Completeness, timeliness, and quality

A percentage is not enough

Every TMF measure must answer:

• For which Study, Country, Site, milestone, process, and period?
• As of what date and time?
• Under which Filing Plan Revision and calculation rule?
• What was included in the denominator?
• What was excluded, and why?
• Which missing, late, rejected, additional-evidence, pending-decision, or exception-governed items sit behind the result?

Without those facts, the value cannot be reproduced or defended during inspection.

Measure snapshot

A measure snapshot preserves one calculation rather than continually rewriting yesterday’s result.

Field	Meaning
Measure	Completeness, Timeliness, or Quality
Scope	Study and optional Country, Site, milestone, process, artifact, owner, or period
As-of time	Exact cut-off and time zone
Filing Plan Revision	Rules governing the expected population
Calculation rule version	Approved definition used
Numerator and denominator	Exact counts and members
Excluded population	Items omitted and reasons
Pending decisions	Applicability questions not hidden in another status
Result	Count, percentage, or rate
Exceptions and findings	Items requiring interpretation or action
Produced by and time	Attribution

Completeness

Recommended study definition:

Required, applicable, due Filing Slots fulfilled by acceptable final Document Versions
──────────────────────────────────────────────────────────────────────────────────────
                 All required, applicable Filing Slots due by the cut-off

The detail must distinguish:

• not yet due;
• pending applicability decision;
• required and missing;
• received but not yet QC accepted;
• rejected;
• partially fulfilled;
• fulfilled;
• fulfilled late;
• not required with approved rationale;
• governed by an approved Exception Decision;
• additional evidence requiring reconciliation.

Rules:

1. Uploading a file does not make a Filing Slot complete.
2. An unacceptable or superseded version counts only if it is the exact applicable evidence for the period being assessed.
3. Not Required items are reported separately and require decisions; they are not silently removed.
4. Pending decisions remain visible and do not improve the measure.
5. Additional evidence never raises completeness above 100%; it is reconciled as duplicate, superseding/superseded, supporting, related to another slot, evidence of a missing slot, or unrelated.
6. Entering an actual milestone date does not force completeness to 100%.

Repeated occurrences are separate Filing Slots. They are never represented as a quantity hidden inside one slot.

Timeliness

Timeliness measures whether eligible final records were filed within the period defined by the Filing Plan Revision.

Each Document Expectation defines:

• the meaningful start event or date;
• the filing endpoint, normally the authoritative filing time;
• calendar-day or business-day calculation;
• applicable holiday calendar and time zone;
• allowed period;
• pause or exception rules, if any.

Recommended calculation:

Eligible Filing Slots fulfilled within their approved filing period
───────────────────────────────────────────────────────────────
       All eligible Filing Slots fulfilled or due by the cut-off

Filing a missing document late restores content completeness but does not erase the timeliness failure. Reclassification after the deadline must not reset the clock. The snapshot retains the original trigger, due date, first acceptable filing time, delay, and any approved exception.

Quality

Quality should not be reduced to one unexplained percentage. Report at least:

• open Critical, Major, and Minor findings;
• documents reviewed and documents with findings;
• finding rate by record type, country, site, responsible function, and cause where useful;
• repeat findings and reopened findings;
• overdue corrections;
• misfiles, duplicates, illegible records, wrong versions, and access issues;
• TMF-level reconstructability or retrieval failures;
• approved Exception Decisions separately from corrected deficiencies.

If a percentage is shown, preserve its exact numerator, denominator, population, review method, and severity treatment.

Milestone view

For a milestone, show together:

• planned and actual milestone dates;
• required Filing Slots due by that milestone;
• acceptable matches;
• missing, partial, rejected, and late slots;
• pending applicability decisions;
• open blocking quality findings;
• accepted operational exceptions;
• measure cut-off and rule version.

This lets a study lead understand the evidence gap without confusing operational progress with TMF health.

Changes and historical truth

A new Filing Plan Revision may change future expectations, due rules, or QC requirements. Historical measure snapshots retain the revision and rule used at their cut-off. A newly approved exception may produce a new snapshot but must not rewrite the old one.

Required refusals

• Refuse a metric without an as-of time and defined scope.
• Refuse completeness without an inspectable denominator.
• Refuse silent exclusion of pending or overdue items.
• Refuse a timeliness reset caused by refiling, metadata correction, or late QC acceptance.
• Refuse a quality score that hides open Critical or Major findings.
• Refuse a claim of 100% readiness based solely on completeness.