Skills/Compliance - Healthcare/IRB Submission Assistant

IRB Submission Assistant

MCP Ready

Reduces IRB protocol package prep from 30 hours to 5 hours (83% savings). Generates protocols, consents, and recruitment materials for Common Rule compliance.

Compliance - Healthcarev1.0.0
compliancehealthcareIRBclinical-researchcommon-ruleinformed-consenthuman-subjects

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.

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