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Making the TMF Exchange Mechanism Standard Work
The TMF Exchange Mechanism Standard (EMS), now part of the CDISC TMF Reference Model,
specifies how to exchange documents among parties engaged in managing a clinical trial.
Success in employing EMS is grounded in a well-executed TMF Plan. Keefer Consulting helps clients augment
TMF planning with tailored document exchange programs that strengthen regulatory compliance, operational
efficiency, and trial management.
Operational Efficiency
Sponsors traditionally map document metadata between systems when exchanging content with CROs and other collaborators. Mapping is resource-intensive and time-consuming for TMF managers and study teams. It can distract attention and interrupt operations, especially when mapping for multiple sources.
Keefer Consulting works with eTMF vendors and system integrators to map proprietary metadata to a common standard protocol. Repeatable processes serving multiple exchanges become possible. Sponsors can avoid one-off mapping projects and forgo costly programming of custom interfaces. Clinical operations can prepare for inspections more easily, while lowering system migration and integration costs.
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Regulatory Compliance
Regulators have emphasized increasingly that a sponsor's TMF encompasses all essential trial documents, regardless of where they originate or are stored, and that sponsors are responsible for TMF completeness, quality, and timeliness. Sponsors must keep their TMFs inspection-ready while incorporating content from clinical research organizations (CROs), partners, and others. A TMF that is well-integrated with its document sources can support more frequent updates when appropriate throughout a trial. Negative TMF inspection findings are less likely and study teams can focus on managing successful trials.
Trial Management
Instead of storing out-of-date documents, a TMF well-integrated with its document sources allows more frequent updates. The TMF becomes a more effective trial management tool as study teams can access it for up-to-date trial information and readily identify project risks and opportunities.