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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.

Legislations, Regulations and Guidelines

This list of Legislations, Regulations and Guidelines govern human subjects research and clinical research as well as standards from international and regional organizations. This is useful for IRBs/IECs, Clinical Research Professionals and others who are involved in international research in order to familiarize with the applicable laws, regulations, and guidelines. This information includes General (applicable to most or all types of human subjects research), Drugs, Privacy/Data Protection related legislations, regulations and guidelines but excluded Human Biological Materials, Genetic, Embryos, Stem Cells, and Cloning Research. It may be necessary to review all standards to obtain a full understanding of the country’s requirements.


Legislation – includes statutes, statutory instruments, legislative decrees, and constitutional provisions, if any, that relate to clinical research.
Regulations – refer to instruments that are created and issued under the name of governmental administrative bodies.
Guidelines – refer to non-binding instruments.


This legal information does not constitute legal advice or opinions as to the current operative laws, regulations, or guidelines of any jurisdiction. And new standards are issued on a continuing basis, this information is not an exhaustive source of all current applicable laws, regulations, and guidelines relating to clinical research. Researchers and other individuals should check with drug regulatory authorities or other relevant bodies before starting research activities.


Reproduced with thanks: Respective country  specific regulatory websites , information supplied by some regulatory officials and International Compilation of Human Subject Research Protections, 2009 Edition, Office for Human Research Protections, U.S. Department of Health and Human Services


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United Kingdom
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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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