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
- the rationale of the amendment/s and the related
- list of the 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.