Issue 27 – 22 Dec 2025

🎉Wishing you a wonderful holiday period!🎉

As we approach the end of 2025, we would like to wish everyone a restful break and a wonderful holiday season. Thank you for your ongoing dedication and hard work on the TRACK trial – your commitment continues to make a meaningful impact for our participants. We look forward to continuing working together in 2026 to conclude the study.

🎇 Thank You! 🎇

A big thank you to all sites and Regional Coordinating Centres for successfully completing all final visits and all follow up safety phone calls by the 31^st October 2025. This was a major milestone achieved, especially thank you to everyone involved in this process.

2025 Milestones ✨:

· All active participants from more than 60 sites across 12 countries have completed their final visits and follow‑up safety phone calls.

· 4,779 visits performed.

· 10,782 database queries resolved.

We recognise that this has been a very busy period, and we appreciate the continued efforts of site staff, CRAs, Regional Coordinating Centres and Project Global teams to meet tight timelines. We all should be proud of what we achieved together this year.

📢 Overview of Outcomes 📢

1st Primary Event

*All figures are as of 15 Dec 2025

📢 Important reminders 📢

1. Database Lock (December/2025 - in progress)

PI eCRF signing:

As part of the TRACK study close-out, Site Investigators are required to electronically sign all forms in the database once participants have completed the study and all data entry is finalised.

We will reach out to each site when they are ready for the soft database lock and request the site PI to sign the eCRFs for their site.

Step-by-step instructions for signing eCRFs in the database Zelta will be provided. All eCRFs can be signed in one go using the bulk signing function. This process should take no more than 10 minutes.

The database hard lock will happen after eCRFs have been signed for all active sites.

2. Close-out activities

Please ensure that any remaining close-out tasks are completed within the requested timelines so that we can finalise the study efficiently.

· IMP destruction – December 2025/ January 2026

Unused IMP and IMP returned by participants will be destroyed as part of the close out activities.

IMP Destruction Logs need to be completed and reviewed by the site CRAs and Global Project Team prior to destruction.

All destruction logs and destruction certificates (when applicable) must be shared with TGI.

Please contact CRA or Global Project Team if you have any questions regarding IMP destruction process for your site.

· Site invoices - December 2025 / January 2026

We are currently processing site participants payments. We appreciate if all invoices can be shared with TGI for payment in December 2025/ January 2026.

· Close out Monitoring Visits – January to March 2026

The close out monitoring visits will start from mid-January 2026. We expect that all close out monitoring visits will be completed by March 2026.

CRAs are going to start contacting sites to organise suitable dates for these visits.

📝 Thank You for 2025 📝

Thank you once again for your continued collaboration and support throughout 2025. Your efforts have been essential in bringing TRACK to this important stage. We wish you a safe and relaxing holiday period and look forward to working with you in 2026.

TRACK

Thank you for supporting the Track Trial.

To learn more please visit www.tracktrial.org

Warm regards,

The TRACK Trial team

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