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Selected Regulations and Guidance for Drug Studies
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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(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
Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency
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(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
Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency
