REQUIRED DOCUMENTS FOR SUBSTANTIVE AMENDMENTS TO A SPONSORED CLINICAL TRIALS
- Formal letter of submission of the amendment
drafted by the Sponsor / CRO with clearly marked:
the amended Protocol with all the highlighted changes from the previously
approved version, dated and signed by the Promoter.
document (ie informed consent form, letter to the family doctor, list of centres ...) pointing
out the changes from earlier versions approved by the EC;
economic agreements (if needed).
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. In the submission letter, the complete information for billing and correct address must be present for invoice receipt.
- the rationale of the amendment/s and the related
- list of the documents
The transfer must be received within 30 days of the invoice date.
- 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.