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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.

Netherlands
Legislations
  1. Population Screening Act (1996)
  2. Medical Research Involving Human Subjects Act (2006)
  3. Medical Research (Human Subjects) Compulsory Insurance Decree (2003)
  4. Medicines Act (2007) (Dutch)
  5. Personal Data Protection Act (2004) (Dutch)

Regulations
  1. Concerning the Use of a Special Form (2002)
  2. Concerning Requirements of Expertise of Accredited Review Board Members (2002)
  3. Concerning the Organization and Working Method of Accredited Review Board Members (2003)
  4. External Review Guideline (2004)     
MHWS:
  1. Medicines Act Decree (2007) (Dutch)
  2. Medicines Act Regulation (2007) (Dutch)

Guidelines
  1. Manual for the Review of Medical Research Involving Human Subjects (2002)  
  2. CCMO: Clinical Research with Medicinal Products in the Netherlands: Instructional Manual (2005)  
  3. FMWV: Code for Adequate Secondary Use of Data (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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