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
Click here to see an enlarged pdf cover