Protocol Review Compliance Assistant
Review research protocols for compliance, regulatory adherence, and ethical soundness
by nextlevelbuilderResearch & AcademiaAcademic ServicesInstitutional Review Board AdministratorProtocol ReviewWhat You Can Do
This skill rapidly evaluates research protocols against regulatory standards, ethical guidelines, and industry best practices. It identifies compliance gaps, flags methodological concerns, and generates structured recommendations for improvement. You'll receive a comprehensive compliance assessment that streamlines protocol reviews and reduces the risk of regulatory violations or IRB rejection.
Features
Evaluates protocols against FDA, NIH, HIPAA, EPA, and other applicable regulatory frameworks specific to your study type and jurisdiction.
Assesses informed consent adequacy, IRB considerations, vulnerable population protections, and research ethics alignment with institutional policies.
Reviews study design, statistical power justification, sample size calculations, and analytical approach for scientific rigor and feasibility.
Flags potential safety hazards, legal exposure, operational challenges, and participant protection gaps before submission.
Rates overall protocol readiness on a 0-100 scale with dimensional breakdowns (regulatory, safety, ethics, methodology, documentation).
Provides detailed findings of missing sections, inadequate content, and areas requiring strengthening with specific location references.
Delivers actionable revision suggestions sorted by criticality—critical (must fix), major (should fix), and minor (consider) categories.
Confirms presence and quality of required protocol components: safety plans, adverse event procedures, data management, and conflict of interest disclosures.
Example Output
Compliance Assessment Report
Overall Compliance Score: 76/100
Critical Findings (Must Address Before Submission)
- ❌ Informed Consent Form lacks adequate description of serious adverse event risks for vulnerable populations
- ❌ Safety monitoring plan does not specify serious adverse event (SAE) reporting timeline or escalation procedure
Major Findings (Should Address)
- ⚠️ Statistical power calculation missing for primary outcome measure
- ⚠️ Data retention and destruction procedures incomplete
Minor Findings (Consider)
- ℹ️ Timeline doesn't specify interim analysis schedule
- ℹ️ Conflict of interest disclosures need expansion
Recommendations
- Revise ICF: Add specific risk descriptions for participants age 65+, including rates from comparable studies
- Add SAE Protocol: Define 24-48 hour reporting window and escalation to Data Safety Monitoring Board
- Include Power Analysis: Justify sample size N=250 with α=0.05, β=0.20 for primary endpoint
- Strengthen Data Plans: Specify 7-year retention, secure destruction method, backup procedures
What's Included
- Regulatory Framework Analysis: Checks your protocol against FDA guidelines, NIH regulations, EPA standards, and other applicable frameworks for your research type.
- Compliance Scoring Engine: Quantifies protocol readiness with a 0-100 score and detailed dimensional breakdown across regulatory, safety, ethics, and methodology domains.
- Comprehensive Gap Report: Lists missing sections, insufficient content depth, unclear procedures, and risk areas organized by severity and section.
- Actionable Recommendations: Provides specific, copy-paste-ready revision suggestions prioritized as critical, major, or minor for IRB and regulatory reviewers.
- Documentation Checklist: Validates presence and adequacy of required components: informed consent, safety monitoring, adverse event procedures, and disclosure statements.
- Safety & Ethics Assessment: Evaluates participant protection, conflict of interest handling, data privacy compliance, and ethical considerations specific to your population.
Who It's For
- Protocol Compliance Officers
- Clinical Research Coordinators
- IRB/Ethics Committee Members
- Regulatory Affairs Specialists
- Principal Investigators
Best For
- Pre-submission protocol quality checks
- IRB/Ethics board compliance assessment
- FDA regulatory pathway readiness evaluation
- Protocol revision planning and prioritization
- Multi-site study harmonization and consistency
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