Francesca Spera -

According to the Regulation (EU) no. 536/2014, the evaluation of a clinical trial application in CTIS includes three main steps:

  • validation
  • evaluation
  • final decision

The evaluation phase can take up to 45 days, which can be extended by a maximum period of 31 days if requests for additional information are made.

The process includes Part I and Part II evaluations (which may or may not occur at the same time) that end with two respective assessments.

Part I assessment consists of a joint assessment of the concerned Member States led by the Rapporteur Member State, which presents the final decision, while Part II consists of a separate assessment carried out by each Member State.

In Italy, the Ethics Committees assess the aspects included in Part II independently and are responsible for presenting the relevant conclusion.

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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