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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.
India
Legislations
  1. Drugs and Cosmetics Act, Schedule Y (2005)
 
Regulations
  1. DCGI: Good Clinical Practices for Clinical Research in India (2001)

Guidelines
  1. NCESSRH:  Ethical Guidelines for Social Science Research in Health (2000)
  2. ICMR: Ethical Guidelines for Biomedical Research on Human Participants (2006)
  3. ICMR: Ethical Guidelines for Biomedical Research on Human Subjects: Statement of Specific Principles for Clinical Evaluation of Drugs/Devices/Diagnostics/ Vaccines/Herbal Remedies (2006)
  		 


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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