EudraLex – Volumen 10 Clinical trials guidelines

Volumen 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)
  • Annex 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. (Junio 2011)

ICH guideline E2F – Note for guidance on development safety update reports (Septiembre 2010)
To give additional support, ICH has established ‘model DSURs’ which are accessible aquí. 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) and ‘non investigational medicinal products’ (NIMPs) [48 KB] (rev. 1, Marzo 2011)

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

Chapter IV: Inspections

• Orientación para la preparación de inspecciones de BPC
• Recomendación sobre procedimientos de inspección para la verificación del cumplimiento de las buenas prácticas clínicas (Julio 2006)
• • Guía para la comunicación sobre inspecciones y hallazgos de BPC
  • Procedimiento para la estandarización de entradas de inspección BPC en EudraCT
  • Guía para la elaboración de informes de inspección de Buenas Prácticas Clínicas
  • Recomendaciones sobre la cualificación de los inspectores que verifican el cumplimiento en los ensayos clínicos de lo dispuesto en las Buenas Prácticas Clínicas
• Anexo V de la Guía para la realización de inspecciones de BPC – Unidades Fase I
• Anexo VI de la Guía para la realización de inspecciones de BPC – Mantenimiento de registros y archivo de documentos. (Marzo 2010)
• Anexo VII de la Guía para la realización de inspecciones de BPC – Parte bioanalítica, Análisis farmacocinéticos y estadísticos de ensayos de bioequivalencia
• Orientación para la coordinación de las inspecciones de BPC y la cooperación entre inspectores de BPC, los Estados miembros de referencia y afectados y el CMD(h) , en el contexto de la evaluación del cumplimiento de las BPC de las solicitudes de autorización de comercialización para el reconocimiento mutuo y los procedimientos descentralizados
• Orientación para el intercambio de informes de inspección de BPC según el artículo 15(2) de la Directiva 2001/20/CE (revision 1 – Puede 2009)
• • Guía para la realización de inspecciones de BPC
  • Anexo I de la Guía para la realización de inspecciones de BPC – investigator site
  • Anexo II de la Guía para la realización de inspecciones de BPC – laboratorios clínicos
  • Anexo III de la Guía para la realización de inspecciones de BPC – sistemas informáticos
  • Anexo IV de la Guía para la realización de inspecciones de BPC – Patrocinador y CRO

Chapter V: Additional Information

• Guidelines on good clinical practice (ICH E6: Buena práctica clínica: Consolidated guideline, CPMP/ICH/135/95)
• Detailed guidelines on good clinical practice specific to advanced therapy medicinal products (Diciembre 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 (EC) No 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 (EC) No 1901/2006
  • List of fields to be made public from EudraCT for Paediatric Clinical Trials in accordance with Article 41 of Regulation (EC) No 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)
• “Preguntas & Answers” Document – Version 8 (Marzo 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 Abril 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 Octubre 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use (Official Journal L 262, 14/10/2003 p. 22 – 26).

• Directive 2001/20/EC OF the European Parliament and of the Council of 4 Abril 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.