This is a ready-to-use periodic TMF metrics document. It is the quantitative artifact a periodic TMF review produces and an inspector reads: the numbers behind completeness, timeliness, and quality, broken down by site, trended over time, and turned into owned actions. It is a companion to, not a replacement for, a review-activity checklist: the checklist scores governance items pass or fail, this artifact carries the measurements those items are judged against. Replace every <<FILL: ...>> placeholder with your own specifics. A filled specimen follows. This is general guidance to adapt, not legal or regulatory advice.
1. Purpose and reporting basis
This document measures the Trial Master File against the tailored study TMF Index for the period stated above. Completeness is weighted by artifact criticality so that a missing IRB/IEC approval is not scored equal to a missing administrative letter; the weighting basis is stated in <<FILL: TMF Plan section reference>>. Timeliness is measured from the trigger event to the file date, not the upload date, per the ALCOA+ contemporaneous principle.
2. Completeness
2.1 Trial-level and site-level completeness
2.2 Sites below target
List every site scoring below the completeness target, so a strong trial-level average cannot hide a struggling site.
3. Timeliness
Sites with a repeated late-filing pattern in the critical tier are named here, since a single trial-level timeliness number can mask one or two sites driving the whole gap.
4. Quality
5. Placeholders and exceptions
6. Reconciliation status
7. Actions
Every metric below target from sections 2 through 6 carries a named owner and a date; a metric stated with no action is treated as a finding in itself.
8. Overall health narrative and conclusion
<<FILL: two to four sentences stating the overall TMF health for the period, e.g. green/amber/red, the one or two items driving that call, and whether the trend is improving or worsening versus the prior period.>>
9. Distribution and next issue
10. Approvals
11. Revision history
Filled specimen
The following shows one reporting period completed for an illustrative study. Numbers are illustrative; replace with your own.
Study: Protocol XYZ-201. Reporting period: 01 July 2026 to 31 July 2026.
Sites below target: Site 04 at 84% weighted completeness, missing 1 IRB amendment approval and 2 monitoring visit reports; Site 11 at 87% weighted completeness, missing 1 delegation log update after a sub-investigator change.
Site timeliness pattern: Site 11, critical-tier timeliness 92% this period, repeated pattern over 2 consecutive periods, tied to the same delegation-log gap noted above.
Quality: QC first-pass rate 89% (target >=90%, watch), misclassification rate 2.4% (target <2%, action); monitoring visit reports escalated to 100% review at Site 04 after a sample of 32 found 2 misclassifications against an acceptance limit of 1.
Actions: Chase Site 04’s outstanding IRB amendment approval and 2 monitoring visit reports, owner TMF Lead, due 5 business days, open. Complete Site 11’s delegation log update and refresh coordinator training on triggering it at personnel change, owner CRA, due 10 business days, open. Run the 100% review of Site 04 monitoring visit reports and a root-cause check for the misclassification pattern, owner Clinical QA, due 15 business days, open.
Health narrative (specimen): Overall TMF health is amber this period. Trial-level completeness at 93% weighted is within a normal range for mid-study, but two sites are notably below target and standard-oversight timeliness has declined from 95% to 91%, driven largely by Site 11’s delegation-log gap. Quality shows one artifact type (monitoring visit reports at Site 04) failing sample QC, now under 100% review. No critical-tier or high-risk artifact is affected. Trend is worsening versus the prior period on timeliness and holding flat on completeness; all four items above carry an owner and a due date.
Common inspection findings this document prevents
- Metrics reported at trial level only, hiding one or two sites driving the real risk.
- A percentage reported for months with no remediation, which reads as the organization knowing about a gap and not acting.
- Timeliness measured from the upload date instead of the trigger event, which corrupts the contemporaneous claim.
- Quality sampling results not connected to a triggered 100% review when the acceptance limit is exceeded.
- No health narrative or conclusion, leaving a reader to guess whether a set of numbers is actually acceptable.
How to adapt this document
- Set your study, reporting cadence, and targets in the header and tables; do not ship the placeholder targets.
- Match the artifact tiers in section 3 to the tiers defined in your TMF Management Plan.
- If your eTMF exports metrics natively, reference the export and reproduce only the rows that need a narrative or an action, rather than duplicating the full system output here.
- Keep the site-level breakdown even when the trial-level number looks acceptable; that breakdown is what section 2.2 and the timeliness pattern table exist for.
