What is Good Clinical Practice (GCP) and ISO 14155?


Definition from EU Directive 2001/20/EC, article 1, clause 2:


      “Good clinical practice is a set of internationally recognized ethical and scientific quality requirements which must be observed for designing, conducting, recording and reporting clinical trials that involve the participation of human subjects.”

SO 14155:2011 is titled:

Clinical investigation of medical devices for human subjects - Good clinical practice" 


The new standard appears to be largely harmonized with ICH clinical study guidelines. It addresses the technical aspects of clinical investigations carried out in human subjects to establish the performance and safety of medical devices for regulatory purposes by defining procedures for their design, conduct, recording and reporting.



  • +972 52 6134368
  • P.O.Box 7746 Haifa, 3107701, Israel