Valentina Ciurlia -

Starting from January 31st, 2023 the new clinical trial applications have to be submitted only through the Clinical Trial Information System (CTIS) in accordance with EU Regulation 536/2014.

The CTIS is the current portal for Sponsors and Competent Authorities/Ethics Committee for the submission and assessment of clinical trials in Europe.

Thus, from January 31st, 2023, the submission of new clinical trials via the “Osservatorio Nazionale sulla Sperimentazione Clinica dei Medicinali (OsSC portal)” is no longer possible.

The OsSC portal will remain active only to:

  • upload the previous clinical trials submitted by January 30th 2023;
  • manage the studies (e.g. amendments submission, EoT communication, site addition) submitted via OsSC portal by January 30th 2023 (this will be possible until January 30th 2025).

From January 31st, 2025 all clinical trials will be submitted and managed only through the CTIS portal.

RPN will provide any further update and is available to provide full support for any query and for the submission of new Clinical Trial Applications and relevant amendments through the CTIS portal and for the management of ongoing clinical trials in this last transition period.

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