The document discusses collaboration between the National Institutes of Health (NIH) and the Food and Drug Administration (FDA) to develop a standardized clinical trial protocol template. In 2015, the NIH-FDA Joint Leadership Council agreed to jointly create a template to improve protocol quality. A working group from both agencies reviewed existing NIH templates and drafted a phase 2 and 3 template, which was posted for public comments. The template was further revised based on feedback and aligned with TransCelerate's template. The finalized NIH-FDA template was released in 2017.