Follow us on

Q of the week

Q: How Do You Get Shingles?

Get the Answer: 

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.
Switzerland
Legislations
  1. Federal Law on Medicinal Products and Medical Devices (2002)
  2. Federal Law on Data Protection (1992) (French)
  3. Regulation of June 14, 1993 Regarding the Release of Professional Secrets in the Area of Medical Research, RS 235.154 (French)
  4. Confidentiality in Medical Research (2006) (French)
Note: Many Swiss cantons have enacted laws regarding data collection in the public sector
 
Regulations
  1. Many of the Swiss cantons have implemented regulations regarding human subject research (French)
  2. Ordinance on Clinical Trials of Therapeutic Products, RS 812.214.2 (2004)

Guidelines
  1. SAMS: Guidelines on Human Research (1997)
  		 


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.
There are no events at this time

Links