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Prototype devices

It is recognized that a manufacturer may wish to submit a small number  of "prototype models" of a device to clinical investigation in order to assess safety and/or performance; and those such prototypes may need to undergo a number of changes prior to large-scale production.
International

Guidelines

OHCHR:

  • International Covenant on Civil and Political Rights, Article 7 (1976)


CIOMS:

  • International Guidelines for Ethical Review of Epidemiological Studies (1991)
  • International Ethical Guidelines for Biomedical Research Involving Human Subjects (2002)
  • International Ethical Guidelines for Biomedical Research Involving Human Subjects (An Islamic Perspective) (2004)


UNAIDS:

  • Ethical Considerations in HIV Preventive Vaccine Research (2000)


WMA:

  • Declaration of Helsinki (2008)
  • Declaration on Ethical Considerations Regarding Health Databases (2002)


UNESCO:

  • Universal Declaration on Bioethics and Human Rights (2005)


WHO:

  • Operational Guidelines for Ethics Committees that Review Biomedical Research (2000)
  • Handbook for Good Clinical Research Practice (GCP): Guidance for Implementation (2002)
  • Operational Guidance: Information Needed to Support Clinical Trials of Herbal Products (2005)


ICH:

  • E6 (R1) Good Clinical Practice: Consolidated Guidance (1996)


     

     
  		 


Opinion Poll

Which one of the following do you think is the most common reason for participating in clinical trials?
 
This opinion poll provides an informal way for the clinical research community to express its views on current topics. The results are not a scientific poll and do not necessarily reflect the percentages of all clinical researchers who agree with these positions.
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