Study TMF Structure
Organize clinical trial documentation by study, region, country, site and third-party scope using a TMF Reference Model hierarchy.
e-line ecosystem
eTMF
Electronic Trial Master File Platform
Manage clinical trial documentation, TMF completeness, reconciliation, inspection readiness and audit evidence in one controlled platform.
eTMF helps sponsors, CROs and study teams organize essential documents around studies, countries, sites, third parties, milestones and TMF Reference Model artifacts. It connects document collection, versioning, review, completeness scoring, reconciliation, audit trail and inspection preparation without turning clinical operations into a generic file repository.
The TMF control gap
Clinical trial documentation is too critical to be managed across folders, emails and manual completeness trackers
Trial Master File management involves study structure, country and site documents, essential artifacts, milestones, sponsors, CROs, inspectors, versions, approvals and long retention periods. When this work is spread across shared drives, spreadsheets and local tracking, teams lose visibility into what is expected, what is missing and what will stand up to inspection.
eTMF brings TMF structure, study documents, completeness expectations, reconciliation, audit evidence and inspection preparation into one structured management layer.
What eTMF helps you manage
eTMF connects clinical documentation, TMF structure, document expectations, inspection readiness and compliance evidence in one operational platform.
Documents & Versions
Manage essential documents, major and minor versions, metadata, lifecycle status and controlled file history for each artifact.
Study Templates
Use study-specific templates to define expected artifacts, essentiality, scope rules, milestones and completeness requirements.
Health Score & Gaps
Calculate completeness against study expectations and surface missing critical, major, minor and expected documents.
Reconciliation
Track expected versus actual documents per artifact and scope entity, with statuses such as missing, reconciled or present not final.
Inspection Readiness
Prepare inspection views, audit sessions, TMF viewer access and traceable evidence for study and document review.
Audit Trail & e-Signatures
Record controlled actions in append-only audit history and support electronic signature evidence with re-authentication.
Roles, DRM & Permissions
Control study team access, scoped permissions and Delegation & Responsibility Matrix assignments across TMF artifacts.
Archive & Retention
Export and import self-contained study archives with metadata, documents, audit trail, signatures, templates and codelist snapshots.
AI Smart Actions
Use optional AI-assisted checks for document review, study readiness, risk narratives, audit summaries and entity-specific insights.
One platform for TMF completeness and inspection control
From study setup to document collection, reconciliation, inspection review and long-term archive, eTMF gives clinical teams a structured workspace for controlled trial documentation.
01
Build each study around a clear TMF operating model
Define the study, sponsor, CRO, regions, countries, sites, third parties, milestones and team assignments. eTMF keeps the clinical trial context connected to the documents and artifacts that must be collected.
02
Navigate documents through the TMF Reference Model
Use the Zone > Section > Artifact hierarchy to browse expected documents and actual submissions. Scope-aware artifacts make it clear whether a document belongs to the study, region, country, site or third-party level.
03
Track completeness, risks and reconciliation status
Study templates expand into document expectations. Health score, gaps, risks and reconciliation views help teams understand what is missing, what is not final and which issues could affect inspection readiness.
04
Control versions, approvals and evidence
Document versions preserve uploaded files, lifecycle changes, signatures and audit trail. Approved documents can be superseded when a new version is uploaded, keeping review history and status transitions traceable.
05
Prepare inspection and archive packages
Inspection dashboards, audit sessions, document inventory export and long-term study archive export help clinical teams retrieve evidence without reconstructing study history from separate systems.
Ecosystem
Built for the e-line ecosystem
eTMF is designed as the clinical trial documentation and inspection-readiness layer within the e-line ecosystem. It can connect study oversight, documents, regulatory milestones, quality evidence and portfolio context while keeping TMF artifacts, versions, reconciliation and inspection records under dedicated control.
eTMF does not replace project, regulatory or document domain systems. It connects clinical trial records with the wider pharmaceutical lifecycle.
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Artwork execution follows regulatory and launch change context.
Supporting systems across the lifecycle
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Typical use cases
eTMF answers practical clinical operations questions around completeness, evidence, inspection readiness and collaboration.
Study TMF oversight
- Which studies have low TMF completeness?
- Which regions, countries or sites are missing critical documents?
- Which milestones are overdue or approaching?
- Which study teams need management attention?
Document collection and review
- Which artifact is expected for this scope?
- Which document version is current?
- Which documents are draft, in review or approved?
- What changed since the previous upload?
Inspection preparation
- Is the study ready for inspection?
- Which gaps should be explained or reconciled?
- Which audit trail events are relevant?
- Can the inspector view the required evidence quickly?
Sponsor and CRO collaboration
- Who is responsible for this artifact?
- Which study group can upload or approve documents?
- Which third-party records are incomplete?
- Which actions need notifications or follow-up?
AI Smart Actions
AI-assisted TMF review and readiness insight
eTMF can help teams turn structured study and document data into focused review outputs. AI Smart Actions can summarize document versions, explain health scores, identify missing evidence, prepare study readiness narratives, support audit summaries and highlight entity-specific risks using available system data.
Summarize study inspection readiness.Explain the current TMF health score.Identify missing critical documents.Prepare a study audit summary.Compare this document version with the previous one.Assess country or site activation readiness.
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Clinical TMF fit
Designed around clinical trial documentation reality
eTMF supports TMF Reference Model structures, study templates, country and site scope, milestone-driven expectations, document lifecycle control, completeness heatmaps, reconciliation, audit sessions, electronic signature evidence, role-based access and long-term archives. It is built for teams that need more than a folder structure, but do not want inspection readiness hidden in spreadsheets.
Benefits
What eTMF helps you achieve
Better visibility across study, country, site and third-party TMF documentation
Clearer control of expected artifacts, actual documents and lifecycle status
Earlier identification of missing critical documents, overdue milestones and inspection risks
Stronger traceability through version history, audit trail and electronic signature evidence
More structured reconciliation of expected versus collected documentation
Faster preparation for inspections, audit sessions and management reviews
Better collaboration between sponsors, CROs, clinical monitors and study teams
Reduced dependency on spreadsheets, shared folders and manual completeness trackers
Support for long-term study archive export and regulated retention scenarios
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Bring structure, completeness and inspection readiness to your Trial Master File
See how eTMF can help your clinical teams manage study documents, TMF artifacts, completeness, reconciliation, audit evidence and inspection preparation in one connected platform.
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