TMF / Site Document Tracker (Excel Tracker)

Knowing exactly which essential documents are missing, expiring or inspection-ready across every site is a constant challenge without a live tracker. This Excel workbook gives you a single source of truth for Trial Master File completeness, built around the standard ICH-GCP E6(R2) Section 8 essential-document checklist.

What's inside:

• A Site Setup tab to record each participating site, country and PI
• A Required Documents List: a 20-item standard essential-document checklist (protocol & amendments, Investigator's Brochure, signed ICF template, IRB/EC approval letter and composition list, investigator CV, medical license, financial disclosure, delegation of authority log, lab certification, source document agreement, close-out visit report and more), each mapped to its ICH-GCP Section 8 reference and fully editable to match your own SOPs
• A TMF Document Log to record every document actually collected, one row per document per site, with Expected Date, Date Received, Expiry Date and an automatic Days Until Expiry / Status calculation
• Automatic flagging of documents as Missing, Received, Expiring Soon (within 30 days), Expired, or Not Applicable
• A live Dashboard showing overall and site-level TMF completeness, documents needing attention, and which sites are below 100% completeness
• Color-coded input cells, a full color legend and key definitions, and pre-filled example sites and documents

Who it's for: CRAs, TMF and regulatory coordinators, and site managers who need an inspection-ready, up-to-date view of essential document completeness without building a spreadsheet from scratch.

Format: One Excel workbook (.xlsx), fully editable, in English. Works in Excel and Google Sheets. Instant download after purchase.