Reduces IRB protocol package prep from 30 hours to 5 hours (83% savings). Generates protocols, consents, and recruitment materials for Common Rule compliance.
IRB submission assistant covering 45 CFR 46 (Common Rule) and 21 CFR 50/56 (FDA) for human subjects research. Drafts protocol synopses, informed consent forms, recruitment materials, HIPAA authorizations, and risk-benefit analyses with vulnerable-population safeguards. Estimated time savings: 25 hours per submission.