eTMF Hub

The Clinical eTMF hub site is a parent site fort each clinical trial workspace that is created on the hub. Reference list information that is relevant to all clinical trials is created and stored on the hub site. The out-of-the-box Clinical eTMF solution provides the reference lists that will be populated based upon a customer’s configuration. The lists can be populated manually, by deploying a package to the site (refer to Package Deployment), or from the customer’s Clinical Trial Management System (CTMS).

The site collection administrator adds a clinical trial from the hub site. The system uses the reference site information from the hub site to build the clinical trial workspace. The hub-level EDT template selected for the new trial populates the essential documents that will be tracked by the EDT workspace feature for that trial by creating a corresponding placeholder which is also referred to as a ‘requirement’ since the document is required.

When a new trial workspace is created, it is added to the Clinical Trials list and a link to the workspace is added to the hub site Clinical Trials web part.