Guidance to Principle Investigators for submissions of documents
Requesting an Amendment to an approved protocol
To request amendments to an approved protocol, the WHO TO is required to submit the following documents:
- A memo to the ERC requesting for an amendment(s), explaining why the amendment is required.
- A copy of the protocol (with the date or the version number on the title) with the amendment(s), the amendment(s) being in track change mode or highlighted.
- Where significant changes have been made in the study design, the amendment should be accompanied by proof that the amendment has been approved by the original peer review group.
Please give the Protocol ID of the Proposal in the subject line of the e-mail. This is provided in the ERC Review Summary that you receive at the end of a review.