Book 6:  The EU Directives on GCP, Selected EU Guidances and the Declaration of Helsinki

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Table of Contents

• European Directives on GCP
       2001/20/EC, adopted April 4, 2001
       2005/28/EC  adopted April 8, 2005
                        
• Implementing Guidances for the EU Directives
      • Detailed Guidance on the Collection, Verification, and
        Presentation of Adverse Reaction Reports Arising from
        Clinical Trials on Medicinal Products for Human Use
       
       • Detailed Guidance on the European Database of Suspect
         Unexpected Serious Adverse Reactions

       • Detailed Guidance on the Application Format and
         Documentation to be Submitted in an Application for an Ethics
         Committee Opinion on a Clinical Trial on Medicinal Products for
         Human Use 

• ICH Guidelines (EU-adopted versions)
       E6     Good Clinical Practice
       E2A  Clinical Safety Data Management: Definitions and
                Standards for Expedited Reporting
       E8     General Considerations for Clinical Trials

• Declaration of Helsinki (World Medical Association, 2000)