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Book 6:  2023 Clinical Trials in The EU: Selected Legislation, Guidelines and the Declaration of Helsinki

Book 6: 2023 Clinical Trials in The EU: Selected Legislation, Guidelines and the Declaration of Helsinki

$ 19.95

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This spiral-bound, 5" x 7.5" book is a compilation of the European Union Directives, implementing guidances and ICH guidelines governing the conduct of clinical research in the EU. It includes such topics as:

• Good Clinical Practice/ Protection of Human Subjects
• General considerations for clinical trials
• Safety monitoring and reporting

Who Uses this Book and How?
• Clinical Research staff, as job aids
• Training departments, as training handouts
• Human Resources, as part of new-employee orientation
• Legal/Regulatory/QA staff, for company-wide distribution

What's the Price?
• 1-249 copies:  $17.95             • 250-499 copies:  $16.95
• 500-749 copies: $15.95          • 750+ copies:  $14.95

Custom Cover Prices*?
• 1-24 copies:  unavailable             • 25-100 copies:  $2.00/book
• 100-249 copies: $1.00/book        • 250+ copies:  No charge

* Based on quantities of a single book title

• EU Regulation No. 536/2014 of 16 April 2014 on Clinical Trials on Medicinal
  Products for Human Use, and Repealing Directive 2001/20/EC

• Declaration of Helsinki

• 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 

• Guidances for Regulation 536/2014
      • Questions and Answers on Clinical Trials Regulation (EU) No 536/2014
         May 2022

• ICH Guidelines (EU-adopted versions)
       E6     Good Clinical Practice (R2)
       E2A  Clinical Safety Data Management: Definitions and
                Standards for Expedited Reporting
       E8     General Considerations for Clinical Trials

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