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.
Portugal
Legislations
  1. Oviedo Convention on Human Rights and Biomedicine (2001)
  2. Approval of the Applicable Legal Standards for the Conduct of Clinical Trials of Medicines for Human Use, Law No. 46/2004
  3. Approval of the Composition, Operations, and Financing of the Ethics Commission for Clinical Research, Decree No. 57/2005 (Portuguese)
  4. Constitution, Article 35 (1997)
  5. Act on the Protection of Personal Data, No. 67/98 (1998)

Regulations
  1. Decree-Law No. 102/2007 of April 2

Guidelines
  1. Opinion 4/CNE/93 on Clinical Trials (1993)
  2. Opinion 9/CNE/94 on Ethics Commissions (1994)
  3. Doc. 13/CNECV/95 on Legislation on Clinical Trials and Ethics Committees (1995)
  4. Doc. 34/CNECV/2001 on the Helsinki Declaration (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.
There are no events at this time

Links