Versions, renditions, and certified copies

Why version identity matters

A TMF Document is the continuing identity of a trial record. A Document Version is one exact edition of it. The eTMF must show which edition was reviewed, approved, distributed, implemented, filed, superseded, or disclosed during an inspection.

Document Version

Field	Meaning
TMF Document	Continuing record identity
Version number or label	Human-recognizable edition
Version sequence	Unambiguous order within the document
Version purpose	Initial, amendment, periodic update, correction, translation update, or other reason
Author or originator	Who prepared or issued it
Creation, issue, signature, approval, effective, expiry, receipt, and filing dates	Populated when meaningful; each date retains its type
Content components	Main file, appendices, signature pages, or other required parts
Review and approval evidence	Decisions applying to this exact version
Content checksum	Integrity evidence for the exact content
Previous and next version	Version lineage
Replacement reason	Why a later version superseded it

Document Version status journey

Received → In preparation → In review → Final → Superseded
              │               │          └────→ Withdrawn
              └──────────────→ Rejected

• Received: content arrived but may not yet be classified or complete.
• In preparation: content or metadata is being assembled; it does not satisfy a Filing Slot.
• In review: the exact content is undergoing required review or approval.
• Final: no further content editing is permitted; required completion conditions are met.
• Superseded: replaced prospectively but retained for reconstruction.
• Withdrawn: determined not to serve as applicable evidence; history and reason remain.

After Final, an authorized filing action activates the filing placement and may accept the version into a Filing Slot evidence set. Effective date remains metadata describing when the content governs trial conduct; it is not a Document Version status and does not prove that the version was filed.

Finalization rules

Finalization occurs after classification, proposed placement, and the required approval and QC are complete. It occurs before authoritative filing and Filing Slot fulfilment. It requires, as applicable:

• all required content components;
• readable content with no corruption;
• confirmed record type and filing scope;
• required metadata and meaningful document date;
• required signatures, approvals, or certification;
• an acceptable QC result against this exact version and classification;
• no open blocking finding;
• correct blinding, confidentiality, and participant-privacy treatment.

Finalization is refused if any applicable condition is missing. A later metadata or content correction must not make it appear that the corrected values existed at the original finalization time.

Supersession

Supersession means a newer final Document Version replaces an older version for future use. It does not mean the older version was erroneous or can be removed.

The record retains:

• the version relationship and reason;
• when the replacement became final and effective;
• which countries or sites received, acknowledged, approved, or implemented each version;
• Filing Slots satisfied by each version;
• decisions or conduct that occurred while the prior version was current.

Different sites may implement the same protocol amendment on different dates. The model therefore does not assume one study-wide effective date proves implementation everywhere.

Content components

A Document Version may require several inseparable components, such as a main report, appendices, and a signed approval page.

Rules:

1. Component order and role are retained.
2. A signature page cannot silently stand alone without the content it signs.
3. Replacing one component produces a new Document Version.
4. Password-protected, corrupt, incomplete, or unsafe components prevent finalization until resolved.
5. Attachments essential to interpreting an email or decision remain associated with it.

Rendition

A rendition is a viewable representation generated from an exact Document Version, for example a PDF of a spreadsheet or a standardized inspection copy.

Fields include source Document Version, format, generation method, generated time, checksum, fidelity check, intended use, and any lost functionality.

A rendition does not become the source merely because it is easier to view. If formulas, filters, embedded metadata, audit history, or other dynamic behavior are needed to understand the record, the dynamic source is retained and remains retrievable.

Certified copy

A copy that permanently replaces an original must be certified as preserving the original’s content, context, and structure.

Certified-copy evidence

Field	Meaning
Original	Physical or electronic source being replaced
Copy	Exact Document Version created from it
Method	Named-person verification or validated copying process
Verifier and date	Who confirmed fidelity and when
Content comparison	Confirmation that no pages, attachments, annotations, or information are missing
Metadata comparison	Confirmation that required context and structure are preserved
Image quality	Readability, resolution, signatures, handwriting, seals, and meaningful color
Processing changes	Rotation, contrast, cropping, format conversion, or other transformations
QC result	Risk-based check before any original destruction
Original disposition	Retained, returned, or destroyed under separate authorization

Scanning alone does not create a certified copy. Visual enhancement may improve legibility but must not remove or add information. Destroying the original is refused until certification, required QC, retention review, and destruction authorization are complete.

Translation

An original-language document and its translation are related TMF Documents or governed versions as decided by the filing policy; neither silently replaces the other.

Retain:

• source language and translated language;
• exact source Document Version translated;
• translator or translation provider;
• certification or review where required;
• translation date and version;
• countries or sites for which the translation applies.

A changed source version requires an explicit decision about whether a new translation is required.

Corrections after finalization

• Content correction: create another Document Version and state the correction reason.
• Material metadata correction: retain old and new values, reason, actor, time, and required QC.
• Misfile correction: retain the Document Version and correct the filing placement with history.
• Self-evident correction: may use a streamlined path only for approved fields and still leaves attributable correction and verification evidence.