Francesca Spera -

The National Coordination Center of Ethics Committees for clinical trials on medicines for human use and on medical devices has recently published the updated version the agreement for the conduction of:

  • Clinical trials on medicinal products
  • Independent clinical trials on medicinal products
  • Clinical investigation on a non-CE marked medical device or CE marked but used outside the scope of its intended use

These models have been adopted according to the Art. 2 of Law 11 January 2018, no. 3, which attributes to the Coordination Center the same functions of coordination, guidance and monitoring of the evaluation activities of the related ethical aspects to clinical trials on medicines for human use delegated to the Ethics Committees.

Moreover, to ensure procedural uniformity in the application of Regulation (EU) no. 536/2014, the National Coordination Center has also released the template for the following documents:

  • Site-specific feasibility
  • Compensation for clinical trial participants
  • Declaration of interests
  • Curriculum vitae principal investigator

Considering this hot topic, that is currently being explored at European level, the proposed models could be further modified.

RPN will provide any further update and is available to provide full support for any query and for the submission of Clinical Trial Applications and relevant amendments.

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