Using this guide

The guide defines the following:

  • Clinical eTMF architecture at a high level,
  • Hub site with its components,
  • How to add a clinical trial,
  • Clinical Trial Workspace with its components, and
  • Clinical Trial Document Processes.

Throughout the guide, symbols are used to call your attention to items of interest and items that require caution. Additionally, the symbols identifies recommended best practices. The symbols are:

Icon Description
Tip:
This symbol denotes an item of interest or provides further explanation.
CAUTION:
This symbol identifies that an action has the potential to adversely affect system performance or data integrity.
Warning:
This symbol provides a best practice methodology.