Expected TMF content

From plan to concrete expectations

A Document Expectation is a rule in a Filing Plan Revision. A Filing Slot is one concrete application of that rule.

Document Expectation
“For every completed site initiation visit, expect one final visit report.”

                         generates
                            ↓

Filing Slot
“Site initiation visit report for Site DE-014, visit completed 12 May 2026.”

Keeping these meanings separate allows the study team to explain why a record was expected, which event created the need, and whether a later plan revision changed future expectations.

Document Expectation

Fields

Field	Meaning
Filing Plan Revision	The approved instructions that created the expectation
Artifact or local record type	The kind of evidence expected
Plain-language reason	What activity, decision, or oversight the record demonstrates
Filing level	Study, Country, Site, Person, Organization, Product, Committee, or defined Event
Applicability condition	The trial facts that make it applicable
Requiredness	Required, Not Required, or Pending Decision
Count rule	One, a stated number, one per event, or another explainable calculation
Trigger	Approval, visit, amendment, shipment, meeting, closeout, or other source event
Meaningful document date	Signature, approval, visit, issue, effective, expiry, receipt, or other defined date
Due rule	What starts the clock and how the deadline is calculated
Responsible contributor	Who should provide or create the record
Accountable function	Who ensures the expectation is resolved
Milestone	The operational point at which this content is assessed
QC requirement	Required review, sampling rule, and blocking criteria
Blinding/privacy rule	Who may see and process the resulting record
Source and rationale	Regulation, procedure, trial design, or documented study decision

Rules

1. An expectation applies only when its stated condition is true or a responsible person decides it applies.
2. Requiredness cannot be left blank; unresolved applicability is shown as Pending Decision.
3. Not Required is a governed outcome with reason, decision-maker, date, and plan revision.
4. Count rules must be explainable from trial facts. “As needed” is insufficient unless the deciding event is identified.
5. A changed rule affects future Filing Slots unless the revision explicitly addresses existing ones.
6. The same clinical event cannot generate duplicate Filing Slots from the same expectation.

Filing Slot

Fields

Field	Meaning
Slot identifier	Stable identity for this concrete need
Source Document Expectation	Why the slot exists
Study scope	Exact Study and, when applicable, Country, Site, Person, Organization, Product, Committee, or Event
Trigger fact	The approval, visit, amendment, closure, or other fact that created it
Due date	Calculated date plus the rule and inputs used
Responsible contributor and owner	Who supplies it and who ensures resolution
Milestone	The study milestone affected by the slot
Applicability decision	Required, Not Required, or Pending Decision with reason
Candidate matches	Exact Document Versions proposed as possible evidence
Accepted evidence set	The one approved set of Document Versions that fulfils the slot
Observed deficiencies	Missing when due, late, rejected, inaccessible, or linked Quality Findings; these remain facts
Exception Decisions	Separate governed decisions about an unmet requirement; never stored as a deficiency status

Calculated status

Pending decision
Not yet due
Due — no acceptable match
Evidence under review
Fulfilled
Not required

These are conclusions derived from the slot, its due date, applicability decision, matches, and quality status. A user cannot simply select Fulfilled.

Deficiency indicators and Exception Decisions are shown beside this fulfilment status, not mixed into it. A slot may therefore be Fulfilled and Filed Late, or Due — no acceptable match with an active approved Exception Decision. The decision does not relabel or erase the observed condition.

How Filing Slots relate to Document Versions

A Filing Slot represents one concrete evidence need, not a count bucket.

• One Document Expectation creates zero or many Filing Slots as its applicability and repetition rule is evaluated against actual study facts.
• Each occurrence creates its own Filing Slot. Ten completed monitoring visits create ten slots, not one slot with an expected quantity of ten.
• A Filing Slot has zero or one accepted evidence set at a time.
• An accepted evidence set contains one or more exact Document Versions. More than one is permitted only when the evidence is genuinely composite, such as a report and a separately governed approval retained as distinct TMF Documents.
• One Document Version may contribute to zero, one, or several Filing Slots when each use is explicitly reviewed and clinically justified.
• Candidate matches may be numerous. They do not fulfil the slot until one evidence set is accepted.
• Replacing an accepted evidence set preserves the prior set, decision, reason, and effective period.

This rule prevents one slot from concealing missing repeated records and prevents several candidate uploads from being mistaken for several fulfilled expectations.

Matching a Document Version to a Filing Slot

A match says that one exact Document Version satisfies all or part of a Filing Slot.

Field	Meaning
Filing Slot	The concrete need being addressed
Document Version	The exact final content offered as evidence
Match origin	Suggested automatically or selected manually
Matched by and date	Attribution
Review result	Proposed, Accepted, Rejected, or Excluded
Evidence role	Primary, supporting, approval, signature, translation, or another governed role within the evidence set
Rationale	Required for a combined document, unusual match, exclusion, or rejection

Business rules:

• The match is to an exact Document Version, not merely to the TMF Document.
• A draft, rejected, withdrawn, illegible, or excluded duplicate does not fulfil a Filing Slot.
• Superseding a matched version does not silently move the match to the replacement.
• One Document Version may satisfy several Filing Slots only when it genuinely contains the evidence required by each and that combined use is reviewed.
• One Filing Slot may use several Document Versions only as one reviewed composite evidence set.
• Additional evidence is visible and never improves completeness.

Extra evidence and “overfilled” semantics

A Filing Slot is never Overfilled. It has at most one accepted evidence set, and several versions within that set are legitimate only when the evidence is composite.

Final filed Document Versions that appear relevant but are not in the accepted evidence set are additional evidence requiring reconciliation. They remain candidate evidence until the study team decides whether each is:

• a duplicate to exclude;
• a superseding or superseded version;
• a supporting or related record;
• evidence for another existing Filing Slot;
• evidence that a missing Filing Slot should be generated; or
• unrelated to the Document Expectation.

At the Document Expectation or milestone population level, reporting may show more eligible record occurrences than generated Filing Slots. That is a reconciliation warning, not a Filing Slot status and never a completeness credit.

Milestones

A milestone is a clinical-trial point or period—such as country approval, site activation, first subject visit, database lock, site closeout, or study closeout—against which expected content is reviewed.

Operational milestone completion and TMF completeness are separate facts. Recording an actual milestone date must not turn missing TMF evidence into 100% completeness.

If a milestone is completed with missing or rejected Filing Slots, the model records:

• the actual milestone date;
• the outstanding slots at that time;
• any decision that allowed operations to proceed;
• the person accepting the exception;
• follow-up ownership and due date.

Changes during conduct

Situation	Required treatment
Protocol amendment	Determine which expectations and existing slots change; retain both plan revisions
New country or site	Generate only the Filing Slots applicable to that scope and its actual start point
Country or site withdrawn	Decide each open slot as still required, not required, or required for closeout; never bulk-delete
Visit canceled	Preserve the planned event and cancellation; do not report its report as missing if the expectation condition was never met
Repeating document	Create slots from actual occurrences or an approved forecast, with reconciliation
Expiring qualification	Create a new slot only when the qualification must remain current for an applicable period
Combined evidence	Match explicitly to each slot and explain why one record is sufficient
Erroneous expectation	Correct through a plan/applicability decision with history, not deletion

Audit evidence

For every generated, changed, or resolved Filing Slot, retain who acted, when, the source Filing Plan Revision, the triggering trial fact, the previous and new values, the reason, and any approval. Metrics must be reproducible from this history rather than from the current status alone.