MyeRegs

Selected Regulations & Guidance for Drug Studies (trial)

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Selected Regulations and Guidance for Drug Studies

As of:

  • 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