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Selected Regulations and Guidance for Drug Studies
As of:
12/2/2024
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FDA Regulations, CFR Title 21
Part 11: Electronic Records; Electronic Signatures
Part 50: Protection of Human Subjects
Part 54: Financial Disclosure by Clinical Investigators
Part 56: Institutional Review Boards
Part 312: Investigational New Drug Application
Part 314: Applications for FDA Approval to Market a New Drug
ICH Guidelines (US, Step 5)
ICH E6(R3): Good Clinical Practice (ICH Step 4, 1/6/2025)
ICH E6(R2): Integrated Addendum to E6(R1): Guideline for Good Clinical Practice
ICH E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting
FDA Guidance
A Risk-Based Approach to Monitoring
FDA Regulations, CFR Title 21
Part 11: Electronic Records; Electronic Signatures
Part 50: Protection of Human Subjects
Part 54: Financial Disclosure by Clinical Investigators
Part 56: Institutional Review Boards
Part 312: Investigational New Drug Application
Part 314: Applications for FDA Approval to Market a New Drug
ICH Guidelines (US, Step 5)
ICH E6(R3): Good Clinical Practice (ICH Step 4, 1/6/2025)
ICH E6(R2): Integrated Addendum to E6(R1): Guideline for Good Clinical Practice
ICH E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting
FDA Guidance
A Risk-Based Approach to Monitoring
