The GCP guidelines are defined by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, shortly ICH. The quality standard encompasses the design, conduct, monitoring, analysis and reporting of clinical trials. It ensures in particular that the collected clinical data is accurate, complete and well documented and that the rights and confidentiality of trial subjects are respected.
During the period of the previous performance contract 2014-2017 that emphasised on the further development of clinical research at LIH, CIEC progressively advanced towards the GCP standard. This process was closely accompanied by LIH’s Quality, Health, Safety and Environment Unit. The audit was carried out by Strickland Quality Assurance Ltd, an experienced consultancy providing auditing and related services for all aspects of clinical trials. The CIEC will from now on be regularly audited on GCP.
In addition to being GCP complied, CIEC is active in providing GCP training to clinical investigators. A yearly workshop in different aspects of GCP for new or experienced investigators is organised in cooperation with the training providers EF-GCP and/or Cefira.
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