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 demonstration of a SharePoint 2010 solution in action that provides a comprehensive approach to managing the eTMF and clearly accelerates clinical site startup processes.
Specific topics covered will include:
- How SharePoint 2010 is used by widely dispersed sponsor and contract research personnel to manage the trial master file
- How the study, country and site specific checklists can be defined to track the documents that have been received into the eTMF and which are still missing
- How notifications of document-driven study milestones can be automatically communicated to key stakeholders
To find more information please click here: nextdocs: Managing Clinical Documents and Processes with SharePoint 2010 - Complimentary Webinar
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