Archive, retention, and export

Archive begins with reconciliation

Archiving is not simply changing a status or moving files. The responsible parties must establish what the complete TMF comprises, where every authoritative record is held, which exceptions remain, and whether the records and their history can be retrieved throughout the retention period.

Closeout reconciliation

The reconciliation covers:

• all applicable Filing Slots and their accepted Document Version matches;
• missing, late, rejected, additional-evidence, and Not Required outcomes, kept separately from Exception Decisions;
• sponsor, investigator/institution, and service-provider portions;
• every declared external record location;
• every externally held record reference and exact Document Version;
• superseded and withdrawn versions needed for reconstruction;
• relevant correspondence and attachments;
• dynamic sources, renditions, translations, and certified-copy evidence;
• open quality findings and approved disposition;
• classification and metadata completeness;
• audit history and access history;
• records still held by a party that must transfer them;
• archive responsibility, retention obligations, and retrieval arrangements.

Closing a study does not automatically prove that this reconciliation is complete.

Archive package

Field	Meaning
Archive package identifier	Stable identity for this controlled package
Study and scope	Sponsor portion, investigator portion, country/site subset, or full defined TMF
Archive cut-off	Last content and history included
Filing Plan Revision history	Instructions needed to interpret the package
Record index	TMF Documents, exact Document Versions, filing placements, and Filing Slot relationships
Content	Source components, required renditions, translations, and certified copies
Metadata and audit evidence	Context, versions, decisions, corrections, access, and transfer history
Manifest and checksums	Integrity and package-verification evidence
Observed deficiencies	Missing, late, rejected, inaccessible, or unreconciled evidence retained as facts
Exception Decisions	Separate approvals, controls, effective periods, and follow-up for unmet requirements
Archive owner and custodian	Responsible party and physical/technical keeper
Archive location	Controlled location and access method
Retention schedule	Applicable obligations, triggers, and calculated dates
Approval	Persons confirming reconciliation and archive acceptance

For an externally held record, archive reconciliation must either include a verified retained external arrangement for the full obligation or transfer the exact version, metadata, relationships, and audit evidence into the archive. A locator to a system that will be decommissioned is not an archive record.

Status journey

Preparation → Reconciliation → Approved for archive → Archived
                                                      ↓
                                           Destruction eligible → Destroyed

Preparation returns to reconciliation whenever verification finds an omission or integrity problem.

Archived content rules

1. Archived content is protected against ordinary editing and deletion.
2. Access is restricted to authorized persons and is read-only.
3. Retrieval, export, custody transfer, and any permitted administrative change remain auditable.
4. Periodic retrieval and integrity tests prove continued readability and availability.
5. A failed test creates a quality issue and recovery action; it is not merely a technical alert.
6. Format or media migration preserves content, context, structure, metadata, relationships, and audit evidence.
7. The archive index and retention rules remain usable even when original study personnel are unavailable.

Retention obligation

No universal number of years is sufficient for all trials and records.

Field	Meaning
Authority	Regulation, marketing authorization, contract, sponsor policy, litigation, or other basis
Jurisdiction and scope	Which study records and parties it covers
Trigger	Study completion, discontinuation, approval, product status, or other defined event
Minimum period or end date	Required retention
Responsible party	Who ensures the obligation is met
Evidence	Source rule and calculation inputs

The effective retention end is the latest applicable obligation for the record scope.

Retention hold

A hold prevents destruction despite the ordinary retention date.

Fields include reason, authority, record scope, applied by and date, review date, release decision, release authority, and any continuing restrictions. A hold may apply to the whole study or a defined subset and must be checked at destruction time, not merely when first recorded.

Archive custody transfer

Transfer may occur because of acquisition, service-provider termination, archive-provider change, investigator retirement, or institutional closure.

Required steps:

1. Identify the current owner, custodian, package, obligations, and holds.
2. Approve the receiving owner or custodian and access arrangements.
3. Produce a transfer manifest with exact package checksums.
4. Transfer without creating an untracked gap in custody or availability.
5. Have the recipient verify completeness, integrity, readability, metadata, and retrieval.
6. Record acceptance, discrepancies, correction, and the effective transfer date.
7. Update location and responsibility history without rewriting the previous arrangement.

The sponsor may delegate custody but retains the responsibilities that applicable requirements place on it.

Export package

An export supports inspection, audit, transfer, acquisition, migration, or controlled access.

Field	Meaning
Purpose and recipient	Why the export exists and who receives it
Scope and cut-off	Exact Study, Country, Site, record types, dates, and versions
Included records	TMF Documents and exact Document Versions
Filing index and metadata	How the content is located and understood
Audit evidence	Included history and any stated limitations
Transformations	Renditions, format conversion, redaction, naming change, or packaging
Omissions	Excluded content and reasons
Manifest and checksums	Verification evidence
Chain of custody	Preparer, sender, recipient, times, and receipt confirmation
Verification result	Whether the recipient could open, reconcile, and understand it

Export success requires recipient verification where the purpose is transfer or archive migration. An export does not change the authoritative record location unless an approved custody transfer occurs.

Destruction

Destruction is allowed only when:

• every applicable retention obligation has expired;
• no hold applies;
• the record scope is exact and independently checked;
• the responsible owner authorizes destruction;
• investigator/institution and sponsor ownership boundaries are respected;
• destruction is secure and appropriate to the media;
• a destruction certificate records what was destroyed, why, when, how, and by whom.

The model refuses destruction based on a generic study status, one calculated date, an expired service contract, or a request from a person who is not the responsible record owner.