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.
Brazil
Legislations
  1. CNS: Decree 98 830: Collection by Foreigners of Data and Scientific Materials in Brazil (1990) (Portuguese)

Regulations
  1. CONEP: Resolution 196/96: Rules on Research Involving Human Subjects (1996)
  2. Resolution 304/2000: On Complimentary Rules for Research Involving Indigenous People (2000)
  3. Internal CONEP Regulation (2001) (Portugese)
  4. Regulation of Resolution CNS 292/99 on Research with Foreign Cooperation (2002) (Portuguese)
  5. Resolution 346/2005: On Multicenter Research (2005) (Portuguese)
  6. CNS: Resolution 251/1997: On Complimentary Rules for Research with New Pharmaceutical Products, Medicines, Vaccines, and Diagnostic Tests (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