Conditions for submission and approval of amendments
An amendment can only be approved if
- EC has provided a prior opinion on the initial protocol.
- An annual progress report was submitted (from the date of EC approval). If the study is not completed within one year, ICH-GCP requires that an annual progress report isprovided to the EC. A template can be found on this website.
General comments on submitting amendments
- A distinction is made between 'notifications,' 'substantial amendments,' and 'amendments for the participation of additional centers in a previously approved study' (see the overview at the bottom of these general comments).
- All centers participating in a particular study must have identical, final approved (versions of) documents.
- As stated in the previous paragraph, the documents (IB, IC, etc.) submitted as part of an amendment for the participation of additional centers in a previously approved study might not differ from the final approved (versions of the) documents held by the other centers.
- Please ensure that the reason(s) for submitting a (substantial) amendment are clearly stated in the cover letter and that the changes in the amended documents are highlighted.