Research Compliance Audit Generator
Automate research protocol compliance audits across policies, funders, and regulations.
What You Can Do
Feed Claude your research protocol documents alongside institutional policies, funder guidelines (NSF, NIH, DOE, DOD), and regulatory checklists to receive systematic compliance audits. The skill performs cross-referencing to surface compliance gaps, missing documentation, policy conflicts, and risk areas—accelerating your pre-submission review cycle and reducing rejection rates. Designed for research administrators managing complex, multi-layered compliance landscapes across IRB/IACUC protocols, export controls, and evolving regulatory frameworks.
Features
Maps your research protocol against institutional policies, funder-specific requirements, and regulatory frameworks to identify alignment gaps
Flags missing documentation, incomplete sections, and unmet compliance requirements before official submission
Highlights high-risk compliance issues, policy conflicts, and regulatory red flags by severity and likelihood of rejection
Validates protocols against NSF, NIH, DOE, DOD, and other funder-specific requirements simultaneously
Identifies ITAR, EAR, and CFDA considerations for international collaborations and sensitive research areas
Surfaces contradictions between institutional policies, funder requirements, and regulatory frameworks that require resolution
Generates structured compliance audit reports with checkpoints, findings, and remediation recommendations for submission readiness
Example Output
Example 1: NSF-Funded Materials Science Protocol
- ✅ Protocol title and objectives clearly stated
- ❌ Gap: Broader Impacts statement insufficient — NSF requires 1-2 pages; current version is 3 sentences
- ⚠️ Risk: Data management plan references outdated institutional repository — Verify compatibility with current institutional standards
- ✅ Budget justification aligns with NSF guidelines
- ❌ Gap: Conflict of interest disclosures incomplete — Missing co-investigator COI forms (3 of 5 required)
Example 2: Multi-Institutional Biomedical Study
- ✅ IRB protocol approved at primary institution
- ❌ Policy conflict detected — Partner institution requires additional HIPAA attestation absent from submission
- ⚠️ Risk: International data transfer procedures unclear — Current protocol does not address Partner Institution B's data residency requirements
- ✅ Human subjects protections documentation complete
- ❌ Gap: Regulatory framework mismatch — Protocol references outdated 2020 NIH guidance; 2023 updates require revisions to recruitment language
What's Included
- SKILL.md instruction file with protocol audit methodology and compliance frameworks:
- Protocol Audit Checklist Template covering IRB/IACUC, funder requirements, and institutional policies:
- Compliance Gap Documentation Worksheet for organizing findings by severity and remediation steps:
- Multi-Funder Requirement Matrix (NSF, NIH, DOE, DOD) for quick cross-referencing:
- Export Control & International Research Screening Worksheet for ITAR, EAR, and CFDA assessments:
- Policy Conflict Resolution Guide for identifying and escalating contradictions between institutional and funder rules:
Who It's For
- Research administrators managing pre-submission protocol reviews and compliance workflows
- Principal investigators preparing grant proposals for NSF, NIH, DOE, or DOD funding
- IRB/IACUC coordinators verifying protocol completeness before official institutional review
- Compliance officers conducting institutional audits or accreditation preparations
- Research operations managers onboarding new faculty and researchers on compliance requirements
Best For
- Pre-submission protocol compliance audits for federal funding (NSF, NIH, DOE, DOD)
- IRB/IACUC protocol completeness verification before official submission
- Multi-institutional research compliance checks and coordinated cross-institution reviews
- Identifying institutional policy impact on active or pipeline protocols
- Export control and international research collaboration compliance screening
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