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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.
Singapore
Legislations
  1. Medical Registration Act (Cap. 174) (1985)
  2. Medicines Act Section 74 (Cap. 176) (1975)
  3. Medicines (Clinical Trials) Regulations (2000)
  4. Health Products Act (2007)
  5. Computer Misuse Act (Cap. 50A) (1993)

Regulations
  1. MOH: Directive of June 25, 1998: Hospital Ethics Committees
  2. Singapore Guideline for Good Clinical Practice (1998)

Guidelines
  1. NMEC: Ethical Guidelines on Research Involving Human Subjects (1997)
  2. BAC: Research Involving Human Subjects: Guidelines for IRBs (2004)
  3. MOH:Governance Framework for Human Biomedical Research (2007)
  4. MOH: Operational Guidelines for IRBs (2007)
  5. MOH: Advisory on Data Protection Standards for Electronic Medical Records (EMR) Systems (2002)
  6. NMEC: Recommendations On Clinical Trials: Update Focusing On Phase I Trials (2007)
  7. BAC: Personal Information in Biomedical Research (2007)
  		 


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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