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, milestone, and amendment context to define what is expected, when it is due, and which team owns follow-up.
Protocol and amendment refresh
Effective protocol changes refresh EDL expectations and surface new document obligations.
Country and Site rules
Country, Site, and language requirements stay explicit while Sponsor and CRO teams review completeness.
Due dates and aging
Missing, pending, overdue, and at-risk Essential Documents remain visible 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 Lifecycle status moves through Draft, Effective, Superseded, and Withdrawn with signature and audit evidence where required.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.
Signature-bound effectiveness
Effective transitions can bind signature meaning, signer identity, timestamp, and record hash.
Metadata correction
Correct metadata through controlled correction routes with reason and audit evidence, not hidden edits.
Site exchange and variants
Sites contribute documents without breaking artifact control.
Site exchange, country variants, language variants, and PHI-capable document routes 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 while EDL rules identify which variant is required.
PHI pre-upload handling
Subject-identifiable or sensitive documents route through additional handling before they become ordinary filing work.
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, pending, overdue, and at-risk Essential Documents with due dates and aging.
Live inspector access
Provide scoped, time-bound read and audit-log access to Effective documents, lineage, and inspection checklist answers.
Evidence exports
Export watermarked rendered documents with metadata, signature context, version lineage, audit history, 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.