8. Good clinical practice

go back to reference Council of Europe European Treaty Series (ETS) 164: Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine. Oviedo, 4. April.1997. Including: Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Biomedical Research. Strasbourg, 25 Jan 2005. including: Explanatory Report on the Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine. Council of Europe European Treaty Series (ETS) 164: Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine. Oviedo, 4. April.1997. Including: Additional Protocol to the Convention on Human Rights and Biomedicine, concerning Biomedical Research. Strasbourg, 25 Jan 2005. including: Explanatory Report on the Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine.

go back to reference Directive 90/385/EEC of 14 July 1990 of the European Parliament and of the Council on the approximation of the laws of the Member States relating to active implantable medical devices. OJ L189, 20 Jul 1990, 17–36. Directive 90/385/EEC of 14 July 1990 of the European Parliament and of the Council on the approximation of the laws of the Member States relating to active implantable medical devices. OJ L189, 20 Jul 1990, 17–36.

go back to reference Directive 93/42/EEC of 14 July 1993 concerning medical devices. OJ L169, 12 Jul 1993, 1–43. Directive 93/42/EEC of 14 July 1993 concerning medical devices. OJ L169, 12 Jul 1993, 1–43.

go back to reference Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data. OJ L 281 23 Nov 1995. The Directive is under review by the European Commission. Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the protection of individuals with regard to the processing of personal data and on the free movement of such data. OJ L 281 23 Nov 1995. The Directive is under review by the European Commission.

go back to reference Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices. OJ L 331, 07 Dec 1998, 1–37. Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices. OJ L 331, 07 Dec 1998, 1–37.

go back to reference Directive 2001/20/EC of 4 April 2001 on the approximation of rules, regulations and administrative provisions of member states relating to implementation of good clinical practices in conducting clinical trials on medicinal products for human use. OJ L121 1 May 2001, 33–44. Directive 2001/20/EC of 4 April 2001 on the approximation of rules, regulations and administrative provisions of member states relating to implementation of good clinical practices in conducting clinical trials on medicinal products for human use. OJ L121 1 May 2001, 33–44.

go back to reference Global harmonisation task force for medical devices: SG1 N41 R19 Essential principles of safety and performance of medical devices 20 May 2005. Global harmonisation task force for medical devices: SG1 N41 R19 Essential principles of safety and performance of medical devices 20 May 2005.

go back to reference International Committee for Harmonisation for the Pharmaceutical Industry: ICH Harmonised Tripartite Guideline for Good Clinical Practices. CPMP/IEC/135/95. Incorporated in the EU as Directive 2001/20/EC. International Committee for Harmonisation for the Pharmaceutical Industry: ICH Harmonised Tripartite Guideline for Good Clinical Practices. CPMP/IEC/135/95. Incorporated in the EU as Directive 2001/20/EC.

go back to reference International Committee for Harmonisation for the Pharmaceutical Industry: ICH Topic E9 Statistical Principles for Clinical Trials. Accepted by the European Medicines Evaluation Agency (EMEA) Committee for Proprietary Human Medicines (CPMP) and published as: Note for guidance on statistical principals for clinical trials CPMP/ICH/363/96 March 1998. International Committee for Harmonisation for the Pharmaceutical Industry: ICH Topic E9 Statistical Principles for Clinical Trials. Accepted by the European Medicines Evaluation Agency (EMEA) Committee for Proprietary Human Medicines (CPMP) and published as: Note for guidance on statistical principals for clinical trials CPMP/ICH/363/96 March 1998.

go back to reference International Standards organisation (ISO) 13485:2003: Medical devices - Quality management systems: Requirements for regulatory purposes. International Standards organisation (ISO) 13485:2003: Medical devices - Quality management systems: Requirements for regulatory purposes.

go back to reference International Standards organisation (ISO) ISO 14155.1:2011: Clinical investigation of medical devices for human subjects – Part 1: general requirements. International Standards organisation (ISO) ISO 14155.1:2011: Clinical investigation of medical devices for human subjects – Part 1: general requirements.

go back to reference International Standards organisation (ISO) ISO 14155.2:2011:Clinical investigation of medical devices for human subjects - Part 2: clinical investigation plans. International Standards organisation (ISO) ISO 14155.2:2011:Clinical investigation of medical devices for human subjects - Part 2: clinical investigation plans.

go back to reference Jong MG de, Pieterse H. State of the art clinical trials for medical devices: a guide to Good Clinical Practices compliance. Wijk bij Duurstede, Netherlands: Medidas. August 2007. Jong MG de, Pieterse H. State of the art clinical trials for medical devices: a guide to Good Clinical Practices compliance. Wijk bij Duurstede, Netherlands: Medidas. August 2007.

go back to reference Medical Device Guidance: MEDDEV 2.1/3 rev3: Guidelines relating to the application of Council Directive 90/385/EEC on active implantable medical devices and Council Directive 93/42/EEC on medical devices: demarcation between [medical device directives] and [directives] on medicinal products and related directives. December 2009. Medical Device Guidance: MEDDEV 2.1/3 rev3: Guidelines relating to the application of Council Directive 90/385/EEC on active implantable medical devices and Council Directive 93/42/EEC on medical devices: demarcation between [medical device directives] and [directives] on medicinal products and related directives. December 2009.

go back to reference Medical Device Guidance: MEDDEV 2.4/1 rev 9: Guidelines for classification of medical devices. June 2010. Medical Device Guidance: MEDDEV 2.4/1 rev 9: Guidelines for classification of medical devices. June 2010.

go back to reference Medical device guidance: MEDDEV 2.7/1 Guidance on clinical evidence. December 2009. Medical device guidance: MEDDEV 2.7/1 Guidance on clinical evidence. December 2009.

go back to reference Medical device guidance: MEDDEV 2.12/1 rev. 8 Medical device vigilance. January 2013. Medical device guidance: MEDDEV 2.12/1 rev. 8 Medical device vigilance. January 2013.

go back to reference Medical device guidance: MEDDEV 2.12/2 Guidelines on post-market clinical follow up. January 2012. Medical device guidance: MEDDEV 2.12/2 Guidelines on post-market clinical follow up. January 2012.

go back to reference Pieterse H, Jong MG de. The changing regulatory environment for the clinical evaluation of medical devices in Europe. Regulatory Affairs Journal Devices, 2005; 13:355–62. Pieterse H, Jong MG de. The changing regulatory environment for the clinical evaluation of medical devices in Europe. Regulatory Affairs Journal Devices, 2005; 13:355–62.

go back to reference Pieterse H, Jong MG de, et al. Clinical trials for medical devices. New York: Interpharm/T&F Press. Pieterse H, Jong MG de, et al. Clinical trials for medical devices. New York: Interpharm/T&F Press.

go back to reference Pieterse H, Jong MG de. Een degelijke klinische ontwikkeling van medische hulpmiddelen is een vereiste om de continuïteit van zorg te garanderen. Nederlands Tijdschrift voor Medische Administratie, 2006; 124:10–17. Pieterse H, Jong MG de. Een degelijke klinische ontwikkeling van medische hulpmiddelen is een vereiste om de continuïteit van zorg te garanderen. Nederlands Tijdschrift voor Medische Administratie, 2006; 124:10–17.

go back to reference Pieterse H, Jong MG de. The essentials of Good Regulatory Compliance. Regulatory Affairs Journal Devices, 2006; 14:293–8. Pieterse H, Jong MG de. The essentials of Good Regulatory Compliance. Regulatory Affairs Journal Devices, 2006; 14:293–8.

go back to reference Pieterse H, Jong MG de. Essentials of Good Regulatory Compliance: The REACT Principles. Wijk bij Duurstede, Netherlands: Medidas. Pieterse H, Jong MG de. Essentials of Good Regulatory Compliance: The REACT Principles. Wijk bij Duurstede, Netherlands: Medidas.

go back to reference Pieterse H, Jong MG de. Proper clinical development of medical devices to ensure continuity of care. Health Information Developments in the Netherlands, 2006; 8:51–5. Pieterse H, Jong MG de. Proper clinical development of medical devices to ensure continuity of care. Health Information Developments in the Netherlands, 2006; 8:51–5.

go back to reference Pieterse H, Jong MG de. A Vision for EU Device Regulation. Regulatory Affairs Journal Devices, 2007; 15: 81–6. Pieterse H, Jong MG de. A Vision for EU Device Regulation. Regulatory Affairs Journal Devices, 2007; 15: 81–6.

go back to reference Pieterse H. Clinical Trials with medical devices. Regulatory Affairs Journal Devices, 1994; 5:109 -12. Pieterse H. Clinical Trials with medical devices. Regulatory Affairs Journal Devices, 1994; 5:109 -12.

go back to reference Pieterse H. Clinical Trial Requirements in the Netherlands. European Pharma Law Centre Reports (SCRIP Report) 1994;6:4–10. Pieterse H. Clinical Trial Requirements in the Netherlands. European Pharma Law Centre Reports (SCRIP Report) 1994;6:4–10.

go back to reference Pieterse H. EN-540 flowchart of clinical Investigations with medical devices. Regulatory Affairs Journal Devices, 1994; 8:276. Pieterse H. EN-540 flowchart of clinical Investigations with medical devices. Regulatory Affairs Journal Devices, 1994; 8:276.

go back to reference Pieterse H. Product Registration in the Netherlands. European Pharma Law Centre Reports (SCRIP Report) 1994; 11: 9–20. Pieterse H. Product Registration in the Netherlands. European Pharma Law Centre Reports (SCRIP Report) 1994; 11: 9–20.

go back to reference Pieterse H, Franssen G, Floor M, et al. Source Documents: Definitions, Verification Procedure, and Archiving. Applied Clinical Trials, 1994; 3:38–45. Pieterse H, Franssen G, Floor M, et al. Source Documents: Definitions, Verification Procedure, and Archiving. Applied Clinical Trials, 1994; 3:38–45.

go back to reference Pieterse H. Archiving Source Documents in compliance with GCP and Dutch Laws. GCP Journal. 1995; 2: 10–13. Pieterse H. Archiving Source Documents in compliance with GCP and Dutch Laws. GCP Journal. 1995; 2: 10–13.

go back to reference Pieterse H. How to write a Clinical Investigator Brochure for clinical trials with medical devices. Regulatory Affairs Journal Devices, 1995; 11:292–6. Pieterse H. How to write a Clinical Investigator Brochure for clinical trials with medical devices. Regulatory Affairs Journal Devices, 1995; 11:292–6.

go back to reference Pieterse H. Elektronische Patiëntendossiers: Van fictie naar werkelijkheid. Conceptuur. 1996; 9:24–5. Pieterse H. Elektronische Patiëntendossiers: Van fictie naar werkelijkheid. Conceptuur. 1996; 9:24–5.

go back to reference Pieterse H. The Future of Computerisation at the Investigator Site. Applied Clinical Trials, 1996; 5:32–40. Pieterse H. The Future of Computerisation at the Investigator Site. Applied Clinical Trials, 1996; 5:32–40.

go back to reference Pieterse H. Common Sense Guideline for Clinical Trials in the Netherlands. Heerhugowaard, Netherlands: Profess Medical Consultancy B.V., 1999. Pieterse H. Common Sense Guideline for Clinical Trials in the Netherlands. Heerhugowaard, Netherlands: Profess Medical Consultancy B.V., 1999.

go back to reference Pieterse H. Gezond Boerenverstand Richtlijn voor klinisch onderzoek – betreffende het uitvoeren van medisch-wetenschappelijk onderzoek in Nederland. Heerhugowaard, Netherlands: Profess Medical Consultancy B.V., 1999. Pieterse H. Gezond Boerenverstand Richtlijn voor klinisch onderzoek – betreffende het uitvoeren van medisch-wetenschappelijk onderzoek in Nederland. Heerhugowaard, Netherlands: Profess Medical Consultancy B.V., 1999.

go back to reference Pieterse H. The Netherlands. In: International Clinical Trials - A guidebook and Compendium of National Drug Laws. Brunier D, Nahler G(eds), 1999: Interpharm Press Inc. Vol 2: 17–56. Pieterse H. The Netherlands. In: International Clinical Trials - A guidebook and Compendium of National Drug Laws. Brunier D, Nahler G(eds), 1999: Interpharm Press Inc. Vol 2: 17–56.

go back to reference Pieterse H, Jong MG de, Duijst P. (eds) Clinical Regulatory Environment. In; International Medical Device Clinical Investigations -a practical approach. New York: Interpharm Press Inc, 1999. Pieterse H, Jong MG de, Duijst P. (eds) Clinical Regulatory Environment. In; International Medical Device Clinical Investigations -a practical approach. New York: Interpharm Press Inc, 1999.

go back to reference SOMO briefing paper on ethics in clinical trials: Examples of unethical trials. November 2006. SOMO briefing paper on ethics in clinical trials: Examples of unethical trials. November 2006.

go back to reference World Medical Association: Declaration of Helsinki. Adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964; last amended October 2013, Fortaleza, Brazil. World Medical Association: Declaration of Helsinki. Adopted by the 18th WMA General Assembly, Helsinki, Finland, June 1964; last amended October 2013, Fortaleza, Brazil.

go back to reference World Medical Association: International Code of Medical Ethics Adopted by the 3rd General Assembly of the World Medical Association, London, England, October 1949. last amended South Africa, 2006. World Medical Association: International Code of Medical Ethics Adopted by the 3rd General Assembly of the World Medical Association, London, England, October 1949. last amended South Africa, 2006.