Reference model and filing plan

Why both are needed

A Reference Model Release names and organizes common types of trial records. A Filing Plan Revision says how one actual study will use that taxonomy. The reference model is not a universal checklist, and the filing plan is not merely a copy of it.

The Filing Plan Revision must reflect the protocol, trial design, countries, sites, committees, service providers, investigational products, systems, risk-proportionate approach, and division of responsibilities that genuinely apply to the study.

Reference Model Release

Information retained

Field	Clinical meaning
Release identifier and version	The exact published edition being interpreted
Publication and effective dates	When the release became available and usable
Status	Draft, Published, or Retired
Zone and section	The broad trial process and filing grouping
Artifact code and name	Stable identification of a kind of trial evidence
Artifact purpose	What conduct or decision the evidence helps reconstruct
Typical filing level	Study, Country, Site, or another stated scope
Responsibility guidance	Sponsor, investigator/institution, or both
Core or recommended guidance	Whether the artifact is generally expected when produced
Date convention	The meaningful date normally used to order that record type
Blinding and privacy considerations	Whether access may reveal treatment or participant identity
Change from prior release	Added, renamed, moved, split, combined, or retired content

Business rules

A published Reference Model Release is never edited in place.
A release describes kinds of evidence; it does not contain study records or Filing Slots.
Adopting a new release does not silently alter an active or archived study.
A retired release remains readable for studies that used it.
Local terminology may map to the reference terminology, but the mapping and rationale remain visible.
A core artifact is retained when produced; it does not mean that the underlying activity must occur in every trial.

Complete reference hierarchy

The reference taxonomy is retained as a governed hierarchy rather than a text value on a document.

Reference Model Release
└── one or more Zone Definitions
    └── one or more Section Definitions
        └── one or more Artifact Definitions

Definition	Required information
Zone Definition	Stable zone identity, code, name, purpose, display order, release
Section Definition	Stable section identity, code, name, purpose, parent zone, display order, release
Artifact Definition	Stable artifact identity, code, name, purpose, parent section, filing guidance, responsibility, dates, blinding/privacy, release

Each definition belongs to exactly one Reference Model Release. A Section Definition has exactly one parent Zone Definition in that release; an Artifact Definition has exactly one parent Section Definition. Lineage between releases states whether a definition is unchanged, renamed, moved, split, combined, new, or retired. A move between sections is therefore not mistaken for a new clinical meaning.

Organization filing taxonomy and mappings

An organization filing taxonomy is the governed vocabulary used in its Filing Plan Revisions. It may adopt reference terms directly or document necessary local differences.

Field	Meaning
Taxonomy version and effective period	Exact organization vocabulary in force
Reference Model Release	External release used as the comparison basis
Local zone, section, and record type	Organization filing hierarchy and plain-language meaning
Governance status	Draft, Approved, Effective, or Superseded
Change rationale	Why content was added, renamed, split, combined, moved, or retired

A taxonomy mapping relates one local record type to zero, one, or several Artifact Definitions. An Artifact Definition may map to zero, one, or several local record types. The mapping states:

Exact Equivalent;
Broader Local Type;
Narrower Local Type;
Combined Reference Artifacts;
Local Extension with No Reference Artifact;
Reference Artifact Not Used Locally; or
Pending Decision.

Every mapping retains the organization taxonomy version, Reference Model Release, reviewer, decision date, rationale, and effective period. A broad or combined mapping must explain how filing, expectations, metrics, and inspection navigation avoid ambiguity. A local extension must state its clinical purpose.

Filing Plan Revision

A Filing Plan Revision is the study team’s approved instruction for maintaining the TMF during a defined period.

Information retained

Area	Required information
Identity	Study, revision number, status, approval date, effective-from date, superseded revision
Basis	Reference Model Release, protocol version, study-design assumptions, applicable procedures
Responsibility	Sponsor TMF owner, study TMF lead, functional record owners, service-provider responsibilities, investigator/institution responsibilities
Record locations	Primary eTMF, investigator site files, email archive, safety system, training location, statistical environment, and other declared locations
Filing instructions	Document Expectations, filing scopes, meaningful document dates, naming or indexing conventions
Timing	What starts each filing clock, allowed filing period, escalation path, exceptions
Quality	Record-level QC, TMF-level QC, sampling or risk rules, blocking findings, verification responsibility
Access	Study scope, blinded/unblinded restrictions, confidential records, inspection access
Copies	Scanning, certified-copy process, original-retention rules, dynamic record handling
Correspondence	Which decisions and communications are essential and where they are retained
Completion	Milestone review, closeout reconciliation, archive preparation, unresolved exceptions
Continuity	What happens if a service provider, sponsor, or investigator institution can no longer maintain its records

Status journey

Draft → In review → Approved → Effective → Superseded
             └──────────────→ Rejected

Draft: being prepared; it creates no approved Filing Slots.
In review: affected functions and responsible parties confirm feasibility and ownership.
Approved: all required decisions are recorded, but its effective date may be in the future.
Effective: governs TMF activity for its stated period.
Superseded: replaced prospectively; it remains the explanation for earlier activity.

Only one Filing Plan Revision may be effective for a study at a given moment. A correction to an approved plan creates another revision rather than rewriting the approved instructions.

Filing Plan reconciliation

Before a replacement Filing Plan Revision becomes effective, the study team reconciles it to the currently effective revision. Reconciliation makes the treatment of every affected Document Expectation and open Filing Slot explicit.

Field	Meaning
Current and proposed revisions	Plans being compared
Reason for revision	Amendment, scope, responsibility, location, taxonomy, timing, QC, access, or archive change
Expectation mapping	Unchanged, New, Replaced, Split, Combined, or Retired
Filing Slot treatment	Continue under prior rule, move prospectively, replace, split, combine, decide Not Required, or close by approved exception
Due-date treatment	Retain original date or recalculate prospectively with reason
Existing matches and findings	Whether they remain valid and why
Measure impact	Historical snapshots preserved; future population change identified
Responsible reviewers and decisions	Functional and TMF confirmation
Unresolved items	Owner, due date, and whether they block effectiveness

Every expectation in the current revision and every expectation in the proposed revision appears in the reconciliation. Every open Filing Slot has one stated treatment. A proposed revision cannot become effective while a blocking item has no treatment. Reconciliation never moves historical Filing Slots or recalculates historical measures silently.

Declared record location

An essential record may be kept outside the primary eTMF when the arrangement remains controlled.

Field	Required meaning
Location	Named system, archive, institution, or physical record store
Responsible party	Who maintains integrity, confidentiality, availability, and retention
Records covered	Exact record types or study processes held there
Authority	Whether this is the authoritative record or a convenience copy
Access	Who may retrieve it, how, and under what restrictions
Retention	Which obligation governs it and who prevents premature destruction
Transfer/export	How the record and its metadata will be delivered at closeout or termination
Retrieval check	Last successful test, tester, result, and unresolved problem

A URL alone is not a declared record location. The model refuses approval if responsibility, retention, accessibility, and a workable transfer or archive arrangement are unknown.

Externally held record reference

A declared record location describes a controlled place. An externally held record reference identifies one exact TMF Document and Document Version that remains authoritative in that place.

Field	Meaning
TMF Document	Clinical identity of the essential record
Document Version	Exact external edition being relied upon
Declared record location	Approved system, institution, or archive holding it
External identifier and locator	Stable identity and retrieval route in that location
Record type and filing scope	Classification, Study, Country, Site, or other context
Version and dates	External version label, document date, finalization/effective date where applicable
Integrity identity	Checksum, signature, external content fingerprint, or explained alternative
Responsible owner and custodian	Who owns the record and who keeps it
Access restrictions	Authorization, privacy, blinding, and direct-identifier controls
Availability and retention	Required availability period, obligations, and transfer arrangement
Last retrieval verification	Tester, time, version retrieved, result, and evidence
Metadata and audit-history availability	What context and change history can be produced
Failure treatment	Owner, escalation, recovery path, and Filing Slots affected

One declared location may hold many externally referenced records. Each externally held record reference identifies exactly one TMF Document and exact Document Version. A Document Version has at most one authoritative location at a time; moves preserve prior custody and location history.

An externally held version may fulfil a Filing Slot only when it has passed the same applicable classification, metadata, QC, finalization, and matching decisions as content in the primary eTMF and the version can be retrieved. A bare URL, a current system screen without version identity, or an unverified promise that a service provider holds the record cannot fulfil a slot.

When the external system owns the document status journey, the eTMF retains the external decision evidence and maps it to the same clinical journey: exact version identified, required QC accepted, finality confirmed, authoritative external filing recorded, and Filing Slot evidence set accepted. The eTMF does not pretend it finalized content that another responsible system finalized.

Actions and retained evidence

Action	Required before it can occur	Evidence retained
Publish a Reference Model Release	Complete governed taxonomy and change review	Publisher, time, content fingerprint, release notes
Adopt a release for organizational use	Approved mapping and treatment of local differences	Approvers, mappings, rationale, effective date
Submit a Filing Plan Revision for review	Responsibilities, locations, rules, and exceptions are populated	Submitter, time, revision content
Approve a Filing Plan Revision	All required functions have decided; no unresolved ownership or archive gap	Each decision, role, signature where required, date
Make a revision effective	Approval complete and effective date reached	Activation actor or policy, time, previous revision
Reconcile a replacement revision	Every old/new expectation and every open Filing Slot has a treatment	Reconciliation mapping, reviewers, decisions, measure impact
Supersede a revision	Replacement is approved	Link between revisions and change rationale
Register another record location	Responsible party, access, retention, and retrieval are known	Location declaration and approval
Register an externally held record	Exact record/version, classification, location, owner, access, retention, and retrieval evidence known	Governed reference eligible for review and matching

Events that may require a new revision

Protocol amendment changes trial procedures or required evidence.
A country, site, committee, laboratory, or service provider is added or removed.
Sponsor and service-provider responsibilities change.
A source system, archive, or email record location changes.
Filing timelines or QC expectations change.
Blinding, privacy, or access arrangements change.
A new reference-model release is intentionally adopted.
An inspection, audit, or quality review reveals that the current plan is inadequate.

Not every event forces a revision. The TMF lead records whether the current plan already expresses the change. That decision and its reason remain available.