Improving Inspection Readiness Using Milestones and Expected Document Lists

Improving Inspection Readiness Using Milestones and Expected Document Lists

TMF inspection readiness is measured by three factors: TMF completeness, quality, and timeliness. Historically, these metrics were difficult to track using paper-based TMFs. Even with electronic trial master files (eTMFs), tedious manual processes made inspection readiness challenging to assess in real-time. In response, two new features have been added in Veeva Vault eTMF: expected document lists (EDLs) and milestones.

One top-50 global pharmaceutical company has made EDLs and milestones integral to their TMF management approach. The company’s extensive experience can serve as a best practice guide in leveraging these capabilities to drive continuous TMF inspection readiness.

Milestones and EDLs Defined

Milestones measure TMF completeness throughout study execution, using associated documents. Vault eTMF shows the state of the milestone at a glance – complete, in progress, or not started.

An EDL is a checklist of all the documents collected to reach the milestone. As with milestones, Vault eTMF reveals the state of progress for documents within each EDL.

These capabilities focus on achieving precise and efficient TMF inspection readiness in two ways. First, by making completeness tracking proactive and routine. Second, by enabling completeness at large scale.

Moving Toward an Active Approach

The global pharma company encourages its users to view TMFs not just as passive repositories, but as a means of actively managing studies to ensure a constant state of inspection readiness. Vault eTMF enables active TMF operations by managing all TMF documents, related information, and processes in the same system as they’re executed.

Documents are managed in real-time, giving study teams full visibility into TMF completeness. Interactive dashboards provide at-a-glance views of what’s required, what’s completed, and what’s missing at all times, allowing users to take remedial action as needed.

In moving toward active TMF management, the company found that a direct EDL uploading model greatly improves completeness. Efficiency increases when on-site CRO monitors upload documents directly into the TMF rather than sending them to a central team to upload.

In a comparison of the two models, the study using central uploading achieved 49% completeness, whereas the direct uploading model reached 92%. When CRAs cannot handle uploading themselves, better communication between TMF operations and the on-site document collection team is highly beneficial.

Real-World Best Practices

The company currently has 22 studies in progress using both EDLs and milestones and an additional 55 using EDLs alone.

They generally maintain EDLs on a monthly basis to ensure that inspection readiness is assessed against up-to-date information. EDLs are exported into Microsoft Excel, with columns added to track issues and remediation. Vault eTMF lets you create visual dashboards and reports to simplify and speed analysis. Dashboards make it easier to see where to focus, leading to improved feedback, higher return on completion metrics, and faster issue resolution. Owing to these advantages, the company has prioritized deploying EDL and milestone dashboards for internal staff and external CRO users alike.

Metrics from the dashboards are presented at regular site team meetings to give users and CROs at-a-glance visibility into TMF status. Milestones over 30 days past due are escalated to senior TMF specialists. They, in turn, consult with the CRO to determine whether documents are missing and need to be uploaded. Once all document classifications are complete in Vault, the milestone gets a finish date certifying that the relevant documents are appropriately filed in the TMF.

Working Smarter, Not Harder

Here are other keys to success:

• Build EDLs and milestones into SOPs, SOIs, job aids, work instructions, and reference tools. The underlying idea is to bake them seamlessly into TMF processes rather than keeping them siloed as separate tools.
• To ensure that information is always current, establish defined timing and frequency of EDL and milestone uploads, updates, and reviews.
• Custom-tailor EDLs and milestone templates to your organization’s needs, and stay open to periodically reassessing them. Make appropriate modifications to enhance accuracy, improve completeness, and reduce effort.

Driving Adoption

To incorporate EDLs and milestones into your own TMF practices, the company recommends piloting them and involving one or two strategic CRO partners in the effort. Solicit CRO input and participation to ensure they are fully on board, understand what’s expected, and actively embrace the innovation.

Ultimately, EDLs and milestones are a vast improvement over the traditional process of gathering information from large spreadsheets or clicking around endlessly in the library. By incorporating these features into an active TMF operating model, a constant state of inspection-readiness is achieved, leading to significant gains in compliance, visibility, and process improvements that streamline the entire study process.

For more tips on leveraging Vault eTMF for active TMF management, watch this on-demand webinar to hear how Daiichi Sankyo uses milestones and EDLs to support inspection readiness.