At the heart of every clinical trial is the trial master file. Despite the wide range of software solutions that exist to address other aspects of the clinical trial process, the trial master file is often a paper and binder-based system requiring manual updating and management. The move to an electronic trial master file (eTMF) involves connecting a broad set of stakeholders to a common system, and meeting the specific requirements of each of them, all in a system that addresses the full set of regulatory requirements defined by 21 CFR Part 11.
During this one-hour on-line session, you will see a complete demonstration of a SharePoint 2010 solution in action that provides a comprehensive solution for managing the trial master file as well as providing a portal available for a dispersed set of investigators and stakeholders and a system for ensuring timely and accurate distribution of safety reports.
Specific topics covered will include:
* How SharePoint 2010 can be configured for use and access by widely dispersed site managers, investigators and monitors
* How the DIA Reference Model for organizing clinical documents can be incorporated into SharePoint 2010
* A model for managing safety report creation and distribution with verification within SharePoint 2010