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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.
Philippines
Regulations
  1. Rules and Regulations on the Registration, Including Approval and Conduct of Clinical Trials, and Lot or Batch Release Certification of Vaccines and Biologic Products (Administrative Order No. 47-a) (2001)

Guidelines
National Ethical Guidelines for Health Research (2006)
This document includes the following:
  • Ethical Guidelines for International Collaborative Research
  • Ethical Guidelines for Herbal Research
  • Ethical Guidelines for Complementary and Alternative Medicine Research
  • Ethical Guidelines for Epidemiological Research
  • Ethical Guidelines for Social and Behavioral Research
  • Ethical Guidelines for the Conduct of Research on Populations Traumatized in Emergencies and Disasters
  • Ethical Guidelines for HIV/AIDS Research
  • Ethical Guidelines for Research on Assisted Reproductive Technology
 
Ethical Guidelines for Clinical Trials on Drugs, Devices, and Diagnostics (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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