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ICH E6(R3) And Defining What Is Critical To TMF Quality
Article | Ken Keefer, April 9, 2024
The impending adoption of ICH E6(R3) promises to elevate the role of the TMF and increase trial efficiency. The GCP guideline will require sponsors to practice quality by design (QbD), an approach that starts with designing quality into every product and service. This article explores possible effects of ICH E6(R3) on the scope of TMF services, the importance of understanding TMF customer needs, and how applying QbD could improve TMF and trial quality.
ICH E6(R3) And Defining What Is Critical To TMF Quality (clinicalleader.com)
Who Are Your TMF Customers? The Key To Greater Trial Efficiency & Quality
Article | Ken Keefer, December 12, 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. This 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)
Establishing TMF Quality Goals For Greater Trial Efficiency
Article | Ken Keefer, September 14, 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)
Designing Quality Into Your TMF: ICH E6(R3) And Advancing Trial Efficiency
Article | Ken Keefer, July 17, 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)
TMF Reference Model Affiliation With CDISC Could Improve TMF Interoperability
Article | Ken Keefer, March 20, 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 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)
Machine Learning and the Trial Master File: Improving Productivity and TMF Inspection Readiness
White Paper | Ken Keefer, 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.
eTMF-EMS Business Case: Save Money And Stay Inspection-Ready With Timely TMF Content Exchange
White Paper | Ken Keefer, 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.