Actions, rules, and audit evidence

Action catalogue

Action	Required before the action	Result	Audit evidence retained
Approve a Filing Plan Revision	Responsibilities, locations, timing, QC, access, and archive arrangements decided	Approved revision awaiting or entering effect	Revision, each decision, approver role, date, signature where required
Generate Filing Slots	Effective plan and verified trial scope or triggering event	Concrete expected record needs	Source expectation, trigger, scope, due calculation, generator, time
Decide applicability	Authorized owner and sufficient study facts	Required, Not Required, or continuing Pending Decision	Prior/new status, rationale, evidence, decider, time
Receive content	Source and original content captured safely	Intake item	Source channel, sender, receiver, time, original metadata, checksum
Classify a TMF Document	Content reviewed; study and filing scope resolved	Record type and context confirmed	Proposed and confirmed values, actor/rule, confidence if automated, time
Revise classification	Corrected record meaning is supported and affected filing is identified	New current classification revision; prior revision superseded	Before/after classification, taxonomy mapping, reason, decision, affected versions and placements
Revise metadata	Correct value and correction authority established	New current metadata revision; prior revision superseded	Before/after values, source, reason, actor, time, review or verification
File a Document Version	Final version, valid current classification and metadata, accepted required QC, valid scope, permission	Proposed placement becomes Active and, when approved, Filing Slot evidence set is accepted	Placement identifier, exact version/classification/metadata/plan pins, scope, role, activator, filed time
End a Filing Placement	Active placement, authorized reason, and any successor placement identified	Placement becomes Ended and cannot be reactivated	Placement identifier, ended by/time, end reason, succeeding placement if any
Confirm an externally held version	Exact external version, owner, location, access, retention, finality, and retrieval verified	Externally held record reference eligible for filing and slot matching	External identity, integrity evidence, verifier, retrieval result, restrictions, time
Match to a Filing Slot	Exact version is suitable evidence	Proposed or accepted fulfilment	Slot, version, matcher, decision, count contribution, rationale
Refile a misclassified version	Incorrect and correct placement identified	Old placement ended; correct placement created	Before/after values, reason, actor, time, QC finding if required
Finalize a Document Version	Required components, metadata, approvals, QC, and access controls complete	Final version whose content can no longer be edited and is eligible for filing	Exact content checksum, conditions, decisions, finalizer, time
Supersede a Document Version	New final version and replacement reason	Earlier version retained as superseded	Version lineage, reason, effective dates, affected matches
Withdraw a version	Authorized decision and impact assessment	Version no longer current evidence	Reason, decision-maker, date, replacement, affected slots
Certify a copy	Original and copy compared by approved person/process	Copy eligible to replace original	Method, verifier, fidelity checks, metadata, date
Open a QC request	Exact review scope, required criterion versions, owner, and due date are known	Assigned governed review	Requester, basis, scope, criteria, assignee, independence rule, due date
Complete a QC round	Exact version/classification/metadata or population fixed; every applicable criterion decided	Accepted, accepted with findings, or rework required	Round number, evidence state, criterion results, reviewer, findings, timestamps
Correct a finding	Correction completed and evidence supplied	Ready for verification	Original issue, correction, new version/metadata/placement, actor, time
Verify a finding	Authorized verifier confirms resolution	Closed, non-issue, or exception decision	Verification evidence, verdict, rationale, verifier, time
Produce a measure snapshot	Scope, cut-off, plan, rule, and population known	Reproducible completeness/timeliness/quality result	Members, exclusions, numerator, denominator, result, producer, time
Assess inspection readiness	Defined scope and supporting retrieval, access, quality, and measure evidence	Dated readiness conclusion	Criteria, evidence, limitations, conclusion, assessor, actions
Provide inspection access	Authorized request, scope, record set, privacy/blinding review	Time-limited read-only access	Approver, recipient, scope, dates, access and export history
Approve archive package	Reconciliation complete and exceptions decided	Package protected for retention	Index, content manifest, checksums, approvals, location, obligations
Transfer archive custody	Approved recipient and verified package	Responsibility/location transferred prospectively	Sender, recipient, manifest, verification, discrepancies, acceptance
Apply or release a hold	Authorized basis and exact scope	Destruction prevented or hold ended	Authority, reason, scope, actor, dates, release decision
Authorize destruction	Retention expired, holds clear, ownership confirmed	Approved records securely destroyed	Eligibility evidence, approvers, manifest, method, certificate

One authoritative document journey

Every record held in the primary eTMF follows the same ordered journey:

1. Receive: preserve the intake content and source evidence.
2. Identify: create or select the TMF Document and create the exact Document Version.
3. Classify and index: approve or prepare the classification revision and metadata revision.
4. Prepare filing: propose the filing placement and candidate Filing Slot matches.
5. Review: complete required content approval and the required QC Round against that exact content, classification revision, metadata revision, and proposed placement.
6. Finalize: prevent further content editing after all blocking conditions pass.
7. File: activate the placement for the final Document Version.
8. Fulfil: accept one evidence set for each Filing Slot that the filed version legitimately satisfies.

Steps 1–4 may be repeated during preparation. Steps 6–8 occur in order. A filed placement cannot be active for a non-final version, and a Filing Slot cannot be fulfilled by a version whose filing placement is merely proposed. If required review later fails because classification or metadata changed, affected filing and fulfilment decisions return to review without altering the historical finalization evidence.

An externally held version uses the same clinical gates, while its responsible source system supplies the native finality evidence and the eTMF records the governed external filing reference.

Exception decision

An exception decision records an authorized choice to proceed despite a stated TMF requirement that is not met. It does not change the underlying fact. A late document remains late; a missing document remains missing; a failed criterion remains failed.

Field	Meaning
Exception identifier	Stable identity
Affected subject	Filing Slot, Document Version, quality finding, milestone, readiness assessment, archive item, or other exact scope
Requirement not met	Filing Plan Revision rule, QC criterion, due date, archive condition, or other governed requirement
Facts and reason	Observable condition and why normal correction is not currently possible or proportionate
Impact assessment	Participant protection, trial reliability, compliance, reconstructability, privacy, blinding, and operational impact
Proposed controls	Corrective action, additional evidence, restricted access, monitoring, or time limit
Requested by and time	Attribution
Required decision roles	TMF, functional, quality, privacy, archive, or other accountable roles based on risk
Decision	Approved, Rejected, or More Information Required
Effective period	Start, expiry, and review date for a temporary decision
Follow-up	Owner, due date, completion, and verification
Closure	Resolved, Expired, Revoked, or Permanently Accepted with authority and reason

Status journey:

Draft → Under review → Approved → Resolved
                   │       ├────→ Expired
                   │       └────→ Revoked
                   ├────────────→ Rejected
                   └────────────→ More information required

An affected item may have several historical exception requests but at most one current approved decision for the same unmet requirement and effective period. Approval is refused if the scope, requirement, impact, responsible approver, controls, or expiry/review treatment is missing. An exception never deletes a Quality Finding or changes historical measure snapshots.

Action	Required before the action	Result	Audit evidence retained
Request an exception	Exact unmet requirement, subject, facts, impact, controls, and proposed period identified	Exception ready for accountable review	Requester, time, requirement, evidence, impact, proposed controls
Decide an exception	All required roles decide with sufficient evidence	Approved, rejected, or returned for information	Each decision, role, rationale, conditions, effective period
Close or revoke an exception	Resolution, expiry, changed risk, or withdrawal established	Historical decision closed without changing underlying facts	Closure reason, evidence, actor, time, affected measures/findings

Rules that must always hold

Filing plan and expectation rules

1. Every Filing Slot traces to the Filing Plan Revision and Document Expectation that created it.
2. Only one Filing Plan Revision governs a study at a given time.
3. Superseding a plan never erases earlier instructions or decisions.
4. Not Required and exception outcomes require a complete, named, dated Exception Decision or applicability decision as appropriate.
5. Operational events create expectations or make them due; they do not create acceptable TMF evidence automatically.
6. A replacement Filing Plan Revision cannot become effective until every old/new expectation and open Filing Slot has a stated reconciliation treatment.

Document and version rules

7. Every filed item has a known TMF Document and exact Document Version.
8. Each TMF Document has exactly one current classification revision; governed metadata has exactly one current revision for its subject.
9. A finalized version retains the exact classification and metadata revisions used for review and filing.
10. Final content cannot be edited; a content correction creates another Document Version.
11. Superseded final versions remain when needed to reconstruct conduct.
12. Filing corrections preserve the incorrect placement and correction history.
13. A rendition remains linked to the exact source version and does not silently replace it.
14. A copy replacing an original has explicit certification evidence.
15. Directly identifying investigator-controlled records do not become sponsor-controlled TMF content.

Fulfilment and measure rules

16. A Filing Slot is fulfilled only by its one accepted evidence set containing one or more exact Document Versions.
17. Each repeated occurrence has its own Filing Slot; quantity is never hidden inside one slot.
18. Draft, rejected, withdrawn, illegible, and excluded duplicate versions do not contribute to current completeness.
19. Additional evidence never improves completeness and is not a Filing Slot status; it requires reconciliation.
20. Late filing may restore completeness but never erases lateness.
21. Every reported measure retains scope, cut-off, plan, rule, population, numerator, denominator, and exclusions.
22. Operational milestone completion does not imply TMF completeness or inspection readiness.
23. An Exception Decision never changes the underlying missing, late, failed, or inaccessible fact.

Quality and access rules

24. A QC result applies only to the exact Document Version, classification revision, metadata revision, criterion versions, and scope reviewed.
25. One QC Request retains every QC Round; a successful later round never erases failed earlier rounds.
26. Corrected and verified are separate outcomes.
27. A closed finding retains its original observation, correction, verification, and decision history.
28. Access requires study scope, responsibility, confidentiality, privacy, and blinding permission.
29. Archived and inspection access is read-only and attributable.

Archive rules

30. Archive approval requires a reconciled index, content, metadata, audit evidence, Exception Decisions, and integrity manifest.
31. Transfer changes responsibility prospectively and preserves prior custody history.
32. A failed archive retrieval test creates a quality issue and recovery obligation.
33. Destruction requires expiry of all obligations, release of all holds, ownership confirmation, authorization, and a certificate.

Refusal catalogue

The product must clearly explain why it refuses to:

• approve a filing plan with unowned records or inaccessible locations;
• mark a Filing Slot Not Required without a reason and responsible decision-maker;
• count an upload before classification, QC acceptance, and exact version matching;
• finalize incomplete, illegible, unsigned, misclassified, or improperly exposed content;
• overwrite a final Document Version;
• silently move matches from a superseded version to a replacement;
• delete content merely because it appears duplicated;
• claim that a scan is certified without certification evidence;
• allow blinded users to see unblinded content;
• allow sponsor access to directly identifying investigator-controlled records;
• close a blocking finding without required verification;
• report a measure with a hidden denominator or changed historical rule;
• claim inspection readiness without retrieval, access, audit-history, and quality evidence;
• archive an unreconciled TMF without declared exceptions;
• destroy content under an active retention obligation or hold.

Minimum audit statement

For each material action, retain:

• who or what acted and the clinical/TMF role used;
• date, time, and time zone;
• the exact Study, Filing Plan Revision, Filing Slot, TMF Document, and Document Version affected;
• previous and new values or statuses;
• reason and supporting evidence;
• required review, approval, or signature;
• automatic rule/model/procedure version when automation participated;
• resulting relationships, findings, measures, exports, or disclosures.

The audit evidence must allow reconstruction without relying on application logs that have lost the clinical meaning of the action.