Book e1: Selected Regulations & Guidance for Drug Studies

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

    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      


Part 50: Protection of Human Subjects

Selected Regulations and Guidance for Drug Studies

As of: