EudraLex – Volume 10 Clinical trials guidelines

Volume 10 of the publications “The rules governing medicinal products in the European Union” contains guidance documents applying to clinical trials.

Chapter I: Application and Application Form

 Chapter II: Monitoring and Pharmacovigilance

Detailed guidance on the collection, verification and presentation of adverse event/reaction reports arising from clinical trials on medicinal products for human use (‘CT-3’)  [2 MB] Translations. (June 2011)

ICH guideline E2F – Note for guidance on development safety update reports (September 2010)
To give additional support, ICH has established ‘model DSURs’ which are accessible here. These ‘model DSURs’ take account of the differing knowledge about a medicine, depending on whether the sponsor holds the marketing authorisation or not.

Chapter III: Quality of the Investigational Medicinal Product

Chapter IV: Inspections

Chapter V: Additional Information

Chapter VI: Legislation


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