Expanded Access Protocol Registration Template Available: The Expanded Access Protocol Registration Template is intended to help investigators understand and gather the data needed to complete each registration module for an expanded access record. The template displays this information in a non-fillable Portable Document Format (PDF) file. (The template cannot be used to submit data directly to the Protocol Registration and Results System (PRS).) For a description of each data element, see the Expanded Access Data Element Definitions.
Results Display Changes: The design and display of study results have been modified to enhance functionality and usability.