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Crohn's disease

Crohn's disease is an ongoing condition that causes inflammation of the digestive tract, or the GI (gastrointestinal) tract (the gut).
Italy
Legislations
  1. Statute on the National Federation of Ethics Committees (1995) (Italian)
  2. Legislative Decree 200, 6 November 2007: Implementation of Directive 2005/28/EC laying down principles and detailed guidelines for good clinical practice relating to medicinal products for human use, and requirements for authorization of the manufacture or importation of such products
  3. Legislative Decree 211, 24 June 2003: Implementation of Directive 2001/20/EC relating to the implementation of good clinical practice in clinical trials of medicines for clinical use
  4. Decree of the President of the Istituto Superiore di Sanita, 26 April 2002: Determination of the composition and safety of drugs before the new institution clinical trials on humans. Identification of the documentation to be submitted to the top of health in accordance with art. 4, paragraph 2 of the Decree of the President of the Republic 21 September 2001, No 439
  5. Presidential Decree No. 439 of 21 September 2001: Rules to simplify procedures for the verification and monitoring of new and experimental treatment protocols
  6. Presidential Decree 14 January 1997: Adoption of the guidance and coordination to regions and autonomous provinces of Trento and Bolzano, in the field of structural, technological and organizational minimum for the pursuit of health by the public and private
  7. Italian Personal Data Protection Code, Legislative Decree No. 196 of June 30, 2003
 
Regulations
  1. FNACE: Regulation Implementing the Statute on the National Federal of Ethics Committees (1995)
  2. OSS: Ministerial Decree: Terms of Reference for the Establishment and the Functioning of Ethics Committees (May 12, 2006)
  3. AIFA determination of 23 December 2008: Minimum of self-organization of contract research (CRO) in clinical trials of medicines in accordance with Article 7, paragraphs 5 and 6 and Article 8 of the Ministerial Decree 31 March 2008
  4. Ministerial decree of 7 November 2008: Changes and additions to Decree 19 March 1998 on "Recognition of fitness centers for clinical trials of medicines', 8 May 2003 on" therapeutic use of medicinal products undergoing clinical trials and 12 May 2006 laying down requirements for minimum 'institution, organization and functioning of ethics committees for clinical trials of medicines'
  5. Ministerial decree of 31 March 2008: Definition of minimum requirements for organizations to contract research (CRO) in clinical trials of medicines
  6. Explanatory Circular DM 31 March 2008: Questions and Answers relating to the Ministerial Decree of 31 March 2008 "Establishment of minimum requirements for CRO in clinical trials of medicines" (AIFAII/11029/PI.9.ab/85 - Rome, February 4 2009)
  7. Errata-corrige AIFA Determination to 20 March 2008: Communiqué on the determination 20 March 2008 dell'AIFA on: "Guidelines for the Classification and conduct of observational studies on drugs'
  8. Determination AIFA March 20 2008: Guidelines for classification and conduct of observational studies on drugs
  9. Ministerial Decree 21 December 2007: Manner of forwarding the request for authorization to the competent authority, for the provision of substantial amendments and declaration of termination of the clinical trial and the request for opinion to the ethics committee
  10. Ministerial Decree 12 May 2006: Minimum requirements for the establishment, organization and functioning of ethics committees for clinical trials of medicines
  11. Ministerial Decree 17 December 2004: Requirements and general conditions relating to implementation of clinical trials of medicines, with particular reference to those for the improvement of clinical practice as an integral part of health care
  12. Ministerial Decree 8 May 2003: Therapeutic use of medicines undergoing clinical trials
  13. Ministerial Circular No 6, 2 September 2002: Activities of ethics committees established under the Ministerial Decree 18 March 1998
  14. Ministerial Decree of 30 May 2001: Inspection findings on compliance with the standards of good clinical practice
  15. Ministerial Decree of 10 May 2001: Controlled clinical trials in general medicine and pediatrics of free choice
  16. Ministerial Decree of 28 December 2000: Measures aimed at minimizing the risk of transmission to humans through drugs, agents causing animal spongiform encephalopathy
  17. Dirigenziale decree of 25 May 2000: By electronic transmission of data concerning clinical trials of medicines
  18. Ministerial Decree of 23 November 1999:  Determining the composition and functions of the National Ethics Committee for clinical trials of medicinal products, pursuant to Legislative Decree No 229, 19 June 1999
  19. Ministerial Circular No 16 of 12 October 1999: Irregularities in the authorization procedures and execution of clinical trials of medicines
  20. Ministerial Decree of 13 May 1999: Additions to the Ministerial Decree 18 March 1998: "Methods for exemption from the findings on medicines used in clinical trials" and the Ministerial Decree 19 March 1998: "Recognition of fitness centers for clinical trials of medicines
  21. Ministerial Circular No 6 of 8 April 1999: Clarifications on DD.MM. 18 March 1998 and 19 March 1998 published in OJ No 123, 28 May 1998
  22. Ministerial Decree of 20 January 1999: Measures on the marketing and clinical trials of medicinal products containing materials of bovine origin
  23. Ministerial Decree of 7 October 1998: D.M. 7 October 1998, laying out in the Decree integrations March 19, 1998 "Recognition of fitness centers for clinical trials of medicines" (published in OJ No 274 of 23 November 1998)
  24. Ministerial Decree of 15 September 1998: D.M. 15 September 1998 amending Decree 18 March 1998 "mode for exemption from the findings on medicines used in clinical trials"
  25. Ministerial Decree of 19 March 1998: D.M. concerning the criteria for the recognition of fitness centers for clinical trials of medicines
  26. Ministerial Decree of 18 March 1998: Ministerial Decree 18 March 1998 laying down the procedures for exemption from the findings, under Presidential Decree No. 754 of 21 September 1994, on medicines used in clinical trials (published in OJ No 122 of 28 May 1998)
  27. Ministerial Decree of 22 December 1997: Residual charges referred to Ministerial Decree 19 July 1993 on charges and fees payable to the Ministry of Health, at the top of health and at the top for the prevention and safety at work, for services rendered at the request of the utility and stakeholders
  28. Ministerial Decree of 15 July 1997: Implementation of guidelines U. E. Good Clinical Practice for the conduct of clinical trials of medicines
  29. Ministerial Decree of 4 December 1990: Modifications to D.M. 23 June 1981 regulating the activity of scientific information on medicines
  30. Administrative Decree: Electronic Data Transmission Pertaining to Clinical Medical Experimentation (May 25, 2000)
 
Guidelines
  1. NBC: Opinion of the National Bioethics Committee on the European Protocol on Biomedical Research (1999)
  		 


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