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

• Detailed guidance on the application format and documentation to be submitted in an application for an Ethics Committee opinion on the clinical trial on medicinal products for human use [135 KB] (revision 1 of February 2006)
• Detailed guidance on the European clinical trials database (EUDRACT Database) [230 KB] (revision of April 2004)

• Detailed guidance for the request for authorisation of a clinical trial on a medicinal product for human use to the competent authorities, notification of substantial amendments and declaration of the end of the trial [1022 KB] Translations. (revision 3 of March 2010)
• • • substantial Amendment Notification Form : PDF version (revision 3 of June 2010)
    • Declaration of the End of Trial Form : PDF version (revision 3 of June 2010)
  • Annexe 1 revised Pdf version [86 KB] (revision 4 of November 2009) – EudraCT Version 8.0 uses the Revision 4 dated November 2009 of the Clinical Trials Application Form. For more information please refer to the EudraCT website

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. (Juin 2011)

ICH guideline E2F – Note for guidance on development safety update reports (Septembre 2010)
To give additional support, ICH has established ‘model DSURs’ which are accessible ici. 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

• Guideline on the requirements to the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials [140 KB]
• Guidance on Investigational Medicinal Products (IMPs) et ‘non investigational medicinal products’ (NIMPs) [48 KB] (rev. 1, Mars 2011)

• Good manufacturing practices for manufacture of investigational medicinal products [67 KB] (Février 2010)Community basic format for manufacturing authorisation / Community basic format for manufacturers / importers

Chapter IV: Inspections

• Conseils pour la préparation des inspections BPC
• Recommandation sur les procédures d'inspection pour la vérification du respect des bonnes pratiques cliniques (Juillet 2006)
• • Orientations pour la communication sur les inspections et les conclusions des BPC
  • Procédure de normalisation des entrées d'inspection BPC dans EudraCT
  • Guide pour la préparation des rapports d’inspection des bonnes pratiques cliniques
  • Recommandations sur les qualifications des inspecteurs vérifiant le respect, lors des essais cliniques, des dispositions des Bonnes Pratiques Cliniques
• Annexe V aux lignes directrices pour la conduite des inspections BPC – Unités de phase I
• Annexe VI du Guide pour la conduite des inspections BPC – Tenue de registres et archivage des documents (Mars 2010)
• Annexe VII du Guide pour la conduite des inspections BPC – Partie bioanalytique, Analyses pharmacocinétiques et statistiques des essais de bioéquivalence
• Orientations pour la coordination des inspections GCP et la coopération entre les inspecteurs GCP, la référence et les États membres concernés et CMD(h) , dans le cadre de l’évaluation de la conformité aux BPC des demandes d’autorisation de mise sur le marché pour les procédures de reconnaissance mutuelle et décentralisées
• Orientations pour l'échange de rapports d'inspection GCP conformément à l'article 15(2) de la directive 2001/20/CE (revision 1 – Peut 2009)
• • Orientations pour la conduite des inspections BPC
  • Annexe I du Guide pour la conduite des inspections BPC – investigator site
  • Annexe II aux lignes directrices pour la conduite de l'inspection BPC – laboratoires cliniques
  • Annexe III aux lignes directrices pour la conduite des inspections BPC – systèmes informatiques
  • Annexe IV aux lignes directrices pour la conduite des inspections BPC – Sponsor et CRO

Chapter V: Additional Information

• Guidelines on good clinical practice (ICH E6: Bonnes pratiques cliniques: Consolidated guideline, CPMP/ICH/135/95)
• Detailed guidelines on good clinical practice specific to advanced therapy medicinal products (Décembre 2009)
• Recommendation on the content of the trial master file and archiving
• • List of fields contained in the ‘EudraCT’ clinical trials database to be made public, in accordance with Article 57(2) of Regulation (CE) Non 726/2004 and its implementing guideline 2008/C168/02
  • Guideline 2009/C28/01 on the information concerning paediatric clinical trials to be entered into the EU Database on Clinical Trials (EudraCT) and on the information to be made public by the European Medicines Agency (EMEA), in accordance with Article 41 of Regulation (CE) Non 1901/2006
  • List of fields to be made public from EudraCT for Paediatric Clinical Trials in accordance with Article 41 of Regulation (CE) Non 1901/2006 and its implementing guideline 2009/C28/01
  • EudraCT – List of additional fields contained in EudraCT (reasons for negative opinions of the Ethics Committee)
• « Des questions & Answers » Document – Version 8 (Mars 2011)
• Ethical considerations for clinical trials on medicinal products conducted with the paediatric population
• Guideline 2008/C168/02 on the data fields from the European clinical trials database (EudraCT) that may be included in the European database on Medicinal Products

Chapter VI: Legislation

• Commission Directive 2005/28/EC of 8 Avril 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products.
• Commission Directive 2003/94/EC of 8 Octobre 2003 établissant les principes et lignes directrices des bonnes pratiques de fabrication des médicaments à usage humain et des médicaments expérimentaux à usage humain (Official Journal L 262, 14/10/2003 p. 22 – 26).

• Directive 2001/20/EC OF the European Parliament and of the Council of 4 Avril 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use.