EudraLex – Hacim 10 Klinik araştırmalar yönergeleri

Hacim 10 yayınların “Avrupa Birliği'nde tıbbi ürünlere ilişkin kurallar” klinik araştırmalara uygulanan kılavuz belgeleri içerir.

Bölüm 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)
  • Ek 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. (Haziran 2011)

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

• Good manufacturing practices for manufacture of investigational medicinal products [67 KB] (Şubat 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 (Temmuz 2006)
• • GCP denetimleri ve bulgularına ilişkin iletişim kılavuzu
  • EudraCT'de GCP denetim girişlerinin standartlaştırılmasına yönelik prosedür
  • İyi Klinik Uygulamaları denetim raporlarının hazırlanmasına ilişkin kılavuz
  • Klinik araştırmalarda İyi Klinik Uygulamaları hükümlerine uygunluğu doğrulayan denetçilerin niteliklerine ilişkin tavsiyeler
• 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 (Mart 2010)
• Annex VII to Guidance for the conduct of GCP inspections – Biyoanalitik kısım, Pharmacokinetic and Statistical Analyses of Bioequivalence Trials
• GCP denetimlerinin koordinasyonu ve GCP denetçileri arasındaki işbirliğine ilişkin kılavuz, referans ve ilgili Üye Devletler ve CMD(H) , Karşılıklı tanınma ve merkezi olmayan prosedürler için pazarlama izni başvurularının GSO uyumluluğunun değerlendirilmesi bağlamında
• Maddeye Göre GCP Denetim Raporlarının Değişimi Rehberi 15(2) 2001/20/EC Direktifi (revision 1 – Mayıs 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: İyi Klinik Uygulamaları: Consolidated guideline, CPMP/ICH/135/95)
• Detailed guidelines on good clinical practice specific to advanced therapy medicinal products (Aralık 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 (AK) HAYIR 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 (AK) HAYIR 1901/2006
  • List of fields to be made public from EudraCT for Paediatric Clinical Trials in accordance with Article 41 of Regulation (AK) HAYIR 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)
• “Sorular & Answers” Document – Sürüm 8 (Mart 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: Mevzuat

• Commission Directive 2005/28/EC of 8 Nisan 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 Ekim 2003 Beşeri tıbbi ürünler ve beşeri tıbbi araştırma ürünlerine ilişkin iyi üretim uygulamalarına ilişkin ilke ve esasların belirlenmesi (Official Journal L 262, 14/10/2003 P. 22 – 26).

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