Introduction

Use this guide understand the components of the Clinical eTMF feature and how they interact within the baseline Clinical eTMF solution.

The Clinical eTMF feature offers the structure and functionality needed to create and manage Clinical Trial documents through the use of SharePoint workspaces. It provides the lifecycle and workflows that facilitate the creation of new trials and subsequent review and approval of electronic Trial Master File (eTMF) documents. Additionally, it facilitates clinical team interactions and provides access to all members based upon their role and their trial responsibilities.

The features defined in this document may vary depending on the local configuration and requirements.