Reference no: EM133661038

Explanation on how to do it: make a protocol amendment submission, prepare a cover letter 1571 form, and then you just download an Internet protocol. you take a known protocol. When you do these submissions, you submit something called an annotated protocol. So, it's protocol with a track change. So, you can write the same protocol and you save it as a clean version, and then you save one as an annotated, and then you submit also something called a summary of changes. So there's those 5 documents is what gets submitted. And you're gonna link them together in a zip file. So it's a 1571, a cover letter, a clean protocol, which you just take a protocol, save it as a file, as clean, and then an annotated protocol, and you just take the same file and save it as annotated. And then, lastly, a summary of changes where you have initial change and rationale