EudraLex - Volume 10 Clinical trials guidelines

Chapter I : Application and Application Form

- General information ( - 375kb) (July 2006)

- 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 ( - 333kb) (revision 2 of October 2005)

* Annex 1 : "Clinical trial application form" - ( - 225kb) (revision 2 of October 2005)

Annex 1 revised ( - 83kb) (revision 3 of June 2009)

Please note : Recent changes in the regulatory framework for pharmaceuticals and clinical trials in the EU (mainly consequences of the paediatrics legislation and the legislation on advanced therapies) have required changes to the clinical trials application form. This is the revised version of the clinical trials application form. It will become applicable in the course of Q4 2009, and is published in advance to allow stakeholders time for preparation. A precise date for applicability is going to be published by the Commission and EMEA in due course and will coincide with the launch into production of Version 8 of EudraCT.

* Annex 2 : "Substantial Amendment Form" ( - 136kb) - (revision 2 of October 2005)

* Annex 3 : "Declaration of the end of the trial" ( - 104kb) - (revision 2 of October 2005)

- 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 ( - 134kb) (revision 1 of February 2006)

- Detailed guidance on the European clinical trials database (EUDRACT Database) ( - 230kb) (revision of April 2004)

Chapter II : Monitoring and Pharmacovigilance

- Detailed guidance on the collection, verification and presentation of adverse reaction reports arising from clinical trials on medicinal products for human use ( - 87kb) (revision 2 of April 2006)

- Detailed guidance on the European database of Suspected Unexpected Serious Adverse Reactions (Eudravigilance Clinical Trial Module) ( - 114kb) (revision 1 of April 2004)

Chapter III : Quality of the Investigational Medicinal Product

- Good manufacturing practices for manufacture of investigational medicinal products ( - 259kb) (July 2003)

- Community basic format for manufacturing authorisation / Community basic format for manufacturers / importers

- Guideline on the requirements to the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials ( - 139kb)

- Guidance on Investigational Medicinal Products (IMPs) and other medicinal products used in Clinical Trials ( - 40kb)

Chapter IV : Inspections

* Guidance for the preparation of GCP inspections ( - 45kb) (June 2008)

* Recommendation on inspection procedures for the verification of good clinical practice compliance ( - 170kb) (July 2006)

* Guidance for the conduct of GCP inspections ( - 26kb) (June 2008)

o Annex I to Guidance for the conduct of GCP inspections - investigator site ( - 45kb) (June 2008)
o Annex II to Guidance for the conduct of GCP inspection - clinical laboratories ( - 38kb) (June 2008)
o Annex III to Guidance for the conduct of GCP inspections - computer systems ( - 12kb) (June 2008)
o Annex IV to Guidance for the conduct of GCP inspections - Sponsor and CRO ( - 42kb) (June 2008)
o Annex V to Guidance for the conduct of GCP inspections - Phase I Units ( - 34kb) (November 2008)
o Annex VII to Guidance for the conduct of GCP inspections - Bioanalytical part, Pharmacokinetic and Statistical Analyses of Bioequivalence Trials ( - 37kb) (November 2008)

* 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 ( - 65kb) (June 2009)

*Guidance for exchange of GCP Inspection Reports according to Article 15(2) of Directive 2001/20/EC ( - 27kb)(revision 1 - May 2009)

* Guidance for the communication on GCP inspections and findings ( - 22kb) (June 2008)

* Procedure for standardisation of GCP inspection entries in EudraCT ( - 32kb) (November 2008)

* Guidance for the preparation of Good Clinical Practice inspection reports ( - 29kb) (June 2008)

* Recommendations on the qualifications of inspectors verifying compliance in clinical trials with the provisions of Good Clinical Practice ( - 124kb) (July 2006)

Chapter V : Additional Information

- Guidelines on good clinical practice (ICH E6: Good Clinical Practice: Consolidated guideline, CPMP/ICH/135/95) ( - 215kb) (1996)

- Recommendation on the content of the trial master file and archiving ( - 279kb) (July 2006)

-"Questions & Answers" Document - Version 4 ( - 74kb)(July 2009)

- Ethical considerations for clinical trials on medicinal products conducted with the paediatric population ( - 233kb) (2008)

- 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 ( - 52kb) (July 2008)

- 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 ( - 97kb) (February 2009)

- 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 ( - 71kb) (February 2009)

- 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 ( - 99kb) (February 2009)

Chapter VI : Legislation

- 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. ( - 152kb)

- 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. ( - 66kb)

- 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).