The 3 Essential Skills Your TMF Team Must Have

Skill #1: How to Complete The Cycle of TMF QC

The life sciences industry faces a serious problem—a widespread trial master file (TMF) skills gap. There are simply not enough skilled TMF professionals to support the explosive growth and complexity of clinical research. The result of this skills gap is the rising incidence of TMF-related inspection findings that have the potential to delay patient access to lifesaving treatments.

That’s where LMK Clinical Research Consulting’s TMF University comes in. LMK’s TMF University is the first and only internationally recognized and accredited certification program for working TMF professionals. TMF University allows TMF professionals of all backgrounds to access real-time and asynchronous remote TMF learning courses tailored to meet learners at their level of expertise. Each course is competency based and supported with real-world case studies using high-quality simulated regulatory documents. Topics span from TMF fundamentals, such as the basics of document QC and indexing, to the advanced, including TMF regulation and TMF metrics and reporting.

To celebrate the overwhelming success of TMF University and the hundreds of accomplished TMF University graduates, we’ve decided to publish this blog series sharing the 3 skills we feel your TMF team must have to achieve TMF health.

The first skill on list is the subject of its own TMF University course: how to perform the cycle of TMF Quality Control (QC).

What Is The Cycle of TMF QC?

At its core, TMF QC is a complete cycle meant to continuously verify the current condition of the TMF in comparison to a predefined set of expectations. The TMF QC cycle is a business process that moves with and against the flow of data (not just following the flow of documents from site to sponsor). Although TMF University goes into greater detail about the six elements of the TMF QC cycle, those six elements can be summarized in three central actions:

  1. Set Expectations: Clear thresholds for quality must be established and customized for every TMF. Stakeholders should consider the desired level of TMF quality, the scope of documents to be reviewed, the frequency of review, the expected error rates, and the threshold for action.
  2. Plan Carefully: Before the first document is filed, TMF stakeholders must ensure that the TMF has a clearly defined scope, a matrix of responsibleness, and prospective timelines. Stakeholder should consider the expectations of regulators, available tools (e.g., the TMF Reference Model and eTMF system), and unique narrative progression of their clinical trial to develop a full list of expected documents.
  3. Verify and Align Continuously: The TMF must be reviewed continually against quality expectations and the TMF plan. Stakeholders must conduct ongoing review of the condition of the TMF to ensure it is complete, correct, and contemporaneous in addition to meeting quality expectations and adhering to the TMF plan. Stakeholders must take corrective action to fix issues in an orderly fashion, documenting their progress as they go.

Why Does TMF QC Matter?

LMK’s TMF Consultants often see document inventories or expected document checklists taking the place of the full cycle of TMF QC. While these inventories and checklists are valuable tools—and may even fulfill some of the elements of the cycle of QC—they are of limited utility when used in isolation and when the cycle is broken. For example, documentation of QC findings is only useful when those QC findings are used to perform corrective action to fix an issue. In the same way, a well-developed TMF plan is not useful if stakeholders are not clear on the expectations of TMF quality associated with their role.

In contrast, a complete TMF QC cycle continually verifies the condition of the TMF against expectations and rapidly remediates TMF quality issues before they become intrenched or widespread. The harsh reality is that a team that cannot perform the full cycle of TMF QC will never achieve TMF inspection readiness.  That’s why the skill of performing TMF QC is the number one item on our list of TMF Skills your TMF team needs to know. Without TMF QC, the inspection readiness of your TMF is unknown, and small errors can quickly compound into unacceptable regulatory risks.

You Can Close the TMF Skills Gap

Despite the critical importance and high stakes of TMF health, TMF experts have suffered from the harmful notion that TMF management is clerical work and that all TMF professionals are simply document reviewers. But this couldn’t be further from the truth. All of today’s TMF professionals must have advanced skills in project management and clinical operations oversight to achieve the ever-increasing expectations of regulators. The only solution to close this TMF skills gap is to invest in the growth of TMF professionals through modern and dynamic TMF education.

If you are a TMF professional looking for more real-world knowledge on how to jumpstart or revitalize your team’s cycle of TMF QC, check out our extensive library of blogs, case studies, articles, and webinars, many of which discuss the individual elements of the TMF QC cycle in greater detail. If you’d like to take your knowledge of TMF QC to the next level, visit to learn more about TMF University and enroll today!