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Free 1-day Trial: Selected Regulations & Guidance for Drug Studies

•  CFR Title 21:  Food and Drugs (As of yesterday's date)

Parts
11    Electronic Records/Electronic Signatures 
50    Protection of Human Subjects
54    Financial Disclosure
56    Institutional Review Boards 
312  Investigational New Drug Application
314  Applications for FDA Approval to Market a New Drug 

•  ICH Guidelines (US, Step 5)

E6(R2)     Good Clinical Practice (Includes R2 Addendum)
E2A   Clinical Safety Data Management: Definitions and Standards for Expedited Reporting

•  Additional FDA Guidance Documents:

  • Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring 
  • Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency

 

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Book e1: Selected Regulations & Guidance for Drug Studies

•  CFR Title 21:  Food and Drugs (As of yesterday's date)

Parts
11    Electronic Records/Electronic Signatures 
50    Protection of Human Subjects
54    Financial Disclosure
56    Institutional Review Boards 
312  Investigational New Drug Application
314  Applications for FDA Approval to Market a New Drug 

•  ICH Guidelines (US, Step 5)

E6(R2)     Good Clinical Practice (Includes R2 Addendum)
E2A   Clinical Safety Data Management: Definitions and Standards for Expedited Reporting

•  Additional FDA Guidance Documents:

  • Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring 
  • Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency

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Book e2: Selected Regulations & Guidance for Device Studies

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Part 50: Protection of Human Subjects

Selected Regulations and Guidance for Drug Studies

As of: