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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.
Ireland
Legislations
  1. Data Protection Act (1988), as amended (2003)
  2. European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations, 2004
  3.  European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations 2004 (S.I. No. 878 of 2004)
  4. European Communities (Clinical Trials on Medicinal Products for Human Use) (Amendment No. 2) Regulations 2006 (S.I. 374 of 2006)
  5. European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations 2004 to 2006 (Informal Codification Text)

Guidelines
  1. ICB: Operational Procedures for Research Ethics Committees: Guidance 2004
  2. IMB: Guide to Clinical Trials (2004)
  		 


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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