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.
Slovenia
Legislations
  1. Oviedo Convention on Human Rights and Biomedicine (1998)
  2. Additional Protocol on Biomedical Research (2006)
  3. Personal Data Protection Act No. 59 (1999)
  4. Act Amending the Personal Data Protection Act No. 57/2001

Regulations
NMEC:
  1. Ministerial Decree No. 30 (1995)
  2. Statutory Notes (1998)
  3. Slovenian Directive on Clinical Drug Testing No. 67.8372-8385 (2000)
  4. On the Ethical Review of Phase IV Clinical Studies (2003) (Slovenian)

Guidelines   
  1. Slovenian Code of Medical Deontology, Articles 47-50 (1992)
  		 


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