General
Program for DIA Electronic Document Management conference, 1-3 December 2010, Nice, France - download
Clinical Trial Resources
| Scope | Issued | Title | Download |
| ICH | 1996 | ICH Topic E6 Guidlines for Good Clinical Practice. Note for guidance on good clinical practice (CPMP/ICH/135/95) | Download |
| UK | 1998 | MRC Guidelines for Good Clinical Practice in Clinical Trials | Download |
| EU | 2001 | Directive 2001/20/EC 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 [the GCP Directive] | Download |
| EU | 2001 | Directive 2001/83/EC on the Community code relating to medicinal products for human use [the Clinical Trials Directive] | Download |
| EU | 2003 | Directive 2003/63/EC amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use. Annex 1 | Download |
| US | 2005 | Electronic Clinical Data Capture (EDC): Position Paper. Clinical Trial EDC Task Group, PhRMA Biostatistics and data Management Technical Group | Download |
| EU | 2005 | Directive 2005/28/EC 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 | Download |
| UK | 2006 | Statutory Instrument 2006 No. 1928. The Medicines for Human Use (Clinical Trials) Amendment Regulations 2006 | Download |
| EU | 2006 | Rules Governing Medicinal Products in the European Union Volume 10: Clinical Trials - Notice to applicants. Chapter 5: Recommendation on the content of the trial master file and archiving | Download |
| Investigational medicinal product: |
| EU | 2003 | Rules Governing Medicinal Products in the European Union Volume 4: Good manufacturing practices. Annex 13: manufacture of investigational medicinal products | Download |
| EU | 2005 | 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 | Download |
| EU | 2006 | Guideline on the requirements to the chemical and pharmaceutical quality documentation concerning investigational medicinal products in clinical trials | Download |