Update: A downvoted post asked how to find that protocol or framework. I’d advise looking at MAPS’ site at http://maps.org/ http://maps.org/ - there are manuals

Update: A downvoted post asked how to find that protocol or framework. I’d advise looking at MAPS’ site at http://maps.org/ http://maps.org/ - there are manuals and protocols there - as well as tracking back to the source studies that the FDA is basing its decisions on and searching on Google Scholar for papers.