Zone, Section, Artifact
Classify documents against the CDISC TMF Reference Model spine instead of a custom folder convention.
eTMF
An eTMF that stays inspection-ready as the study changes.
When a protocol amendment, site activation, or country requirement changes, expected documents, version history, site follow-up, and inspector access move with it.
CDISC TMF Reference Model taxonomy
Use the CDISC TMF hierarchy as the filing spine.
The TMF starts with the expected filing structure. Zone, Section, and Artifact mapping aligns Essential Documents to a recognizable taxonomy. Quality disposition accepts or corrects AI-suggested Zone, Section, and Artifact classification before the filing decision enters the TMF audit trail.
Essential Document alignment
Connect expected artifacts to protocol, country, Site, milestone, and amendment context.
Reviewer-confirmed classification
AI can suggest classification, but reviewer disposition preserves the evidence trail.
EDL rules
Expected documents should come from trial context.
EDL rules use Protocol Version, country, Site, and milestone context to define what is expected and when it is due.
Protocol and amendment refresh
Effective protocol changes refresh EDL expectations and surface new document obligations.
Country and Site rules
Country and Site requirements stay explicit while teams review completeness.
Due dates and aging
Missing and overdue Essential Documents remain visible with due dates and aging, without a monthly spreadsheet.
WORM and lifecycle
Content stays immutable from upload; status remains controlled.
Document content is protected from the moment it lands. Lifecycle status moves through Draft, Effective, Superseded, and Withdrawn with signature and audit evidence where required.
WORM content
Uploaded content stays immutable; later changes create new versions rather than overwriting evidence.
Part 11 signatures
Electronic signatures bind meaning, signer identity, timestamp, and a hash of the signed record.
Metadata correction
Correct metadata through a controlled route that records the change in the audit trail, not hidden edits.
Site exchange and variants
Sites contribute documents without breaking artifact control.
Site exchange, country variants, and language variants stay tied to the same artifact model and review workflow.
Site document requests
Route requests and follow-up to Sites with study, Site, artifact, and due-date context.
Country and language variants
Variants stay tied to the same Artifact rather than splitting into a parallel filing structure.
Completeness and live inspection
Inspection access should open the live TMF, not a rebuilt package.
Inspection work depends on completeness, due dates, effective documents, access windows, audit evidence, and exportable lineage.
Completeness views
Show missing and overdue Essential Documents with due dates and aging.
Live inspector access
Provide scoped, time-bound read and audit-log access to Effective documents and their version lineage.
Evidence exports
Export watermarked rendered documents with metadata, version lineage, request id, and timestamp.
First rollout
Bring the study question your team keeps rebuilding.
We will review the product path, system context, owners, evidence, and rollout approach that fit the trial work in front of you.