Protocol Toolset v1.0

Published Date:

The Protocol Toolset v1.0 provides the following tools to assist in implementation:

  • Study Outline Document Template - A template of suggested concepts for standardizing the Study Outline document.
  • Study Outline Concepts List - A detailed mapping between the Study Outline Concepts, BRIDG, and the SDTM Trial Summary Domain to serve as a reference for further explanation of the concepts and any related notes.