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TMF Reference Model Affiliation With CDISC Could Improve TMF Interoperability

March 2023 - The TMF Reference Model has affiliated with the Clinical Data Interchange Standards Consortium (CDISC). A transition is underway to make the model and its companion TMF Exchange Mechanism Standard full, formal CDISC standards. This article written by Ken Keefer and published by Clinical Leader suggests how better data integration could benefit regulators and help sponsors manage trials more effectively.

TMF Reference Model Affiliation With CDISC Could Improve TMF Interoperability (clinicalleader.com)

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Machine Learning and the Trial Master File: Improving Productivity and TMF Inspection-Readiness

September 2020 - Machine learning can quickly classify and index documents for filing in an eTMF. It also could potentially eliminate the need for time-consuming file exchanges that transfer documents between eTMFs. The result: simplifying processes and reducing costs.

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eTMF-EMS Business Case: Save Money And Stay Inspection-Ready With Timely TMF Content Exchange

May 2020 - An emerging standard reduces the complexity and cost of exchanging TMF content. With interoperability between different eTMF systems, sponsors can consolidate content from multiple sources without mapping or custom interfaces. The eTMF Exchange Mechanism Standard promises to reduce update backlogs and the risk of negative inspection findings.