Once again, this year’s TMF Summit was an excellent opportunity to exchange thoughts and learn about the latest trends and practices around TMF management.

It was great to hear key Clinical Operations leaders describe how they get their teams to row in the same direction, unifying best practices and creating business processes that make for efficient teams and impact how the industry approaches trial master files.

This year, two specifically hot topics were systems integration and inspection readiness. How are they related?

Systems Integration

eTMF is an ever-growing and exciting movement; however, many potential users still require convincing of the value and as an essential component to save time and money and reduce risks. The TMF does not just include final documents, though. It contains significant versions of each essential document, providing a full picture of the study. The value becomes much clearer when the larger content management picture is taken into consideration. Fully integrated document management capabilities are key to author, edit, and approve documents and make it much easier to provide the complete picture to inspectors. Users are smart to be wary of completely standalone technologies to understand the value in an integrated approach to their content management needs across the lifecycle of a study.

Inspection Readiness

Many reported TMF inspection findings could be avoided by defining an integrated workflow and using a single platform across studies and the organization: One great thing about inspection requirements is the “freedom” to design your SOPs. This gives sponsors some control over their processes, but inspectors will expect results! This means that your e-clinical infrastructure has to align with your resources and SOPs, as well as regulations, among other considerations. Choosing a comprehensive system that can be configured to all of these variables is essential. 

Some common critical findings during inspections have included:

• The TMF was not defined
• Lack of quality control process
• Electronic folders did not reflect the appropriate index structure
• Inability to order documents by creation/version date
• Inability to set TMF to archive status to prevent further changes
• Previous versions of documents were not present
• Extensive duplication of scanned documents

You can learn more about the findings and how to avoid them in our recent white paper.

The right approach to technology is just a means to execute, though. People are key to successfully embodying best practices within the organization and committing to processes that will ultimately create efficiency and control risk. A healthy collaboration between stakeholders, daily business users, and external third parties (vendor/technology partners, CROs, etc.) is crucial.

Lessons Learned

1. Do more with less. Leverage technology to create efficiencies across clinical activities by standardizing training and SOPs and row together to accomplish the same goal.
2. TMF tells the story. Save and control draft documents. They provide a complete explanation of the trial. Inspectors might want to start at the beginning!
3. Plan your archiving. In Europe, archives must be maintained for 25 years. It is important to define responsibilities and study transfer processes with your CRO. This step is frequently forgotten, but it should be documented from the beginning.
4. Capture correspondence. Communications that show significant discussion around trial administration, trial conduct, protocol violations, or adverse event reporting should be found in the TMF. This correspondence includes significant decisions that impact the trial.
5. Know what inspectors want. Inspectors want to know where to find documents. At a minimum, they should be able to easy search your TMF documentation by document date, submitted, or published documents.

Learn more about how Trial Interactive can help with your TMF needs. Contact us at info@trialinteractive.com or visit our eTMF and TMF Management solutions pages for more information.