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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.

Israel
Legislations
  1. Public Health Order (1940)
  2. Privacy Protection Act No. 5741 (1981) (Hebrew)
  3. Protection of Privacy Law No. 5741, as Amended by Law No. 5745 (1985)

Regulations
  1. Public Health Regulations (Medical Experiments Involving Human Subjects) (1999) (Hebrew)
  2. Public Health Regulations (Clinical Studies in Human Subjects) – 1980 (Hebrew) with Amendments on 1990, 1992, 2005 (Hebrew)

Guidelines
  1. Guidelines for Clinical Trials in Human Subjects (2006) (English)
 
 


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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