REQUIRED DOCUMENTS FOR SUBSTANTIVE AMENDMENTS TO A SPONSORED CLINICAL TRIALS
  1. Formal letter of submission of the amendment drafted by the Sponsor / CRO with clearly marked:
    • the rationale of the amendment/s and the related contents;
    • list of the documents

Here is the facsimile form suggested by the IRCCS network of the Ministry of Health.

  1. text of the amended Protocol with all the highlighted changes from the previously approved version, dated and signed by the Promoter.
  2. any new document (ie informed consent form, letter to the  family doctor, list of centres ...) pointing out the changes from earlier versions approved by the EC;
  3. New economic agreements (if needed).
  4. Copy of the bank transfer. From January 2019 the payment of the evaluation fees for C. E. will no longer be required in advance, but will be invoiced only when the study / amendment is evaluated by the Ethics Committee. It is recommended to attach to the submission letter addressed to the OSR Ethics Committee the invoicing data form filled out with all the required data.
    The transfer must be received within 30 days of the invoice date.
More required documents:
  • Appendix 9 from Ministerial Centre Database, electronically compiled in hard copy, dated and signed by the Sponsor.
  • amended CTA form electronically filled out, in hard copy, dated and signed by the Sponsor.