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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.
Germany

Legislations

  1. Medicinal Products Act, Sections 40-42 (2007) (German)
  2. Federal Data Protection Act, as Amended (2003) [16 German states also have enacted laws about data protection in the non-federal public sector (German)]


Regulations

  1. BfArM:
    Promulgation on the Principles of the Conduct of Clinical Trials of Drugs According to the Rules (1987)
    Second Promulgation on the Clinical Trial of Drugs in Human (1997)
    Regulation for the Application of Good Clinical Practice of Clinical Medications for Human Use (2006)
  2. BMBF: Principles and Responsibilities Related to Clinical Studies (2003)


Guidelines

  1. BÄK: (Model) Professional Code of Conduct, Section 15 (2006) (German)
  		 


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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