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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.
Romania
Legislations
  1. Law 336/2002
  2. Oviedo Convention on Human Rights and Biomedicine (2001)
  3. Law No. 667/2001 on the Protection of Individuals with Regard to the Processing of Personal Data and on the Free Movement of Such Data

Regulations

  1. Ordinance No. 57/16.08.2002 (2002)
MOH:
  1. Emergency Ordinance 152/1999 on Medicinal Products for Human Use
  2. Order of MOH No. 1300/2004: Detailed Guidance on the Application Format and Documentation to be submitted in an Application for an Ethics Committee Opinion on the Clinical Trial on Medicinal Products for Human Use (2004)
  3. Order of MOH No. 1117/2004: Detailed Guidance for the Request for Authorization of a Clinical Trial on a Medicinal Product for Human Use to the Competent Authorities, Approval of Substantial Amendments and Declaration of the End of the Trial (2004)
  4. Order of MOH No. 904/25.07.2006 Transposing Directive 2001/20/EC of the European Parliament and of the Council (2006)

Guidelines
  1. MOH: Guideline for Clinical Trials in Pediatric Populations (CPMP/ICH/2711/99) (1999)
  		 


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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