Changes in the management of Clinical Trial Applications and amendments have recently been introduced in Italy.
A new version of the “Osservatorio Nazionale sulla Sperimentazione Clinica dei Medicinali” (OsSC) platform became active. The main updates concern:
- The need for digital signature through Smart Card/ USB token for any submission.
- The possibility for the Sponsor to electronically grant/revoke the delegation to a CRO to act as applicant on their behalf.
- The possibility to submit more than one substantial amendment at the same time, without having to wait for the assessment of an amendment by all parties involved before being able to submit another one.
- The inclusion of information for each clinical site in Appendix 10.
- The closure of the flows for a specific site/EC or for all the sites/ECs after submission of Appendix 11 (i.e. end of the trial in a single site) or Appendix 12 (i.e. end of the trial), respectively:
- The addition of a specific section for the clinical trial results, that will be enabled only after the submission of Appendix 12 (i.e. end of the trial).
- The access for the Italian Regions / Autonomous Provinces both for the validation of the Ethics Committees and the Health Facilities under their territorial jurisdiction and for the visualization of the data of the clinical studies conducted in sites located within their territory.
The use of the new portal will be mandatory for all submissions, including those which represented an exception in the past (e.g. submissions involving certain Ethics Committees).
Different possible situations could occur depending on whether a study had previously been managed within the OsSC or outside the OsSC and depending on the status of the assessments by Competent Authority and Ethics Committees at the time of the implementation of the new portal.
Regulatory Pharma Net is available to provide full support for any query and for the submission of Clinical Trial Applications and amendments through the new OsSC portal.