Conditions for submitting and approving amendments
An amendment can only be approved if:
- The EC previously formulated a favourable opinion regarding the initial protocol.
- An annual progress report was submitted (from the date of EC approval). If the study has not been terminated within one year, ICH-GCP requires an annual progress report to be submitted to EC. A template can be found on this website.
General remarks about submitting amendments
- A distinction is made between 'Substantial amendments' and 'Amendments for participation of additional centres in a previously approved study' (see overview at the bottom of these general comments).
- All centres participating in a particular study should have identical, finally approved (versions of) documents.
- The previous paragraph shows that the documents (IB, IC, etc.) submitted in the context of an amendment for participation of additional centres in a previously approved study should not differ from the finally approved (versions of) documents available to the other centres.
- Please always clearly specify the reason(s) for submitting a (substantial) amendment in the cover letter and indicate the changes in the amended documents.
Amendments can only be submitted digitally. Read more about submitting documents.