLIANT (security plan lacks HIPAA alignment)
Generated Informed Consent Template
INFORMED CONSENT FORM
Research Study: [Study Title]
Principal Investigator: [PI Name]
Why are you being invited to participate?
You are invited because [reason based on inclusion criteria]...
What will participation involve?
If you agree to participate, you will:
1. [Procedure 1] (approximately [duration])
2. [Procedure 2] (approximately [duration])
...
What are the risks and benefits?
Risks include: [list specific risks]
Benefits may include: [describe potential benefits]
Prioritized Gap Analysis
- CRITICAL: Data encryption protocol not specified for electronic health information
- MAJOR: Compensation structure needs written justification to prevent undue inducement
- MAJOR: Recruitment process lacks diversity monitoring documentation
- MINOR: Adverse event timeline could be more specific
What's Included
- Compliance Assessment Template: Structured framework for evaluating protocols against regulatory requirements and institutional standards.
- Gap Analysis Report: Detailed identification of missing elements, risk areas, and non-compliant sections with remediation guidance ranked by priority.
- IRB Documentation Templates: Ready-to-customize forms including informed consent, protocol summary, risk assessment, and safety monitoring plans.
- Regulatory Reference Guide: Quick-access citations of applicable federal regulations, FDA guidance, and institutional policies specific to your institution.
- Risk Mitigation Workbook: Step-by-step framework for identifying and documenting mitigation strategies for each identified research risk.
- Submission Readiness Tracker: Prioritized checklist of all IRB requirements with completion status and targeted notes for each item.
Who It's For
- Principal Investigators preparing IRB submissions
- Research Coordinators managing protocol preparation and compliance
- IRB Committee members reviewing protocols for completeness
- Compliance Officers ensuring regulatory adherence
- Research Administrators overseeing multi-protocol governance
Best For
- Initial protocol assessment and compliance screening
- Identifying and documenting compliance gaps before submission
- Preparing informed consent forms and required documentation
- Risk analysis and mitigation strategy development
- Protocol amendments and continuing review preparation
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