Article
Who Are Your TMF Customers? The Key To Greater Trial Efficiency & Quality
December 2023 – TMF managers, begin now to prepare for ICH E6(R3) by employing quality by design (QbD)
for your next TMF. The “quality planning road map”, advocated by J. M. Juran, offers a guide to your journey.
Ken Keefer's latest Clinical Leader article discusses customer identification, the second step on the road map.
Identifying all TMF customers is critical to achieving TMF quality and efficiency.
Who Are Your TMF Customers? The Key To Greater Trial Efficiency & Quality (clinicalleader.com)
Article
Establishing TMF Quality Goals For Greater Trial Efficiency
September 2023 – J. M Juran taught that Quality by Design (QbD) begins with establishing quality goals.
Awareness of QbD grows as the draft Harmonised Guideline for Good Clinical Practice (GCP) E6(R3) progresses toward adoption by regulators.
When sponsors implement it fully, departments will collaborate in meeting critical-to-quality requirements tied to
strategic quality goals set by upper management. Trial designers and TMF teams can start employing QbD now to
transform the TMF into a tool for successfully managing trials.
Establishing TMF Quality Goals For Greater Trial Efficiency (clinicalleader.com)
Article
Designing Quality Into Your TMF: ICH E6(R3) And Advancing Trial Efficiency
July 2023 - J. M. Juran proposed a quality planning road map in
his 1992 book Quality by Design. The recent ICH draft “Harmonised Guideline for Good Clinical Practice
(GCP) E6(R3)” proposes applying quality by design (QbD) to clinical trials.
E6(R3) and increasingly powerful information technologies offer a new opportunity. Clinical trial sponsors can
now begin broadening the traditional document archival role of the trial master file (TMF) to a means
for improving trial quality and efficiency.
Designing Quality Into Your TMF ICH E6(R3) And Advancing Trial Efficiency (clinicalleader.com)
Article
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)
White Paper
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.
click to download PDF
White Paper
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.
click to download PDF
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