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)
  • 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. (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

• 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, March 2011)

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

Chapter IV: Inspections

• Guidance for the preparation of GCP inspections
• Recommendation on inspection procedures for the verification of good clinical practice compliance  (July 2006)
• • Guidance for the communication on GCP inspections and findings
  • Procedure for standardisation of GCP inspection entries in EudraCT
  • Guidance for the preparation of Good Clinical Practice inspection reports
  • Recommendations on the qualifications of inspectors verifying compliance in clinical trials with the provisions of Good Clinical Practice
• Annex V to Guidance for the conduct of GCP inspections – Phase I Units
• Annex VI to Guidance for the conduct of GCP inspections – Record keeping and archiving of documents  (March 2010)
• Annex VII to Guidance for the conduct of GCP inspections – Bioanalytical part, Pharmacokinetic and Statistical Analyses of Bioequivalence Trials
• Guidance for coordination of GCP inspections and co-operation between GCP inspectors, the reference and concerned Member States and CMD(h) , in the context of the evaluation of the GCP compliance of marketing authorization applications for mutual recognition and decentralized procedures
• Guidance for exchange of GCP Inspection Reports according to Article 15(2) of Directive 2001/20/EC  (revision 1 – May 2009)
• • Guidance for the conduct of GCP inspections
  • Annex I to Guidance for the conduct of GCP inspections – investigator site
  • Annex II to Guidance for the conduct of GCP inspection – clinical laboratories
  • Annex III to Guidance for the conduct of GCP inspections – computer systems
  • Annex IV to Guidance for the conduct of GCP inspections – Sponsor and CRO

Chapter V: Additional Information

• Guidelines on good clinical practice (ICH E6: Good Clinical Practice: Consolidated guideline, CPMP/ICH/135/95)
• Detailed guidelines on good clinical practice specific to advanced therapy medicinal products  (December 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)
• “Questions & Answers” Document – Version 8 (March 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 April 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 October 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 April 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.

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