Webinar Recap: Insights from the CDISC and TMF US Interchange Conference

Webinar Recap: Insights from the CDISC and TMFUS Interchange Conference

We kicked off with Cassandra Andrade, who warmly welcomed the attendees and introduced her co-hosts, Gillian Gittens and Ben Rogers. Cassandra acknowledged familiar faces from recent events, like the CEDA’s conference, underscoring the vibrant network joining this webinar.

Ben Rogers shared critical takeaways from the CDISC conference, highlighting his dual role as both an educator and presenter on behalf of LMK and TransPerfect. His focus was on evolving TMF practices, particularly the impact of standardization initiatives, such as the TMF Reference Model, M11, and R3. Ben emphasized the need for standardizing protocols and metadata to enable more efficient, real-time decisions across teams, ensuring organizations stay up-to-date in the rapidly changing industry landscape.

One key highlight was Ben’s call to action: get involved in the TMF Reference Model updates and future initiatives. Ben explained that everyone’s feedback is valuable—whether it’s grievances or practices that have worked well. The TMF Reference Model V4 team is actively seeking input from professionals across clinical research, emphasizing the importance of broad-based contributions.

Gillian Gittens also shared significant insights from the V4 initiative. She illustrated how the TMF Reference Model is adapting to digital advancements and interoperability, making it not just a repository but a digital backbone for clinical trial documentation. Jill encouraged newcomers and experienced professionals alike to actively engage, emphasizing that multiple voices make a difference in shaping the model.

The panel tackled questions about CRO partnerships and oversight challenges, offering practical advice on managing TMF quality when working with CROs. Both Ben and Gill underscored the importance of establishing robust, risk-based oversight procedures tailored to organizational needs and history. They discussed how sponsors could employ sampling techniques and strategically adjust their approach to ensure consistent quality without budget overreach.

Finally, the FDA inspector’s presence at the conference brought a wealth of insights, particularly on inspection readiness. The FDA highlighted the need for day-to-day TMF management and transparent documentation practices. Notably, the inspector emphasized training: sponsors should ensure that all team members, including those from CROs, understand how to navigate the TMF effectively. The message was clear—be proactive, stay organized, and treat TMF management as a continuous process to avoid last-minute issues in inspections.

Key Takeaways:

Get Involved: Contribute to TMF Reference Model V4 with ideas, feedback, and involvement in committees.
Focus on Standardization: Stay current on industry changes and prepare for digital transformation initiatives like M11 and R3.
Enhance Oversight: Establish risk-based oversight tailored to your organization’s needs to ensure TMF quality with CROs.
Be Inspection Ready: Regularly maintain your TMF, and ensure training for all involved, as the FDA expects consistent quality and preparedness.