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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.
European-wide

Legislations
CoE:

  1. Convention on Human Rights and Biomedicine (Convention of Oviedo), Articles 15-18, ETS No. 164 (1997)
  2. Convention for the Protection of Individuals with Regard to Automatic Processing of Personal Data (1985)
  3. Recommendation No. R (97) 5 on the Protection of Medical Data (1997)


Additional Protocol on Biomedical Research, CETS No. 195 (2005)


EC:

  1. Directive 2001/20/EC
  2. Directive 2005/28/EC
  3. Data Protection Directive 95/46/EC of the European Parliament and of the Council (1995)


Regulations
EC:

  1. Detailed Guidance on the European Clinical Trials Database (EUDRACT Database) (2004)
  2. 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. Detailed Guidance for the Request for Authorisation of a Clinical Trial on a Medicinal Product for Human Use to the Competent Authorities, Notification of Substantial Amendments and Declaration of the End of the Trial (2004)


Guidelines

  1. EGE: Ethical Aspects of Clinical Research in Developing Countries (2003)
  2. EMEA: Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95) (1997)  
  3. EC: Notice to Applicants: Questions & Answers, Clinical Trial Documents (2005)
  		 


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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