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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.
Finland

Legislations

  1. Medical Research Act No. 295/2004
  2. Medicines Act and Decree No. 296/2004
  3. Personal Data Act No. 523/1999
  4. Act on the Amendment of the Personal Data Act No. 986/2000


Regulations

  1. MSAH: Decree on the National Advisory Board on Health Care Ethics No. 494/1998
  2. Decree on Medical Research and Subsidiary Regulations Issued in Pursuance Hereof, No. 898/1999, as amended 313/2004
  3. Decree on the National Research Ethics Council of Finland No. 1347/2002
  4. NAM: Administrative Regulation on Clinical Trials on Medicinal Products in Human Subjects No. 2/2004
  5. MSAH: Decree on Clinical Trials No. 316/2005


Guidelines

  1. TUKIJA: Checklist for Researchers and Members of Ethics Committees (2001)
  		 


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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