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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
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