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Ken Keefer describes emerging data standard to accelerate inspection preparation

RSIDM 2020 presentation highlights how the eTMF Exchange Mechanism Standard could help sponsors improve inspection-readiness while reducing delays and costs

Rockville, MD, Feb. 11, 2020 – Ken Keefer, Principal Consultant for Keefer Consulting Inc., addressed regulatory affairs practitioners at the DIA Regulatory Submissions, Information, and Data Management Forum (RSIDM 2020), explaining how the eTMF Exchange Mechanism Standard (eTMF-EMS) could help sponsors accelerate inspection times. ”Current problems in exchanging TMF content require a solution that helps us reduce backlogs of updates to the TMF. Effective use of eTMF-EMS could eliminate custom programming, allow sites, CROs, and other TMF contributors to work in their own systems, and reduce the risk of negative inspection findings”

Joanne Malia, Director of Clinical Documentation Management at Regeneron, chaired the session titled “Inspection Readiness: TMF Data Quality and Completeness Progress”. Mr. Keefer followed co-speaker Vera Buris, Senior Manager of Quality and Operations, Submission Sciences at Biogen, who presented the topic “Evolution of TMF: A Case Study to Building a Successful TMF”.

Sponsors, CROs, and eTMF vendors employ different metadata conventions to describe TMF documents. They reconcile differences for each exchange by mapping the sending party’s metadata to that of the receiving party. They may enter metadata manually in creating records that correspond to the ones they receive, or they may pay for custom programming to automate this process. Many companies avoid possible delays by transferring all content at end-of-study. Problems in quality, timeliness, or completeness may emerge as inspection or submission dates loom.

The TMF Reference Model defines metadata and a taxonomy for TMF content, but it is not an enforceable standard. Companies may choose whether to adopt the model and how to use it. It does not provide standards for metadata, audit trails, or electronic signatures. It does not specify how to exchange electronic TMF content.

eTMF-EMS offers a metadata standard that eliminates the need for custom mapping. Instead, each software vendor maps its metadata once to a common eTMF-EMS protocol. Sponsors and CROs can exchange their metadata in either direction with any compliant system. Future versions of eTMF-EMS could facilitate multiple transfers over the course of a study. Keeping TMF content current could reduce preparation times and costs for inspections and submissions. This could free managers to focus on quality, timeliness, and completeness.

The presentation included use cases to help participants assess eTMF-EMS for their organizations, costs and benefits to consider when outlining an eTMF-EMS business case, and critical success factors and risks to aid in planning an eTMF-EMS project.

“Timely exchanges of content could help companies prepare for inspections more quickly. Sponsors could achieve timeliness, completeness, and quality across multiple eTMF systems. More efficient processes would reduce the costs of migration and integration. I suspect that many companies could explore this area more fully by comparing the cost of adopting eTMF-EMS with their current costs of mapping TMF metadata.”

In closing, Mr. Keefer urged participants to do the following in their organizations:

  1. Assess the advantages of the electronic Trial Master File Exchange Mechanism Standard (eTMF-EMS) for specific use cases.
  2. Outline an eTMF-EMS business case, based on projected costs and benefits.
  3. Recognize critical success factors and risks when planning to exchange TMF content, based on eTMF-EMS.

About Keefer Consulting Inc

Keefer Consulting Inc. helps vendors of regulatory information management software and services capture the interest and trust of biopharma prospects and customers. Keefer Consulting clients demonstrate expertise and an understanding of customer needs with white papers written by Ken Keefer that provide practical perspectives based on research.

Founded in 1989 in Philadelphia, Pennsylvania, Keefer Consulting has provided business analysis, data architecture, and project management services to clients. Kenneth Keefer, MBA has devoted more than a quarter of his career helping biopharmaceutical and healthcare companies improve business processes and manage data. Follow Keefer Consulting on LinkedIn https://www.linkedin.com/company/keefer-consulting-inc.

The Drug Information Association (DIA) is “a global association that mobilizes life science professionals from across all areas of expertise to engage with patients, peers and thought leaders in a neutral environment on the issues of today and the possibilities for tomorrow.” (https://www.diaglobal.org/en/about-us, retrieved March 4, 2020). Consistent with the disclaimer applicable to all RSIDM 2020 presentations, “The views and opinions expressed in [this article] are those of the individual presenter and should not be attributed to DIA, its directors, officers, employees, volunteers, members, chapters, councils, Communities or affiliates, or any organization with which the presenter is employed or affiliated.”

Contact

Ken Keefer, Principal Consultant
215-461-1601, kkeefer@keeferconsulting.com