Beyond Electronic Archive: Why Standard EDMS is Inadequate for Electronic Trial Master File
August 6, 2013
- eTMF Best Practices
Interview with Troy Deck in Drug Industry News
As published on June 25, 2013
Troy Deck of Wingspan explains why using a traditional Electronic Document Management System (EDMS) to manage TMF fails to deliver return on investment and falls short in ensuring compliance and audit-readiness.
Q: EDMS has been used in Life Sciences for years. Why aren’t they successful when used for eTMF?
A: Fundamental differences exist for eTMF documents and business processes that often can’t be addressed just by adding new features and functions to an existing EDMS framework. So while of course we need core EDMS features such as versioning, security and workflow, we also need other characteristics missing from many legacy systems.
Q: What are the key goals of eTMF that aren’t met by traditional EDMS?
A: To manage an eTMF actively and ensure regulatory compliance, an organization needs to understand what documents will be required, when they needed, and whether they have been received and quality checked. Traditional EDMS fails to provide insight into what is expected and when – instead focusing on managing what has been created or received, not on what might be missing.
Q: What specific features of the Wingspan eTMF support these goals?
A: Wingspan eTMF provides comprehensive features for planning, maintaining monitoring and measuring an organization’s TMFs. Studies are planned by executing a wizard and answering questions that determine which documents will be needed for a specific study based on the details of that study. Information from CTMS is used in conjunction to ensure consistency in study site information, milestones, investigators, and subjects across the eClinical landscape. The result is a study manifest that defines the entire set of expected documents for the study, with due dates based on associated study milestones. Standard EDMS does not normally accommodate planned documents, nor does it focus on providing due date for documents.
Q: What if the documents needed for the study change over time?
A: The system must respond to events in the trial, for example protocol amendments or safety events, by updating the list of expected documents appropriately. Furthermore, the eTMF must react to changes to the study reported by the CTMS, such as new investigators or sites, by updating the list of expected documents automatically.
Q: How does Wingspan eTMF support reporting and analysis?
A: Although every TMF is different, eTMF processes should be repeatable, with continuous process improvement as a goal. However, managing TMF performance and designing targeted interventions for problem areas is difficult if not impossible without effective metrics, not just search results masquerading as reports.
We provide an extensive set of customizable reports and metrics covering TMF completeness, quality, and timeliness, and supporting TMF/ISF reconciliation. Report criteria can be set to uncover trends (such as performance by specific CROs or countries), provide insight into problems and delays, or to report on audit-readiness of specific trials.
Q: How can our readers find out more about Wingspan eTMF?