As Bob Dylan sang many years ago, “For the times they are a-changin,”1 could be the motto of drug development. Regulations, requirements, and enforcement practices have changed, and industry professionals strive to maintain awareness in order to be compliant. As the number of clinical trial site locations outside of the U.S. has increased — driven by untapped populations, faster recruitment, and lower costs,2 — the challenges have added up. Regionally, the required or anticipated documentation and enforcement of those requirements has changed over time. One document that has recently garnered attention is the FDA Form 15723 and specifically its use by non-U.S. investigators.